An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis

• Sponsor: Janssen Pharmaceutical K.K. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02325219
• Collaborator: (none)
• Enrollment: 192
• Locations: 27
• Arms: 3
• Actual Duration (Months): 49.7
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate the superiority of CNTO 1959 (guselkumab) to placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches).

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: CNTO 1959 50 mg; Drug: CTNO 1959 100 mg; Drug: Placebo 50 mg; Drug: Placebo 100 mg	Phase 3

Detailed Description

A Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know about the study treatment), placebo-controlled (a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of CNTO 1959 (Guselkumab) in the treatment of participants with moderate to severe plaque-type psoriasis. Participants will receive either treatment of CNTO 1959 (guselkumab) 50 milligram (mg) or 100 mg or Placebo 50 mg or 100 mg. Participants will primarily be assessed for Investigator's Global Assessment (IGA) Score and Psoriasis Area and Severity Index (PASI). Participants' safety will be monitored throughout the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
• Actual Study Start Date: Dec 19, 2014
• Actual Primary Completion Date: Mar 2, 2016
• Actual Study Completion Date: Feb 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Participants will receive subcutaneous injection of CNTO 1959 50 milligram (mg) and placebo 100 mg at Week 0, 4 and then every 8 weeks thereafter.	Drug: CNTO 1959 50 mg; Participants will receive subcutaneous injection of CNTO 1959 50 mg.; Other Names: Guselkumab ; Drug: Placebo 100 mg; Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.
Experimental: Group 2 Participants will receive subcutaneous injection of CNTO 1959 100 milligram (mg) and placebo 50 mg at Week 0, 4 and then every 8 weeks thereafter.	Drug: CTNO 1959 100 mg; Participants will receive subcutaneous injection of CNTO 1959 100 mg.; Other Names: Guselkumab ; Drug: Placebo 50 mg; Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg.
Experimental: Group 3 Participants will receive subcutaneous injection of placebo 50 mg and 100 mg at Weeks 0, 4 and 12. At Week 16, participants will be randomized in sub-group 3a to receive either CNTO1959 50 mg and placebo 100 mg at Week 16, 20 and then every 8 weeks thereafter or sub-group 3b to receive CNTO 1959 100 mg and placebo 50 mg at Week 16, 20 and then every 8 weeks thereafter.	Drug: CNTO 1959 50 mg; Participants will receive subcutaneous injection of CNTO 1959 50 mg.; Other Names: Guselkumab ; Drug: CTNO 1959 100 mg; Participants will receive subcutaneous injection of CNTO 1959 100 mg.; Other Names: Guselkumab ; Drug: Placebo 50 mg; Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg.; Drug: Placebo 100 mg; Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 [Week 16]

   The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

2. Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 [Week 16]

   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.

Secondary Outcome Measures

1. Percentage of Participants Who Achieved PASI 75 Response at Week 16 [Week 16]

   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.

2. Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 [Baseline and Week 16]

   The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

3. Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16 [Weeks 2, 4, 8, 12, and 16]

   The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

4. Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52 [Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52]

   The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

5. Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16 [Weeks 2, 4, 8, 12, and 16]

   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.

6. Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52 [Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52]

   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.

7. Percent Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16 [Baseline and Weeks 2, 4, 8, 12, 16]

   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

8. Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52 [Baseline and Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52]

   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

9. Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16 [Baseline and Weeks 2, 4, 8, 12, 16]

   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

10. Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52 [Baseline and Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52]

    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

11. Change From Baseline in Body Surface Area (BSA) Involvement by Psoriatic Lesions at Week 48 [Baseline and Week 48]

    BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.

12. Change From Baseline in Nail Psoriasis Area and Severity Index (NAPSI) Score at Week 16 [Baseline and Week 16]

    NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).

13. Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52 [Baseline and Weeks 28, 36, 48, 52]

    NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).

14. Percent Change From Baseline in NAPSI Score at Week 16 [Baseline and Week 16]

    NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).

15. Percent Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52 [Baseline and Weeks 28, 36, 48, 52]

    NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).

16. Percentage of Participants With a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Week 16 [Week 16]

    The percentage of participants with an ss-IGA score of absence of disease (0) or very mild disease (1) and at least a 2-grade improvement from Baseline at Week 16 among participants who had an ss-IGA score of >= 2 at baseline was evaluated. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).

17. Percentage of Participants With an Ss-IGA Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Weeks 28, 48 and 52 [Week 28, 48 and 52]

    The percentage of participants with an ss-IGA score of absence of disease (0) or very mild disease (1) and at least a 2-grade improvement from Baseline at Week 16 among participants who had an ss-IGA score of >= 2 at baseline was evaluated. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).

18. Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 16 [Week 16]

    The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).

19. Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52 [Week 28, 48 and 52]

    The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).

20. Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 8 and 16 [Weeks 8 and 16]

    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

21. Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 28, 36, 48, and 52 [Weeks 28, 36, 48, and 52]

    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

22. Change From Baseline in the DLQI Total Score at Week 8 [Baseline and Weeks 8]

    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

23. Change From Baseline in the DLQI Total Score at Weeks 28, 36, 48, 52 [Baseline and Weeks 28, 36, 48, 52]

    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

24. Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 8 and 16 [Weeks 8 and 16]

    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

25. Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 28, 36, 48, and 52 [Weeks 28, 36, 48, and 52]

    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

26. Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Week 16 [Baseline and Week 16]

    The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

27. Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Weeks 28 and 48 [Baseline and Weeks 28, 48]

    The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

28. Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 16 [Baseline and Week 16]

    The EQ visual analog scale (EQ VAS) is the part of EQ-5D scale. The EQ VAS records the respondent's self-rated health on a vertical, visual analog scale where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0).

29. Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Weeks 28, 48 [Baseline and Weeks 28, 48]

    The EQ visual analog scale (EQ VAS) is the part of EQ-5D scale. The EQ VAS records the respondent's self-rated health on a vertical, visual analog scale where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0).

30. Change From Baseline in the Physical and Mental Component Summary (PCS and MCS) Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Week 16 [Baseline and Week 16]

    SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.

31. Change From Baseline in the PCS and MCS Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 28 and 48 [Baseline and Weeks 28, 48]

    SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.

32. Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Week 16 [Baseline and Week 16]

    Changes from baseline in the 4 types (absenteeism, activity impairment, presenteeism, and Work productivity loss) of WPAI scores at Week 16 were evaluated. The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.

33. Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48 [Baseline and Weeks 28, 48]

    Changes from baseline in the 4 types (absenteeism, activity impairment, presenteeism, and Work productivity loss) of WPAI scores at Weeks 28 and 48 were evaluated. The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.

34. Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16 [Weeks 4, 8, and 16]

    ACR Response is defined as percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in swollen joint (66 joints) and tender joint (68 joints) counts and percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in 3 of following 5 assessments: patient's assessment of pain using VAS (VAS; 0-10, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity by using VAS (scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).

35. Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52 [Weeks 28, 36, 48, and 52]

    ACR Response is defined as percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in swollen joint (66 joints) and tender joint (68 joints) counts and percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in 3 of following 5 assessments: patient's assessment of pain using VAS (VAS; 0-10, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity by using VAS (scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).

36. Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16 [Weeks 4, 8, and 16]

    Percent change from baseline in the tender joints and swollen joints counts at Weeks 4, 8, and 16 was evaluated.

37. Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52 [Weeks 28, 36, 48, and 52]

    Percent change from baseline in the tender joints and swollen joints counts at Weeks 28, 36, 48 and 52 was evaluated.

38. Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16 [Baseline and Weeks 4, 8, 16]

    Change from baseline in the tender joints and swollen joints counts at Weeks 4, 8, and 16 was evaluated.

39. Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52 [Baseline and Weeks 28, 36, 48, 52]

    Change from baseline in the tender joints and swollen joints counts at Weeks 28, 36, 48 and 52 was evaluated.

40. Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 4, 8, 16 [Baseline and Weeks 4, 8, 16]

    Percent change from baseline in Patient's Assessment of Pain (VAS) among participants who had a diagnosis of PsA at screening at Weeks 4, 8 and 16 was evaluated. Each participant assessed his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 millimeter (mm) (no pain) to 100 mm (the worst pain imaginable).

41. Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 28, 36, 48, 52 [Baseline and Weeks 28, 36, 48, 52]

    Percent change from baseline in Patient's Assessment of Pain (VAS) among participants who had a diagnosis of PsA at screening at Weeks 28, 36, 48 and 52 was evaluated. Each participant assessed his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).

42. Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 4, 8, 16 [Baseline and Weeks 4, 8, 16]

    The participant's and physician's global assessments of disease activity were recorded on a VAS. The VAS for the participant's assessment ranges from "very well" (0 centimeter [cm]) to "very poor" (10 cm).

43. Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 28, 36, 48, and 52 [Baseline and Weeks 28, 36, 48, 52]

    The participant's and physician's global assessments of disease activity were recorded on a VAS. The VAS for the participant's assessment ranges from "very well" (0 cm) to "very poor" (10 cm).

44. Percentage of Participants Who Achieved Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Weeks 4, 8 and 16 [Weeks 4, 8, and 16]

    HAQ-DI response was defined as change of less than or equal to (<=) -0.3 from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning).

