A Study in Participants With Moderate to Severe Psoriasis

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01107457
• Collaborator: (none)
• Enrollment: 142
• Locations: 34
• Arms: 7
• Duration (Months): 75
• Patients Per Site: 4.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary purpose for this study is to help answer the following research questions

• The safety of ixekizumab (LY2439821) and any side effects that might be associated with it.

• Whether ixekizumab can help participants with Psoriasis.

• How much ixekizumab should be given to participants.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Biological: Ixekizumab; Drug: Placebo	Phase 2

Detailed Description

The study is a Phase 2 study with 3 parts. Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging design, Part B is an optional, open label extension design and Part C is an additional optional extension period with an open-label design(up to approximately 104 weeks). Approximately 125 participants will be randomized to 1 of 4 ixekizumab groups or to placebo (approximately 25 participants per group) in Part A. Participants will be evaluated for treatment efficacy and the primary endpoint will be evaluated at week 12. Between week 20 and week 32, participants with a less than 75% improvement in their Psoriasis Area and Severity Index (PASI) score compared to baseline will be eligible to begin Part B. Participants in Part B will receive subcutaneous (SC) injections of ixekizumab 120 milligrams (mg) every 4 weeks through week 236. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236. Participants in Part C may receive SC injections of ixekizumab 80 mg every 4 weeks for up to an additional 104 weeks through approximately week 340. Participants who complete Part A, Part B, and Part C will have a total study participation of approximately 344 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 10 mg Ixekizumab Part A: 10 milligrams (mg) ixekizumab given subcutaneous (SC) on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344.	Biological: Ixekizumab; Administered subcutaneously; Other Names: LY2439821
Experimental: 25 mg Ixekizumab Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC (Q4W). Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344.	Biological: Ixekizumab; Administered subcutaneously; Other Names: LY2439821
Experimental: 75 mg Ixekizumab Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344.	Biological: Ixekizumab; Administered subcutaneously; Other Names: LY2439821
Experimental: 150 mg Ixekizumab Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344.	Biological: Ixekizumab; Administered subcutaneously; Other Names: LY2439821
Placebo Comparator: Placebo Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344.	Biological: Ixekizumab; Administered subcutaneously; Other Names: LY2439821 ; Drug: Placebo; Administered subcutaneously
Experimental: 120 mg Ixekizumab Part B: (optional) 120 mg ixekizumab given SC every 4 weeks. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236. Part C: (optional) 80 mg ixekizumab given SC every 4 weeks through approximately week 344.	Biological: Ixekizumab; Administered subcutaneously; Other Names: LY2439821
Experimental: 80 mg Ixekizumab Part B: (optional) Subsequent to an amendment on May 2012, administration changed to 80 mg ixekizumab Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC every 4 weeks through approximately week 344.	Biological: Ixekizumab; Administered subcutaneously; Other Names: LY2439821

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement [Week 12]

   PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.

2. Percentage of PASI Improvement From Baseline to 12 Week Endpoint [Baseline to Week 12]

   The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Least squares (LS) mean values were calculated using mixed model repeated measures (MMRM) and controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.

Secondary Outcome Measures

1. Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement" at Week 12 [Week 12]

   The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6 point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.

2. Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks [Baseline Up to 20 Weeks]

   Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.

3. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16 [Baseline, Week 16]

   The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal. LS mean was calculated using the analysis of covariance (ANCOVA) model including treatment as fixed effect and baseline as covariate.

4. Change From Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16 [Baseline, Week 16]

   The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.

5. Change From Baseline in Patient Global Assessment (PatGA) at Week 12 [Baseline, 12 Weeks]

   The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.

6. Change From Baseline in Pain Visual Analog Scale (VAS) at Week 12 [Baseline, Week 12]

   The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used. Least Squares (LS) Mean values were calculated using MMRM and were controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.

7. Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-S) at Week 16 [Baseline, Week 16]

   MOS-S provides a concise assessment of important dimensions of sleep, including initiation, maintenance, respiratory problems, quantity, perceived adequacy, and somnolence during the past 4 weeks. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100,with higher scores for more impairment); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = higher scores indicate greater problems with the attribute.The LS Mean (no multiplicity adjustments) was calculated using an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.