45. Percentage of Participants Who Achieved HAQ-DI Response at Weeks 28, 36, 48, 52 [Weeks 28, 36, 48, 52]

    HAQ-DI response was defined as change of less than or equal to (<=) -0.3 from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months before Screening

• Have a PASI greater than or equal to (>=) 12 at Screening and at Baseline

• Have an IGA >= 3 at Screening and at Baseline

• Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline

• Be a candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment)

Exclusion Criteria:

• Has a history of or current signs or symptoms of severe, progressive, or uncontrolled cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances

• Has unstable cardiovascular disease, defined as a recent clinical deterioration (example, unstable angina, atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months before Screening

• Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before Screening

• Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly

• Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Asahikawa		Japan
2		Chuo		Japan
3		Gifu		Japan
4		Isehara-city,		Japan
5		Izumo		Japan
6		Kanazawa		Japan
7		Kawasaki		Japan
8		Kita-Gun		Japan
9		Kochi		Japan
10		Kurume		Japan
11		Kyoto		Japan
12		Matsumoto		Japan
13		Miyagi		Japan
14		Morioka		Japan
15		Nagoya		Japan
16		Osaka-Sayama		Japan
17		Osaka		Japan
18		Sapporo		Japan
19		Shimotsuke		Japan
20		Shinjuku-ku		Japan
21		Tokushima		Japan
22		Tokyo		Japan
23		Toon		Japan
24		Tsukuba		Japan
25		Tsu		Japan
26		Ube		Japan
27		Yokosuka		Japan

Sponsors and Collaborators

• Janssen Pharmaceutical K.K.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) in the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis

Publications

None provided.

• Responsible Party: Janssen Pharmaceutical K.K.
• ClinicalTrials.gov Identifier: NCT02325219
• Other Study ID Numbers: CR103833; CNTO1959PSO3004
• First Posted: Dec 24, 2014
• Last Update Posted: May 22, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Janssen Pharmaceutical K.K.: Psoriasis; CNTO 1959; Guselkumab; Placebo
• Additional relevant MeSH terms: Psoriasis; Antibodies, Monoclonal

Study Results

Participant Flow

Arm/Group Title	Placebo (Controlled Period [CP])	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Period Title: Controlled Period (Week 0 - 16)
STARTED	64	65	63	0	0
COMPLETED	52	63	62	0	0
NOT COMPLETED	12	2	1	0	0
Period Title: Controlled Period (Week 0 - 16)
STARTED	0	63	62	26	26
COMPLETED	0	60	62	26	25
NOT COMPLETED	0	3	0	0	1

Baseline Characteristics

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Total
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Total of all reporting groups
Overall Participants	64	65	63	192
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.3 (10.56)	50.1 (12.66)	47.8 (11.07)	48.8 (11.46)
Sex: Female, Male (Count of Participants)
Female	10 15.6%	21 32.3%	16 25.4%	47 24.5%
Male	54 84.4%	44 67.7%	47 74.6%	145 75.5%
Region of Enrollment (Count of Participants)
Japan	64 100%	65 100%	63 100%	192 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
Description	The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	64	65	63
Number [percentage of participants]	7.8 12.2%	92.3 142%	88.9 141.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (CP), Guselkumab 50 mg (CP)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (CP), Guselkumab 100 mg (CP)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Fisher Exact
	Comments

2. Primary Outcome

Title	Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	64	65	63
Number [percentage of participants]	0 0%	70.8 108.9%	69.8 110.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (CP), Guselkumab 50 mg (CP)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (CP), Guselkumab 100 mg (CP)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI 75 Response at Week 16
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	64	65	63
Number [percentage of participants]	6.3 9.8%	89.2 137.2%	84.1 133.5%

4. Secondary Outcome

Title	Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
Description	The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	64	65	63
Mean (Standard Deviation) [units on a scale]	-0.8 (5.40)	-8.3 (5.87)	-8.5 (6.95)

5. Secondary Outcome

Title	Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Description	The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	64	65	63
Week 2: IGA 0 responders	0 0%	0 0%	0 0%
Week 2: IGA 0/1 responders	0 0%	3.1 4.8%	9.5 15.1%
Week 2: IGA 0/1/2 responders	10.9 17%	47.7 73.4%	46.0 73%
Week 4: IGA 0 responders	0 0%	1.5 2.3%	6.3 10%
Week 4: IGA 0/1 responders	1.6 2.5%	27.7 42.6%	25.4 40.3%
Week 4: IGA 0/1/2 responders	20.3 31.7%	81.5 125.4%	77.8 123.5%
Week 8: IGA 0 responders	0 0%	16.9 26%	20.6 32.7%
Week 8: IGA 0/1 responders	1.6 2.5%	76.9 118.3%	65.1 103.3%
Week 8: IGA 0/1/2 responders	20.3 31.7%	93.8 144.3%	93.7 148.7%
Week 12: IGA 0 responders	0 0%	33.8 52%	33.3 52.9%
Week 12: IGA 0/1 responders	4.7 7.3%	89.2 137.2%	84.1 133.5%
Week 12: IGA 0/1/2 responders	25.0 39.1%	95.4 146.8%	96.8 153.7%
Week 16: IGA 0 responders	0 0%	44.6 68.6%	44.4 70.5%
Week 16: IGA 0/1 responders	7.8 12.2%	92.3 142%	88.9 141.1%
Week 16: IGA 0/1/2 responders	28.1 43.9%	96.9 149.1%	96.8 153.7%

6. Secondary Outcome

Title	Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Description	The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame	Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52

Outcome Measure Data

Analysis Population Description

The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	65	63	26	26
Week 20: IGA 0 responders	46.2 72.2%	57.1 87.8%	3.8 6%	11.5 6%
Week 20: IGA 0/1 responders	89.2 139.4%	92.1 141.7%	57.7 91.6%	46.2 24.1%
Week 20: IGA 0/1/2 responders	96.9 151.4%	96.8 148.9%	84.6 134.3%	88.5 46.1%
Week 24: IGA 0 responders	53.8 84.1%	57.1 87.8%	15.4 24.4%	38.5 20.1%
Week 24: IGA 0/1 responders	90.8 141.9%	88.9 136.8%	88.5 140.5%	80.8 42.1%
Week 24: IGA 0/1/2 responders	98.5 153.9%	96.8 148.9%	96.2 152.7%	100.0 52.1%
Week 28: IGA 0 responders	53.8 84.1%	49.2 75.7%	50.0 79.4%	46.2 24.1%
Week 28: IGA 0/1 responders	90.8 141.9%	88.9 136.8%	100.0 158.7%	88.5 46.1%
Week 28: IGA 0/1/2 responders	98.5 153.9%	95.2 146.5%	100.0 158.7%	100.0 52.1%
Week 32: IGA 0 responders	47.7 74.5%	55.6 85.5%	53.8 85.4%	50.0 26%
Week 32: IGA 0/1 responders	89.2 139.4%	90.5 139.2%	100.0 158.7%	92.3 48.1%
Week 32: IGA 0/1/2 responders	98.5 153.9%	96.8 148.9%	100.0 158.7%	100.0 52.1%
Week 36: IGA 0 responders	44.6 69.7%	55.6 85.5%	61.5 97.6%	46.2 24.1%
Week 36: IGA 0/1 responders	89.2 139.4%	90.5 139.2%	100.0 158.7%	92.3 48.1%
Week 36: IGA 0/1/2 responders	98.5 153.9%	96.8 148.9%	100.0 158.7%	100.0 52.1%
Week 40: IGA 0 responders	49.2 76.9%	55.6 85.5%	65.4 103.8%	57.7 30.1%
Week 40: IGA 0/1 responders	87.7 137%	92.1 141.7%	100.0 158.7%	92.3 48.1%
Week 40: IGA 0/1/2 responders	96.9 151.4%	98.4 151.4%	100.0 158.7%	100.0 52.1%
Week 44: IGA 0 responders	55.4 86.6%	52.4 80.6%	61.5 97.6%	57.7 30.1%
Week 44: IGA 0/1 responders	86.2 134.7%	88.9 136.8%	100.0 158.7%	92.3 48.1%
Week 44: IGA 0/1/2 responders	98.5 153.9%	96.8 148.9%	100.0 158.7%	100.0 52.1%
Week 48: IGA 0 responders	50.8 79.4%	60.3 92.8%	73.1 116%	57.7 30.1%
Week 48: IGA 0/1 responders	86.2 134.7%	87.3 134.3%	100.0 158.7%	92.3 48.1%
Week 48: IGA 0/1/2 responders	98.5 153.9%	96.8 148.9%	100.0 158.7%	100.0 52.1%
Week 52: IGA 0 responders	53.8 84.1%	58.7 90.3%	53.8 85.4%	50.0 26%
Week 52: IGA 0/1 responders	87.7 137%	90.5 139.2%	100.0 158.7%	88.5 46.1%
Week 52: IGA 0/1/2 responders	98.5 153.9%	98.4 151.4%	100.0 158.7%	100.0 52.1%

7. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	64	65	63
Week 2: PASI 50 responders	0 0%	4.6 7.1%	17.5 27.8%
Week 2: PASI 75 responders	0 0%	0 0%	1.6 2.5%
Week 2: PASI 90 responders	0 0%	0 0%	0 0%
Week 2: PASI 100 responders	0 0%	0 0%	0 0%
Week 4: PASI 50 responders	1.6 2.5%	49.2 75.7%	49.2 78.1%
Week 4: PASI 75 responders	0 0%	15.4 23.7%	17.5 27.8%
Week 4: PASI 90 responders	0 0%	4.6 7.1%	4.8 7.6%
Week 4: PASI 100 responders	0 0%	1.5 2.3%	1.6 2.5%
Week 8: PASI 50 responders	9.4 14.7%	87.7 134.9%	79.4 126%
Week 8: PASI 75 responders	0 0%	55.4 85.2%	50.8 80.6%
Week 8: PASI 90 responders	0 0%	30.8 47.4%	30.2 47.9%
Week 8: PASI 100 responders	0 0%	7.7 11.8%	7.9 12.5%
Week 12: PASI 50 responders	7.8 12.2%	90.8 139.7%	92.1 146.2%
Week 12: PASI 75 responders	3.1 4.8%	78.5 120.8%	79.4 126%
Week 12: PASI 90 responders	0 0%	47.7 73.4%	38.1 60.5%
Week 12: PASI 100 responders	0 0%	16.9 26%	22.2 35.2%
Week 16: PASI 50 responders	14.1 22%	93.8 144.3%	95.2 151.1%
Week 16: PASI 75 responders	6.3 9.8%	89.2 137.2%	84.1 133.5%
Week 16: PASI 90 responders	0 0%	70.8 108.9%	69.8 110.8%
Week 16: PASI 100 responders	0 0%	32.3 49.7%	27.0 42.9%

8. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.
Time Frame	Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52

Outcome Measure Data

Analysis Population Description

The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	65	63	26	26
Week 20: PASI 50 responders	95.4 149.1%	96.8 148.9%	57.7 91.6%	65.4 34.1%
Week 20: PASI 75 responders	90.8 141.9%	88.9 136.8%	46.2 73.3%	30.8 16%
Week 20: PASI 90 responders	70.8 110.6%	71.4 109.8%	19.2 30.5%	15.4 8%
Week 20: PASI 100 responders	33.8 52.8%	34.9 53.7%	3.8 6%	0 0%
Week 24: PASI 50 responders	98.5 153.9%	98.4 151.4%	92.3 146.5%	84.6 44.1%
Week 24: PASI 75 responders	90.8 141.9%	90.5 139.2%	80.8 128.3%	61.5 32%
Week 24: PASI 90 responders	78.5 122.7%	76.2 117.2%	42.3 67.1%	46.2 24.1%
Week 24: PASI 100 responders	41.5 64.8%	44.4 68.3%	11.5 18.3%	23.1 12%
Week 28: PASI 50 responders	98.5 153.9%	98.4 151.4%	100.0 158.7%	92.3 48.1%
Week 28: PASI 75 responders	92.3 144.2%	90.5 139.2%	88.5 140.5%	80.8 42.1%
Week 28: PASI 90 responders	75.4 117.8%	77.8 119.7%	73.1 116%	61.5 32%
Week 28: PASI 100 responders	44.6 69.7%	38.1 58.6%	30.8 48.9%	34.6 18%
Week 32: PASI 50 responders	98.5 153.9%	98.4 151.4%	100.0 158.7%	96.2 50.1%
Week 32: PASI 75 responders	92.3 144.2%	90.5 139.2%	92.3 146.5%	84.6 44.1%
Week 32: PASI 90 responders	76.9 120.2%	76.2 117.2%	76.9 122.1%	69.2 36%
Week 32: PASI 100 responders	41.5 64.8%	44.4 68.3%	34.6 54.9%	38.5 20.1%
Week 36: PASI 50 responders	98.5 153.9%	95.2 146.5%	100.0 158.7%	96.2 50.1%
Week 36: PASI 75 responders	92.3 144.2%	90.5 139.2%	96.2 152.7%	92.3 48.1%
Week 36: PASI 90 responders	78.5 122.7%	76.2 117.2%	84.6 134.3%	65.4 34.1%
Week 36: PASI 100 responders	36.9 57.7%	42.9 66%	30.8 48.9%	42.3 22%
Week 40: PASI 50 responders	98.5 153.9%	98.4 151.4%	100.0 158.7%	96.2 50.1%
Week 40: PASI 75 responders	90.8 141.9%	90.5 139.2%	100.0 158.7%	92.3 48.1%
Week 40: PASI 90 responders	78.5 122.7%	77.8 119.7%	96.2 152.7%	73.1 38.1%
Week 40: PASI 100 responders	33.8 52.8%	44.4 68.3%	38.5 61.1%	50.0 26%
Week 44: PASI 50 responders	98.5 153.9%	95.2 146.5%	100.0 158.7%	96.2 50.1%
Week 44: PASI 75 responders	90.8 141.9%	88.9 136.8%	100.0 158.7%	92.3 48.1%
Week 44: PASI 90 responders	80.0 125%	74.6 114.8%	88.5 140.5%	73.1 38.1%
Week 44: PASI 100 responders	38.5 60.2%	44.4 68.3%	42.3 67.1%	50.0 26%
Week 48: PASI 50 responders	98.5 153.9%	96.8 148.9%	100.0 158.7%	96.2 50.1%
Week 48: PASI 75 responders	90.8 141.9%	93.7 144.2%	100.0 158.7%	92.3 48.1%
Week 48: PASI 90 responders	75.4 117.8%	77.8 119.7%	100.0 158.7%	76.9 40.1%
Week 48: PASI 100 responders	36.9 57.7%	49.2 75.7%	46.2 73.3%	42.3 22%
Week 52: PASI 50 responders	98.5 153.9%	98.4 151.4%	100.0 158.7%	96.2 50.1%
Week 52: PASI 75 responders	92.3 144.2%	90.5 139.2%	100.0 158.7%	92.3 48.1%
Week 52: PASI 90 responders	75.4 117.8%	77.8 119.7%	92.3 146.5%	73.1 38.1%
Week 52: PASI 100 responders	38.5 60.2%	47.6 73.2%	38.5 61.1%	42.3 22%

9. Secondary Outcome

Title	Percent Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Time Frame	Baseline and Weeks 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	64	65	63
Week 2	0.4 (18.55)	20.1 (20.85)	23.6 (23.76)
Week 4	0.0 (27.74)	45.3 (26.72)	44.9 (30.80)
Week 8	1.5 (32.73)	74.5 (22.39)	70.3 (25.42)
Week 12	0.5 (38.28)	83.7 (20.00)	82.9 (18.56)
Week 16	0.2 (45.53)	88.9 (17.34)	88.7 (17.77)

10. Secondary Outcome

Title	Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Time Frame	Baseline and Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52

Outcome Measure Data

Analysis Population Description

The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	65	63	26	26
Week 20	89.4 (18.21)	90.6 (16.45)	58.7 (33.67)	51.9 (39.06)
Week 24	91.6 (14.59)	92.1 (15.51)	80.7 (24.87)	78.8 (22.44)
Week 28	91.9 (14.05)	91.4 (16.24)	91.6 (10.81)	85.6 (20.60)
Week 32	92.5 (12.38)	92.0 (15.78)	93.1 (8.59)	89.1 (19.66)
Week 36	92.2 (13.42)	90.5 (19.40)	94.7 (6.76)	91.5 (13.84)
Week 40	92.3 (13.86)	92.1 (15.86)	96.4 (3.87)	92.3 (14.08)
Week 44	91.8 (17.30)	91.1 (17.26)	96.6 (4.39)	92.2 (14.28)
Week 48	91.5 (17.28)	92.1 (16.14)	97.9 (2.73)	91.8 (14.21)
Week 52	91.6 (17.12)	92.5 (15.39)	96.7 (4.45)	91.4 (14.02)

11. Secondary Outcome

Title	Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Time Frame	Baseline and Weeks 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	64	65	63
Week 2	0.0 (4.44)	-5.7 (7.13)	-6.3 (7.17)
Week 4	-0.2 (7.13)	-12.1 (10.55)	-12.5 (11.00)
Week 8	-1.0 (8.99)	-19.1 (10.62)	-19.2 (11.80)
Week 12	-0.6 (10.62)	-21.4 (11.11)	-22.4 (11.86)
Week 16	-0.5 (12.39)	-22.6 (11.00)	-23.9 (12.27)

12. Secondary Outcome

Title	Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Time Frame	Baseline and Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	65	63	26	26
Week 20	-22.8 (11.23)	-24.3 (12.52)	-18.3 (15.46)	-11.3 (10.33)
Week 24	-23.4 (11.16)	-24.7 (12.35)	-24.2 (15.12)	-18.2 (9.56)
Week 28	-23.6 (11.44)	-24.5 (12.56)	-27.0 (14.84)	-20.1 (10.52)
Week 32	-23.7 (11.30)	-24.7 (12.58)	-27.6 (15.02)	-21.0 (11.05)
Week 36	-23.6 (11.38)	-24.3 (12.72)	-28.0 (15.02)	-21.5 (10.37)
Week 40	-23.7 (11.51)	-24.6 (12.29)	-28.4 (14.96)	-21.7 (10.65)
Week 44	-23.5 (11.69)	-24.3 (12.29)	-28.5 (15.04)	-21.6 (10.55)
Week 48	-23.4 (11.59)	-24.6 (12.27)	-28.7 (14.90)	-21.6 (10.78)
Week 52	-23.5 (11.74)	-24.6 (12.11)	-28.5 (15.07)	-21.5 (10.62)

13. Secondary Outcome

Title	Change From Baseline in Body Surface Area (BSA) Involvement by Psoriatic Lesions at Week 48
Description	BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.
Time Frame	Baseline and Week 48

Outcome Measure Data

Analysis Population Description

The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	65	63	26	26
Mean (Standard Deviation) [Change in BSA (% points)]	-31.7 (22.40)	-34.4 (21.19)	-37.1 (22.24)	-27.7 (16.08)

14. Secondary Outcome

Title	Change From Baseline in Nail Psoriasis Area and Severity Index (NAPSI) Score at Week 16
Description	NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

Population included participants randomized at Week 0 and with nail psoriasis at baseline.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	42	44	40
Mean (Standard Deviation) [units on a scale]	-0.2 (1.13)	-1.2 (1.61)	-1.5 (1.78)

15. Secondary Outcome

Title	Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
Description	NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Time Frame	Baseline and Weeks 28, 36, 48, 52

Outcome Measure Data

Analysis Population Description

Population included participants randomized to Guselkumab at Week 0 or 16 and with nail psoriasis at baseline.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	44	40	15	18
Week 28	-2.2 (1.79)	-2.4 (2.34)	-1.7 (1.40)	-0.7 (1.13)
Week 36	-2.3 (2.01)	-2.7 (2.23)	-2.5 (1.77)	-1.2 (1.50)
Week 48	-2.7 (1.91)	-2.7 (2.44)	-3.3 (2.22)	-1.7 (1.75)
Week 52	-2.8 (1.94)	-2.7 (2.20)	-3.3 (2.34)	-1.4 (1.54)

16. Secondary Outcome

Title	Percent Change From Baseline in NAPSI Score at Week 16
Description	NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

Population included participants randomized at Week 0 and with nail psoriasis at baseline.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	42	44	40
Mean (Standard Deviation) [percent change]	1.0 (59.38)	31.6 (43.56)	39.1 (48.93)

17. Secondary Outcome

Title	Percent Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
Description	NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Time Frame	Baseline and Weeks 28, 36, 48, 52

Outcome Measure Data

Analysis Population Description

Population included participants randomized to Guselkumab at Week 0 or 16 and with nail psoriasis at baseline.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	44	40	15	18
Week 28	57.9 (42.99)	61.1 (43.15)	48.7 (38.77)	23.6 (49.69)
Week 36	59.6 (46.95)	67.4 (45.44)	69.9 (30.48)	38.4 (40.34)
Week 48	71.0 (37.11)	68.1 (49.01)	80.2 (23.06)	53.7 (42.99)
Week 52	74.4 (35.11)	75.3 (41.32)	79.2 (25.62)	44.9 (53.56)

18. Secondary Outcome

Title	Percentage of Participants With a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Week 16
Description	The percentage of participants with an ss-IGA score of absence of disease (0) or very mild disease (1) and at least a 2-grade improvement from Baseline at Week 16 among participants who had an ss-IGA score of >= 2 at baseline was evaluated. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Population included participants randomized at Week 0 and with baseline ss-IGA score >= 2.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	57	58	58
Number [percentage of participants]	10.5 16.4%	74.1 114%	82.8 131.4%

19. Secondary Outcome

Title	Percentage of Participants With an Ss-IGA Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Weeks 28, 48 and 52
Description	The percentage of participants with an ss-IGA score of absence of disease (0) or very mild disease (1) and at least a 2-grade improvement from Baseline at Week 16 among participants who had an ss-IGA score of >= 2 at baseline was evaluated. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Time Frame	Week 28, 48 and 52

Outcome Measure Data

Analysis Population Description

Population included participants randomized to Guselkumab at Week 0 or 16 and with baseline ss-IGA score >= 2.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	58	58	21	24
Week 28	86.2 134.7%	86.2 132.6%	90.5 143.7%	70.8 36.9%
Week 48	84.5 132%	84.5 130%	85.7 136%	83.3 43.4%
Week 52	84.5 132%	86.2 132.6%	85.7 136%	95.8 49.9%

20. Secondary Outcome

Title	Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 16
Description	The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Population included participants randomized at Week 0 and with baseline ss-IGA score >= 2.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	57	58	58
Absence of Disease (0)	3.5 5.5%	48.3 74.3%	63.8 101.3%
Very Mild Disease (1)	8.8 13.8%	41.4 63.7%	22.4 35.6%
Mild Disease (2)	21.1 33%	8.6 13.2%	8.6 13.7%
Moderate Disease (3)	49.1 76.7%	1.7 2.6%	5.2 8.3%
Severe Disease (4)	17.5 27.3%	0 0%	0 0%

21. Secondary Outcome

Title	Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Description	The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Time Frame	Week 28, 48 and 52

Outcome Measure Data

Analysis Population Description

Population included participants randomized to Guselkumab at Week 0 or 16 and with baseline ss-IGA score >= 2

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	58	58	21	24
Week 28: Absence of Disease (0)	63.8 99.7%	70.7 108.8%	66.7 105.9%	50.0 26%
Week 28: Very Mild Disease (1)	31.0 48.4%	22.4 34.5%	28.6 45.4%	25.0 13%
Week 28: Mild Disease (2)	3.4 5.3%	3.4 5.2%	4.8 7.6%	12.5 6.5%
Week 28: Moderate Disease (3)	1.7 2.7%	3.4 5.2%	0 0%	12.5 6.5%
Week 28: Severe Disease (4)	0 0%	0 0%	0 0%	0 0%
Week 48: Absence of Disease (0)	67.2 105%	75.9 116.8%	76.2 121%	66.7 34.7%
Week 48: Very Mild Disease (1)	25.9 40.5%	13.8 21.2%	9.5 15.1%	20.8 10.8%
Week 48: Mild Disease (2)	5.2 8.1%	6.9 10.6%	9.5 15.1%	12.5 6.5%
Week 48: Moderate Disease (3)	1.7 2.7%	3.4 5.2%	4.8 7.6%	0 0%
Week 48: Severe Disease (4)	0 0%	0 0%	0 0%	0 0%
Week 52: Absence of Disease (0)	67.2 105%	77.6 119.4%	66.7 105.9%	75.0 39.1%
Week 52: Very Mild Disease (1)	27.6 43.1%	10.3 15.8%	19.0 30.2%	20.8 10.8%
Week 52: Mild Disease (2)	3.4 5.3%	10.3 15.8%	14.3 22.7%	4.2 2.2%
Week 52: Moderate Disease (3)	1.7 2.7%	1.7 2.6%	0 0%	0 0%
Week 52: Severe Disease (4)	0 0%	0 0%	0 0%	0 0%

22. Secondary Outcome

Title	Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 8 and 16
Description	The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Time Frame	Weeks 8 and 16

Outcome Measure Data

Analysis Population Description

Population included participants randomized at Week 0 and with baseline DLQI > 1.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	61	64	60
Week 8	6.6 10.3%	43.8 67.4%	43.3 68.7%
Week 16	6.6 10.3%	64.1 98.6%	68.3 108.4%

23. Secondary Outcome

Title	Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 28, 36, 48, and 52
Description	The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Time Frame	Weeks 28, 36, 48, and 52

Outcome Measure Data

Analysis Population Description

Population included participants randomized to Guselkumab at Week 0 or 16 and with baseline DLQI <=1.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	64	60	24	25
Week 28	70.3 109.8%	75.0 115.4%	50.0 79.4%	68.0 35.4%
Week 36	79.7 124.5%	83.3 128.2%	79.2 125.7%	68.0 35.4%
Week 48	73.4 114.7%	73.3 112.8%	62.5 99.2%	72.0 37.5%
Week 52	73.4 114.7%	76.7 118%	75.0 119%	80.0 41.7%

24. Secondary Outcome

Title	Change From Baseline in the DLQI Total Score at Week 8
Description	The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Time Frame	Baseline and Weeks 8

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	64	65	63
Mean (Standard Deviation) [units on a scale]	-0.4 (4.71)	-7.5 (5.28)	-7.0 (6.35)

25. Secondary Outcome

Title	Change From Baseline in the DLQI Total Score at Weeks 28, 36, 48, 52
Description	The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Time Frame	Baseline and Weeks 28, 36, 48, 52

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	65	63	26	26
Week 28	-9.0 (5.85)	-8.9 (6.95)	-9.5 (7.73)	-5.5 (5.19)
Week 36	-9.2 (6.44)	-9.2 (7.27)	-10.3 (8.01)	-6.1 (5.99)
Week 48	-9.2 (6.20)	-9.1 (7.12)	-10.1 (7.94)	-6.1 (5.82)
Week 52	-9.2 (6.39)	-9.0 (7.28)	-10.1 (7.79)	-6.5 (5.05)

26. Secondary Outcome

Title	Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 8 and 16
Description	The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Time Frame	Weeks 8 and 16

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	64	65	63
Week 8	17.2 26.9%	61.5 94.6%	58.7 93.2%
Week 16	20.3 31.7%	67.7 104.2%	69.8 110.8%

27. Secondary Outcome

Title	Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 28, 36, 48, and 52
Description	The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Time Frame	Weeks 28, 36, 48, and 52

Outcome Measure Data

Analysis Population Description

The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	65	63	26	26
Week 28	69.2 108.1%	73.0 112.3%	65.4 103.8%	57.7 30.1%
Week 36	72.3 113%	68.3 105.1%	69.2 109.8%	57.7 30.1%
Week 48	72.3 113%	71.4 109.8%	69.2 109.8%	61.5 32%
Week 52	72.3 113%	71.4 109.8%	69.2 109.8%	61.5 32%

28. Secondary Outcome

Title	Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Week 16
Description	The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	64	65	63
Mean (Standard Deviation) [units on a scale]	0.05 (0.141)	0.20 (0.199)	0.18 (0.210)

29. Secondary Outcome

Title	Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Weeks 28 and 48
Description	The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame	Baseline and Weeks 28, 48

Outcome Measure Data

Analysis Population Description

The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	65	63	26	26
Week 28	0.20 (0.187)	0.20 (0.221)	0.25 (0.170)	0.14 (0.133)
Week 48	0.20 (0.198)	0.21 (0.228)	0.28 (0.152)	0.15 (0.140)

30. Secondary Outcome

Title	Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 16
Description	The EQ visual analog scale (EQ VAS) is the part of EQ-5D scale. The EQ VAS records the respondent's self-rated health on a vertical, visual analog scale where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0).
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	64	65	63
Mean (Standard Deviation) [units on a scale]	2.45 (22.440)	21.20 (23.542)	18.43 (26.206)

31. Secondary Outcome

Title	Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Weeks 28, 48
Description	The EQ visual analog scale (EQ VAS) is the part of EQ-5D scale. The EQ VAS records the respondent's self-rated health on a vertical, visual analog scale where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0).
Time Frame	Baseline and Weeks 28, 48

Outcome Measure Data

Analysis Population Description

The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	65	63	26	26
Week 28	22.94 (24.759)	20.87 (26.465)	20.73 (20.095)	11.62 (26.831)
Week 48	20.88 (29.647)	21.70 (26.577)	20.38 (22.094)	7.00 (29.490)

32. Secondary Outcome

Title	Change From Baseline in the Physical and Mental Component Summary (PCS and MCS) Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Week 16
Description	SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	64	65	63
PCS	0.3 (9.90)	7.4 (15.65)	7.3 (14.40)
MCS	1.3 (8.21)	4.0 (7.22)	5.3 (9.63)

33. Secondary Outcome

Title	Change From Baseline in the PCS and MCS Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 28 and 48
Description	SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.
Time Frame	Baseline and Weeks 28, 48

Outcome Measure Data

Analysis Population Description

The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	65	63	26	26
Week 28: PCS	7.7 (13.71)	8.9 (14.83)	6.4 (10.20)	5.4 (9.80)
Week 48: PCS	8.2 (14.22)	8.4 (15.16)	8.8 (12.13)	4.4 (7.60)
Week 28: MCS	5.9 (9.62)	4.6 (10.30)	6.5 (6.91)	4.9 (9.83)
Week 48: MCS	5.7 (9.04)	5.6 (9.32)	4.5 (9.92)	5.0 (11.00)

34. Secondary Outcome

Title	Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Week 16
Description	Changes from baseline in the 4 types (absenteeism, activity impairment, presenteeism, and Work productivity loss) of WPAI scores at Week 16 were evaluated. The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment. Here 'n' (number analyzed) signifies the number of participants analyzed for specified category.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	64	65	63
Absenteeism	0.9 (14.96)	-2.4 (8.14)	-1.9 (8.18)
Activity Impairment	-7.7 (24.09)	-30.9 (31.95)	-33.8 (33.91)
Presenteeism	-7.2 (22.62)	-22.0 (34.06)	-23.7 (30.92)
Work Productivity Loss	-7.6 (23.24)	-23.0 (34.38)	-24.1 (31.79)

35. Secondary Outcome

Title	Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48
Description	Changes from baseline in the 4 types (absenteeism, activity impairment, presenteeism, and Work productivity loss) of WPAI scores at Weeks 28 and 48 were evaluated. The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.
Time Frame	Baseline and Weeks 28, 48

Outcome Measure Data

Analysis Population Description

The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment. Here 'n' signifies the number of participants analyzed for specified category.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	65	63	26	26
Week 28: Absenteeism	-3.0 (10.93)	-2.8 (9.12)	-4.0 (8.78)	-0.1 (2.03)
Week 28: Activity Impairment	-35.1 (32.02)	-33.5 (32.19)	-32.7 (29.20)	-28.1 (28.85)
Week 28: Presenteeism	-26.9 (30.83)	-24.5 (34.43)	-27.1 (25.62)	-18.7 (26.85)
Week 28: Work Productivity Loss	-28.1 (31.18)	-25.1 (35.05)	-28.3 (26.61)	-18.3 (26.68)
Week 48: Absenteeism	-2.0 (6.56)	-2.9 (9.37)	-4.5 (9.02)	0.7 (2.49)
Week 48: Activity Impairment	-38.0 (30.58)	-36.8 (31.72)	-36.2 (28.44)	-25.0 (30.50)
Week 48: Presenteeism	-29.3 (31.25)	-30.8 (30.97)	-30.0 (29.93)	-20.4 (27.88)
Week 48: Work Productivity Loss	-29.6 (31.88)	-31.4 (31.71)	-31.5 (30.93)	-19.2 (27.84)

36. Secondary Outcome

Title	Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16
Description	ACR Response is defined as percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in swollen joint (66 joints) and tender joint (68 joints) counts and percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in 3 of following 5 assessments: patient's assessment of pain using VAS (VAS; 0-10, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity by using VAS (scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Time Frame	Weeks 4, 8, and 16

Outcome Measure Data

Analysis Population Description

Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	10	11	10
Week 4: ACR 20 responders	0 0%	27.3 42%	10.0 15.9%
Week 4: ACR 50 responders	0 0%	18.2 28%	0 0%
Week 4: ACR 70 responders	0 0%	9.1 14%	0 0%
Week 8: ACR 20 responders	10.0 15.6%	45.5 70%	20.0 31.7%
Week 8: ACR 50 responders	0 0%	36.4 56%	20.0 31.7%
Week 8: ACR 70 responders	0 0%	18.2 28%	0 0%
Week 16: ACR 20 responders	0 0%	45.5 70%	30.0 47.6%
Week 16: ACR 50 responders	0 0%	18.2 28%	30.0 47.6%
Week 16: ACR 70 responders	0 0%	9.1 14%	30.0 47.6%

37. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
Description	ACR Response is defined as percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in swollen joint (66 joints) and tender joint (68 joints) counts and percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in 3 of following 5 assessments: patient's assessment of pain using VAS (VAS; 0-10, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity by using VAS (scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Time Frame	Weeks 28, 36, 48, and 52

Outcome Measure Data

Analysis Population Description

Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	11	10	3	4
Week 28: ACR 20 responders	36.4 56.9%	40.0 61.5%	66.7 105.9%	0 0%
Week 28: ACR 50 responders	27.3 42.7%	40.0 61.5%	33.3 52.9%	0 0%
Week 28: ACR 70 responders	18.2 28.4%	30.0 46.2%	33.3 52.9%	0 0%
Week 36: ACR 20 responders	45.5 71.1%	40.0 61.5%	66.7 105.9%	50.0 26%
Week 36: ACR 50 responders	36.4 56.9%	40.0 61.5%	66.7 105.9%	25.0 13%
Week 36: ACR 70 responders	27.3 42.7%	40.0 61.5%	33.3 52.9%	0 0%
Week 48: ACR 20 responders	45.5 71.1%	30.0 46.2%	66.7 105.9%	25.0 13%
Week 48: ACR 50 responders	45.5 71.1%	30.0 46.2%	66.7 105.9%	25.0 13%
Week 48: ACR 70 responders	36.4 56.9%	30.0 46.2%	66.7 105.9%	0 0%
Week 52: ACR 20 responders	54.5 85.2%	20.0 30.8%	66.7 105.9%	50.0 26%
Week 52: ACR 50 responders	36.4 56.9%	20.0 30.8%	66.7 105.9%	50.0 26%
Week 52: ACR 70 responders	27.3 42.7%	20.0 30.8%	66.7 105.9%	0 0%

38. Secondary Outcome

Title	Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Description	Percent change from baseline in the tender joints and swollen joints counts at Weeks 4, 8, and 16 was evaluated.
Time Frame	Weeks 4, 8, and 16

Outcome Measure Data

Analysis Population Description

Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening. Here 'n' (number analyzed) signifies the number of participants analyzed for specified category.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	10	11	10
Week 4: Tender joints	-7.4 (22.22)	41.1 (34.47)	-8.8 (117.56)
Week 4: Swollen joints	14.1 (35.00)	20.5 (39.50)	22.2 (32.77)
Week 8: Tender joints	-54.6 (188.70)	47.3 (39.61)	50.1 (58.06)
Week 8: Swollen joints	29.5 (39.76)	56.0 (42.33)	50.0 (40.82)
Week 16: Tender joints	-60.2 (86.58)	47.0 (40.12)	22.7 (126.76)
Week 16: Swollen joints	22.7 (52.66)	55.7 (46.71)	79.2 (40.05)

39. Secondary Outcome

Title	Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Description	Percent change from baseline in the tender joints and swollen joints counts at Weeks 28, 36, 48 and 52 was evaluated.
Time Frame	Weeks 28, 36, 48, and 52

Outcome Measure Data

Analysis Population Description

Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here 'n' signifies the number of participants analyzed for specified category.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	11	10	3	4
Week 28: Tender joints	54.9 (41.34)	60.6 (46.80)	33.3 (76.38)	-100.0 (81.65)
Week 28: Swollen joint	66.0 (39.14)	94.4 (8.61)	66.1 (29.36)	43.3 (60.28)
Week 36: Tender joints	69.7 (40.66)	62.1 (47.33)	33.3 (76.38)	25.0 (95.74)
Week 36: Swollen joint	55.2 (64.82)	94.4 (13.61)	84.7 (16.84)	63.3 (32.15)
Week 48: Tender joints	53.9 (61.03)	45.4 (73.14)	50.0 (86.60)	25.0 (95.74)
Week 48: Swollen joint	72.4 (42.84)	80.6 (34.02)	82.8 (13.98)	70.0 (26.46)
Week 52: Tender joints	67.8 (47.31)	32.9 (72.40)	66.7 (57.74)	75.0 (50.00)
Week 52: Swollen joint	84.5 (32.70)	58.3 (55.53)	88.9 (19.25)	86.7 (23.09)

40. Secondary Outcome

Title	Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Description	Change from baseline in the tender joints and swollen joints counts at Weeks 4, 8, and 16 was evaluated.
Time Frame	Baseline and Weeks 4, 8, 16

Outcome Measure Data

Analysis Population Description

Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	10	11	10
Week 4: Tender joints	0.2 (0.63)	-3.8 (6.15)	-1.6 (4.74)
Week 4: Swollen joints	-0.4 (0.97)	-1.2 (2.44)	-0.4 (1.58)
Week 8: Tender joints	0.9 (3.38)	-4.9 (9.24)	-2.6 (4.79)
Week 8: Swollen joints	-1.9 (4.68)	-2.1 (2.55)	-2.2 (3.43)
Week 16: Tender joints	1.3 (2.06)	-3.9 (6.32)	-3.3 (5.17)
Week 16: Swollen joints	-1.3 (3.56)	-2.3 (3.41)	-3.2 (4.37)

41. Secondary Outcome

Title	Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Description	Change from baseline in the tender joints and swollen joints counts at Weeks 28, 36, 48 and 52 was evaluated.
Time Frame	Baseline and Weeks 28, 36, 48, 52

Outcome Measure Data

Analysis Population Description

Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here 'n' signifies the number of participants analyzed for specified category.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	11	10	3	4
Week 28: Tender joints	-4.0 (6.03)	-4.1 (5.93)	-1.0 (2.00)	1.8 (1.71)
Week 28: Swollen joint	-2.5 (2.81)	-3.4 (4.35)	-9.7 (8.02)	-0.3 (0.96)
Week 36: Tender joints	-3.8 (6.23)	-4.0 (5.08)	-1.0 (2.00)	-1.0 (2.16)
Week 36: Swollen joint	-2.8 (3.46)	-3.6 (4.79)	-11.7 (8.62)	-1.0 (0.82)
Week 48: Tender joints	-3.3 (7.18)	-3.0 (4.83)	-1.3 (2.08)	-1.0 (2.16)
Week 48: Swollen joint	-2.9 (3.30)	-2.5 (3.87)	-11.7 (9.29)	-1.3 (1.26)
Week 52: Tender joints	-7.0 (11.19)	-2.9 (4.58)	-1.7 (1.53)	-1.5 (1.73)
Week 52: Swollen joint	-3.2 (3.43)	-1.5 (4.09)	-12.7 (10.26)	-1.5 (1.29)

42. Secondary Outcome

Title	Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 4, 8, 16
Description	Percent change from baseline in Patient's Assessment of Pain (VAS) among participants who had a diagnosis of PsA at screening at Weeks 4, 8 and 16 was evaluated. Each participant assessed his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 millimeter (mm) (no pain) to 100 mm (the worst pain imaginable).
Time Frame	Baseline and Weeks 4, 8, 16

Outcome Measure Data

Analysis Population Description

Population included randomized participants at Week 0 and who had diagnosis of PsA at screening. Participants were analyzed according to assigned treatment they were randomized to, regardless of treatment they actually received. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	10	11	7
Week 4	13.70 (23.698)	3.99 (78.918)	10.32 (118.053)
Week 8	2.36 (37.869)	38.19 (43.951)	45.15 (55.679)
Week 16	-0.73 (33.066)	45.51 (34.419)	62.11 (41.719)

43. Secondary Outcome

Title	Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 28, 36, 48, 52
Description	Percent change from baseline in Patient's Assessment of Pain (VAS) among participants who had a diagnosis of PsA at screening at Weeks 28, 36, 48 and 52 was evaluated. Each participant assessed his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).
Time Frame	Baseline and Weeks 28, 36, 48, 52

Outcome Measure Data

Analysis Population Description

Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	11	7	3	4
Week 28	-37.67 (339.724)	73.28 (28.687)	51.18 (30.418)	40.96 (73.340)
Week 36	-26.65 (273.745)	68.21 (40.538)	71.92 (21.156)	47.37 (46.079)
Week 48	50.38 (74.874)	57.65 (34.861)	81.36 (12.019)	74.08 (14.330)
Week 52	-30.54 (305.279)	62.09 (40.678)	77.06 (23.487)	61.47 (67.467)

44. Secondary Outcome

Title	Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 4, 8, 16
Description	The participant's and physician's global assessments of disease activity were recorded on a VAS. The VAS for the participant's assessment ranges from "very well" (0 centimeter [cm]) to "very poor" (10 cm).
Time Frame	Baseline and Weeks 4, 8, 16

Outcome Measure Data

Analysis Population Description

Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	10	11	6
Week 4	12.55 (24.547)	39.64 (38.514)	58.81 (29.281)
Week 8	2.50 (34.402)	44.50 (39.328)	63.10 (42.085)
Week 16	-6.52 (28.037)	21.38 (71.545)	75.70 (34.106)

45. Secondary Outcome

Title	Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 28, 36, 48, and 52
Description	The participant's and physician's global assessments of disease activity were recorded on a VAS. The VAS for the participant's assessment ranges from "very well" (0 cm) to "very poor" (10 cm).
Time Frame	Baseline and Weeks 28, 36, 48, 52

Outcome Measure Data

Analysis Population Description

Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	11	6	3	4
Week 28	-46.83 (346.499)	71.26 (35.552)	45.85 (35.019)	61.23 (16.062)
Week 36	-48.87 (341.563)	75.55 (33.992)	51.95 (27.007)	54.46 (27.386)
Week 48	43.09 (109.254)	58.36 (41.137)	76.02 (24.470)	67.60 (20.616)
Week 52	-20.17 (298.482)	66.00 (36.151)	71.59 (34.140)	69.10 (47.796)

46. Secondary Outcome

Title	Percentage of Participants Who Achieved Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Weeks 4, 8 and 16
Description	HAQ-DI response was defined as change of less than or equal to (<=) -0.3 from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning).
Time Frame	Weeks 4, 8, and 16

Outcome Measure Data

Analysis Population Description

Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening.

Arm/Group Title	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Measure Participants	10	11	10
Week 4	10.0 15.6%	36.4 56%	10.0 15.9%
Week 8	20.0 31.3%	45.5 70%	20.0 31.7%
Week 16	0 0%	54.5 83.8%	30.0 47.6%

47. Secondary Outcome

Title	Percentage of Participants Who Achieved HAQ-DI Response at Weeks 28, 36, 48, 52
Description	HAQ-DI response was defined as change of less than or equal to (<=) -0.3 from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning).
Time Frame	Weeks 28, 36, 48, 52

Outcome Measure Data

Analysis Population Description

Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening.

Arm/Group Title	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Placebo to Guselkumab 50 mg (After CP)	Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.	Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.	Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Measure Participants	11	10	3	4
Week 28	45.5 71.1%	30.0 46.2%	66.7 105.9%	25.0 13%
Week 36	54.5 85.2%	30.0 46.2%	66.7 105.9%	0 0%
Week 48	45.5 71.1%	20.0 30.8%	66.7 105.9%	25.0 13%
Week 52	45.5 71.1%	10.0 15.4%	66.7 105.9%	25.0 13%

Adverse Events

Time Frame	Up to Week 52
Adverse Event Reporting Description	The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
Arm/Group Title	Placebo (CP)		Guselkumab 50 mg (CP)		Guselkumab 100 mg (CP)		Guselkumab 50 mg (After CP)		Guselkumab 100 mg (After CP)		Placebo to Guselkumab 50 mg (After CP)		Placebo to Guselkumab 100 mg (After CP)
Arm/Group Description	Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).		Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12.		Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12.		Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44.		Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44.		Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.		Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
All Cause Mortality
	Placebo (CP)		Guselkumab 50 mg (CP)		Guselkumab 100 mg (CP)		Guselkumab 50 mg (After CP)		Guselkumab 100 mg (After CP)		Placebo to Guselkumab 50 mg (After CP)		Placebo to Guselkumab 100 mg (After CP)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo (CP)		Guselkumab 50 mg (CP)		Guselkumab 100 mg (CP)		Guselkumab 50 mg (After CP)		Guselkumab 100 mg (After CP)		Placebo to Guselkumab 50 mg (After CP)		Placebo to Guselkumab 100 mg (After CP)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/64 (3.1%)		1/65 (1.5%)		1/63 (1.6%)		6/63 (9.5%)		6/62 (9.7%)		4/26 (15.4%)		5/26 (19.2%)
Cardiac disorders
Angina Pectoris	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Atrial Fibrillation	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Cardiac Failure Congestive	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Eye disorders
Cataract	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Diabetic Retinopathy	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Glaucoma	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Macular Hole	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Rhegmatogenous Retinal Detachment	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Vitreous Haemorrhage	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Gastrointestinal disorders
Gastric Perforation	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Gastric Ulcer Haemorrhage	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Inguinal Hernia	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Large Intestine Polyp	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		0/26 (0%)		1/26 (3.8%)
Hepatobiliary disorders
Cholecystitis Acute	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Infections and infestations
Bacteraemia	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		0/26 (0%)		0/26 (0%)
Bacterial Prostatitis	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Cellulitis	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		0/26 (0%)		0/26 (0%)
Pancreatic Abscess	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Pyelonephritis	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		0/26 (0%)		0/26 (0%)
Injury, poisoning and procedural complications
Wrist Fracture	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Metabolism and nutrition disorders
Hyperkalaemia	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Musculoskeletal and connective tissue disorders
Gouty Tophus	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		0/26 (0%)		0/26 (0%)
Intervertebral Disc Protrusion	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma	0/64 (0%)		1/65 (1.5%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Colon Cancer	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Metastases to the Mediastinum	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Rectal Adenocarcinoma	0/64 (0%)		1/65 (1.5%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Nervous system disorders
Cerebral Infarction	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		1/62 (1.6%)		0/26 (0%)		0/26 (0%)
Loss of Consciousness	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Myelopathy	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Seizure	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Thalamus Haemorrhage	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Skin and subcutaneous tissue disorders
Pemphigoid	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Psoriasis	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Vascular disorders
Varicose Vein	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		0/26 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Placebo (CP)		Guselkumab 50 mg (CP)		Guselkumab 100 mg (CP)		Guselkumab 50 mg (After CP)		Guselkumab 100 mg (After CP)		Placebo to Guselkumab 50 mg (After CP)		Placebo to Guselkumab 100 mg (After CP)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/64 (56.3%)		27/65 (41.5%)		26/63 (41.3%)		56/63 (88.9%)		55/62 (88.7%)		25/26 (96.2%)		26/26 (100%)
Blood and lymphatic system disorders
Anaemia	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		2/62 (3.2%)		3/26 (11.5%)		0/26 (0%)
Neutropenia	0/64 (0%)		1/65 (1.5%)		0/63 (0%)		2/63 (3.2%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Cardiac disorders
Bradycardia	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Palpitations	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		1/62 (1.6%)		0/26 (0%)		0/26 (0%)
Tachycardia	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		1/26 (3.8%)		0/26 (0%)
Congenital, familial and genetic disorders
Dermoid Cyst	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Ear and labyrinth disorders
External Ear Inflammation	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Vertigo	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		2/62 (3.2%)		0/26 (0%)		0/26 (0%)
Eye disorders
Blepharitis	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		2/26 (7.7%)
Conjunctivitis Allergic	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		2/62 (3.2%)		0/26 (0%)		1/26 (3.8%)
Corneal Disorder	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Visual Impairment	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Gastrointestinal disorders
Abdominal Discomfort	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Abdominal Pain Lower	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Abdominal Pain Upper	1/64 (1.6%)		0/65 (0%)		1/63 (1.6%)		4/63 (6.3%)		4/62 (6.5%)		0/26 (0%)		1/26 (3.8%)
Constipation	0/64 (0%)		2/65 (3.1%)		1/63 (1.6%)		1/63 (1.6%)		1/62 (1.6%)		0/26 (0%)		3/26 (11.5%)
Dental Caries	1/64 (1.6%)		1/65 (1.5%)		2/63 (3.2%)		4/63 (6.3%)		5/62 (8.1%)		6/26 (23.1%)		2/26 (7.7%)
Diarrhoea	1/64 (1.6%)		1/65 (1.5%)		1/63 (1.6%)		7/63 (11.1%)		2/62 (3.2%)		2/26 (7.7%)		2/26 (7.7%)
Gastric Polyps	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		1/26 (3.8%)
Gastritis	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		0/62 (0%)		0/26 (0%)		2/26 (7.7%)
Gastrooesophageal Reflux Disease	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		0/62 (0%)		2/26 (7.7%)		0/26 (0%)
Haematochezia	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		2/62 (3.2%)		1/26 (3.8%)		0/26 (0%)
Haemorrhoids	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		2/26 (7.7%)
Large Intestine Polyp	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Nausea	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		2/63 (3.2%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Pancreatic Cyst	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		1/26 (3.8%)		0/26 (0%)
Pancreatitis Chronic	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Toothache	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Vomiting	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
General disorders
Injection Site Discolouration	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Injection Site Erythema	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		5/63 (7.9%)		7/62 (11.3%)		3/26 (11.5%)		4/26 (15.4%)
Injection Site Hypertrichosis	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Injection Site Hypertrophy	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Injection Site Induration	0/64 (0%)		0/65 (0%)		0/63 (0%)		3/63 (4.8%)		2/62 (3.2%)		0/26 (0%)		1/26 (3.8%)
Injection Site Pain	0/64 (0%)		0/65 (0%)		0/63 (0%)		3/63 (4.8%)		1/62 (1.6%)		0/26 (0%)		0/26 (0%)
Injection Site Pruritus	0/64 (0%)		0/65 (0%)		0/63 (0%)		4/63 (6.3%)		3/62 (4.8%)		0/26 (0%)		0/26 (0%)
Injection Site Swelling	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		3/62 (4.8%)		0/26 (0%)		1/26 (3.8%)
Pyrexia	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		1/62 (1.6%)		2/26 (7.7%)		3/26 (11.5%)
Hepatobiliary disorders
Hepatic Function Abnormal	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		1/63 (1.6%)		4/62 (6.5%)		1/26 (3.8%)		2/26 (7.7%)
Hepatic Steatosis	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		2/62 (3.2%)		1/26 (3.8%)		2/26 (7.7%)
Hepatitis Alcoholic	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Immune system disorders
Seasonal Allergy	0/64 (0%)		1/65 (1.5%)		0/63 (0%)		1/63 (1.6%)		3/62 (4.8%)		0/26 (0%)		0/26 (0%)
Infections and infestations
Body Tinea	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Bronchitis	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		5/62 (8.1%)		0/26 (0%)		6/26 (23.1%)
Cellulitis	1/64 (1.6%)		1/65 (1.5%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Conjunctivitis	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		1/62 (1.6%)		1/26 (3.8%)		1/26 (3.8%)
Cystitis	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		0/26 (0%)		2/26 (7.7%)
Diarrhoea Infectious	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Folliculitis	0/64 (0%)		2/65 (3.1%)		0/63 (0%)		1/63 (1.6%)		3/62 (4.8%)		1/26 (3.8%)		0/26 (0%)
Gastroenteritis	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		2/63 (3.2%)		2/62 (3.2%)		1/26 (3.8%)		1/26 (3.8%)
Gastroenteritis Viral	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Gingivitis	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		2/62 (3.2%)		0/26 (0%)		0/26 (0%)
Groin Abscess	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Helicobacter Infection	0/64 (0%)		2/65 (3.1%)		0/63 (0%)		2/63 (3.2%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Herpes Zoster	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		1/26 (3.8%)
Hordeolum	0/64 (0%)		2/65 (3.1%)		0/63 (0%)		1/63 (1.6%)		3/62 (4.8%)		0/26 (0%)		0/26 (0%)
Infectious Colitis	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Influenza	1/64 (1.6%)		1/65 (1.5%)		0/63 (0%)		9/63 (14.3%)		3/62 (4.8%)		5/26 (19.2%)		5/26 (19.2%)
Lice Infestation	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Nasopharyngitis	7/64 (10.9%)		14/65 (21.5%)		8/63 (12.7%)		38/63 (60.3%)		31/62 (50%)		14/26 (53.8%)		14/26 (53.8%)
Omphalitis	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Oral Herpes	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		1/62 (1.6%)		1/26 (3.8%)		0/26 (0%)
Paronychia	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Periodontitis	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Pharyngitis	1/64 (1.6%)		2/65 (3.1%)		0/63 (0%)		5/63 (7.9%)		5/62 (8.1%)		1/26 (3.8%)		1/26 (3.8%)
Pneumonia	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Rhinitis	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Tinea Cruris	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Tinea Pedis	0/64 (0%)		0/65 (0%)		0/63 (0%)		5/63 (7.9%)		1/62 (1.6%)		1/26 (3.8%)		1/26 (3.8%)
Tonsillitis	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Upper Respiratory Tract Infection	1/64 (1.6%)		1/65 (1.5%)		2/63 (3.2%)		2/63 (3.2%)		4/62 (6.5%)		1/26 (3.8%)		2/26 (7.7%)
Injury, poisoning and procedural complications
Arthropod Bite	1/64 (1.6%)		0/65 (0%)		1/63 (1.6%)		2/63 (3.2%)		1/62 (1.6%)		0/26 (0%)		2/26 (7.7%)
Contusion	0/64 (0%)		0/65 (0%)		0/63 (0%)		5/63 (7.9%)		1/62 (1.6%)		0/26 (0%)		1/26 (3.8%)
Face Injury	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		0/26 (0%)		1/26 (3.8%)
Hand Fracture	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Head Injury	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Joint Injury	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Ligament Sprain	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		2/62 (3.2%)		0/26 (0%)		0/26 (0%)
Muscle Strain	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		2/26 (7.7%)
Nerve Injury	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Post-Traumatic Neck Syndrome	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Rib Fracture	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		1/26 (3.8%)
Skin Abrasion	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		3/62 (4.8%)		0/26 (0%)		0/26 (0%)
Skin Laceration	0/64 (0%)		1/65 (1.5%)		1/63 (1.6%)		1/63 (1.6%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Thermal Burn	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		1/63 (1.6%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Tooth Fracture	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		0/63 (0%)		2/62 (3.2%)		0/26 (0%)		0/26 (0%)
Wound Complication	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Investigations
Alanine Aminotransferase Increased	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		1/62 (1.6%)		0/26 (0%)		0/26 (0%)
Aspartate Aminotransferase Increased	0/64 (0%)		0/65 (0%)		0/63 (0%)		3/63 (4.8%)		1/62 (1.6%)		0/26 (0%)		0/26 (0%)
Blood Bilirubin Increased	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		1/62 (1.6%)		0/26 (0%)		1/26 (3.8%)
Blood Creatinine Increased	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Blood Triglycerides Increased	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
C-Reactive Protein Increased	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		2/62 (3.2%)		0/26 (0%)		0/26 (0%)
Electrocardiogram Abnormal	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Electrocardiogram QT Prolonged	2/64 (3.1%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Hepatic Enzyme Increased	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		1/63 (1.6%)		1/62 (1.6%)		0/26 (0%)		1/26 (3.8%)
Liver Function Test Abnormal	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Neutrophil Count Decreased	0/64 (0%)		1/65 (1.5%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		1/26 (3.8%)		1/26 (3.8%)
Platelet Count Decreased	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		0/26 (0%)		1/26 (3.8%)
Weight Increased	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Metabolism and nutrition disorders
Diabetes Mellitus	1/64 (1.6%)		1/65 (1.5%)		0/63 (0%)		1/63 (1.6%)		6/62 (9.7%)		0/26 (0%)		4/26 (15.4%)
Dyslipidaemia	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		0/26 (0%)		3/26 (11.5%)
Gout	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		2/62 (3.2%)		0/26 (0%)		0/26 (0%)
Hyperkalaemia	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Hyperlipidaemia	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		1/62 (1.6%)		3/26 (11.5%)		1/26 (3.8%)
Hypertriglyceridaemia	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		2/62 (3.2%)		0/26 (0%)		0/26 (0%)
Hyperuricaemia	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		2/26 (7.7%)
Hypokalaemia	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Metabolic Disorder	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/64 (0%)		2/65 (3.1%)		1/63 (1.6%)		9/63 (14.3%)		6/62 (9.7%)		1/26 (3.8%)		2/26 (7.7%)
Back Pain	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		7/63 (11.1%)		6/62 (9.7%)		2/26 (7.7%)		1/26 (3.8%)
Joint Swelling	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Lumbar Spinal Stenosis	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		0/62 (0%)		1/26 (3.8%)		1/26 (3.8%)
Musculoskeletal Stiffness	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Myalgia	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		3/63 (4.8%)		1/62 (1.6%)		1/26 (3.8%)		1/26 (3.8%)
Osteoarthritis	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		3/62 (4.8%)		1/26 (3.8%)		1/26 (3.8%)
Pain in Extremity	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Periarthritis	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		3/62 (4.8%)		1/26 (3.8%)		1/26 (3.8%)
Plantar Fasciitis	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Psoriatic Arthropathy	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		2/62 (3.2%)		1/26 (3.8%)		0/26 (0%)
Spinal Osteoarthritis	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		1/26 (3.8%)		0/26 (0%)
Synovial Cyst	1/64 (1.6%)		1/65 (1.5%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Tendonitis	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		0/26 (0%)		1/26 (3.8%)
Trigger Finger	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		2/26 (7.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blepharal Papilloma	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Seborrhoeic Keratosis	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Skin Papilloma	0/64 (0%)		0/65 (0%)		0/63 (0%)		3/63 (4.8%)		3/62 (4.8%)		2/26 (7.7%)		1/26 (3.8%)
Nervous system disorders
Dizziness	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Dysgeusia	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Headache	1/64 (1.6%)		0/65 (0%)		1/63 (1.6%)		6/63 (9.5%)		2/62 (3.2%)		1/26 (3.8%)		3/26 (11.5%)
Hypoaesthesia	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		2/62 (3.2%)		1/26 (3.8%)		0/26 (0%)
Post Herpetic Neuralgia	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Radial Nerve Palsy	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Sciatica	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		1/62 (1.6%)		0/26 (0%)		1/26 (3.8%)
Speech Disorder	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Psychiatric disorders
Depression	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Insomnia	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Renal and urinary disorders
Diabetic Nephropathy	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Ureterolithiasis	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		0/63 (0%)		2/62 (3.2%)		0/26 (0%)		0/26 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		2/63 (3.2%)		1/62 (1.6%)		0/26 (0%)		1/26 (3.8%)
Cough	0/64 (0%)		0/65 (0%)		0/63 (0%)		5/63 (7.9%)		2/62 (3.2%)		3/26 (11.5%)		5/26 (19.2%)
Epistaxis	0/64 (0%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Nasal Mucosal Erosion	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Oropharyngeal Pain	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		1/63 (1.6%)		2/62 (3.2%)		0/26 (0%)		0/26 (0%)
Pharyngeal Paraesthesia	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Rhinitis Allergic	0/64 (0%)		1/65 (1.5%)		1/63 (1.6%)		5/63 (7.9%)		1/62 (1.6%)		0/26 (0%)		1/26 (3.8%)
Upper Respiratory Tract Inflammation	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		1/63 (1.6%)		2/62 (3.2%)		2/26 (7.7%)		1/26 (3.8%)
Skin and subcutaneous tissue disorders
Acne	1/64 (1.6%)		0/65 (0%)		1/63 (1.6%)		1/63 (1.6%)		1/62 (1.6%)		2/26 (7.7%)		0/26 (0%)
Alopecia	0/64 (0%)		2/65 (3.1%)		0/63 (0%)		1/63 (1.6%)		0/62 (0%)		0/26 (0%)		0/26 (0%)
Dermatitis	2/64 (3.1%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Dermatitis Contact	0/64 (0%)		0/65 (0%)		0/63 (0%)		5/63 (7.9%)		4/62 (6.5%)		1/26 (3.8%)		0/26 (0%)
Dry Skin	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Dyshidrotic Eczema	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		0/63 (0%)		1/62 (1.6%)		1/26 (3.8%)		1/26 (3.8%)
Eczema	1/64 (1.6%)		0/65 (0%)		0/63 (0%)		3/63 (4.8%)		7/62 (11.3%)		3/26 (11.5%)		5/26 (19.2%)
Eczema Asteatotic	0/64 (0%)		0/65 (0%)		1/63 (1.6%)		2/63 (3.2%)		0/62 (0%)		2/26 (7.7%)		0/26 (0%)
Hand Dermatitis	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Hyperkeratosis	0/64 (0%)		0/65 (0%)		0/63 (0%)		3/63 (4.8%)		1/62 (1.6%)		0/26 (0%)		2/26 (7.7%)
Miliaria	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		2/62 (3.2%)		0/26 (0%)		2/26 (7.7%)
Palmoplantar Pustulosis	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Pruritus	1/64 (1.6%)		0/65 (0%)		1/63 (1.6%)		2/63 (3.2%)		3/62 (4.8%)		1/26 (3.8%)		0/26 (0%)
Psoriasis	11/64 (17.2%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		2/62 (3.2%)		0/26 (0%)		1/26 (3.8%)
Rash	0/64 (0%)		0/65 (0%)		0/63 (0%)		2/63 (3.2%)		0/62 (0%)		0/26 (0%)		1/26 (3.8%)
Urticaria	0/64 (0%)		1/65 (1.5%)		0/63 (0%)		4/63 (6.3%)		4/62 (6.5%)		1/26 (3.8%)		3/26 (11.5%)
Xeroderma	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Vascular disorders
Arteriosclerosis	0/64 (0%)		0/65 (0%)		0/63 (0%)		0/63 (0%)		0/62 (0%)		1/26 (3.8%)		0/26 (0%)
Hypertension	2/64 (3.1%)		2/65 (3.1%)		0/63 (0%)		7/63 (11.1%)		6/62 (9.7%)		5/26 (19.2%)		5/26 (19.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.