8. Number of Participants Who Received Medical Care Measured by Medical Care Resource Utilization (PMRU)) [Week 16]

   The PMRU is a 3-item participant-reported questionnaire on health care resource utilization due to psoriasis for physician/clinic visits, emergency room visits, and inpatient hospital admissions since the last study visit.

9. Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI Q) at Week 16 [Baseline, Week 16]

   The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, Absenteeism (work time missed) = (Q2/(Q2+Q4))*100, Presenteeism(impairment at work/reduced on-the-job effectiveness) = (Q5/10) *100, Work productivity loss(overall work impairment /absenteeism plus presenteeism) = (Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]) * 100 and Activity Impairment = (Q6/10) * 100. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity ( worse outcomes). The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.

10. Change From Baseline in Medical Outcomes Study Short-Form 36 (SF-36) - Physical Component Score (PCS) and Mental Component Score (MCS) at Week 16 [Baseline, Week 16]

    The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. The recall period was the past 4 weeks. The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.

11. Change From Baseline in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis at Week 12 [Baseline, Week 12]

    The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If <50% of the toes or finger assessments were missing, the imputation was performed. If >50% of the assessments were missing, then the sum of the scores was left as missing. LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects.

12. Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis at Week 12 [Baseline, Week 12]

    The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.

13. Change From Baseline in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis at Week 12 [Baseline, Week 12]

    The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.

14. Ixekizumab Systemic Clearance (CL) (Serum Concentrations of Ixekizumab From Baseline Through 32 Weeks) [Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32]

    The population pharmacokinetic (PK) modeling value for systemic clearance was based on data from week 1 to week 32 for all participants in all ixekizumab treatment arms.

15. Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Total Score at Week 16 [Baseline, Week 16]

    The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant. The LS Mean(no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.

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

    PASI combines the extent of body surface involvement in 4 anatomical regions(head,trunk,arms,and legs).For each region the percent area of skin involved was estimated from 0(0%) to 6(90%-100%) and severity was estimated by clinical signs of erythema,induration and scaling with a scores range from 0(none) to 4(very severe).Each area is scored by itself and the scores were then combined for the final PASI.Final PASI calculated as:sum of severity parameters for each region*area score*weighing factor (head[0.1],upper limbs[0.2],trunk[0.3],lower limbs [0.4]).Overall scores range from 0(no psoriasis) to 72(most severe disease).The LS mean are presented for each treatment versus placebo comparison at each visit and use ANCOVA model including baseline PASI covariate and treatment as fixed effect in the model.Results at Week 12 are summarized as Improvement in PASI which is defined as a reduction in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.

17. Percentage of Participants Who Achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75) [Week 32]

    PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.

18. Percentage of PASI Improvement From Baseline Through 32 Weeks [Baseline Through 32 Weeks]

    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Improvement in PASI is defined as improvement in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.

19. Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement [Week 32]

    The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.

20. Percentage of Participants With Anti-Ixekizumab Antibodies [Baseline through Week 20]

    Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.

21. Percentage of Participants With Static Physician's Global Assessment (sPGA) of (0,1) [Baseline Up to 240 Weeks]

    The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.

22. Number of Treatment Emergent Adverse Events up to 344 Weeks [Baseline Up to 344 Weeks]

    Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.

23. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) [Baseline Up to 240 Weeks]

    The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal.

24. Number of Participants With Patient's Global Assessment of Disease Activity (PatGA) [Week 240]

    The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been).

25. Change From Baseline in Pain Visual Analog Scale (VAS) [Baseline Up to 240 Weeks]

    The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used.

26. Change From Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis [Baseline Up to 240 Weeks]

    The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If <50% of the toes or finger assessments were missing, the imputation was performed. If >50% of the assessments were missing, then the sum of the scores was left as missing. Baseline is defined as the last available value prior to the first dose in Part A of the study.

27. Change From Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis [Baseline Up to 240 Weeks]

    The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis. Baseline is defined as the last available value prior to the first dose in Part A of the study.

28. Change From Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis [Baseline Up to 240 Weeks]

    The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.

29. Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement [Week 240]

    PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.

30. Change From Baseline in Dermatology Life Quality Index (DLQI) [Baseline Up to 240 Weeks]

    The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant. Baseline is defined as the last available value prior to the first dose in Part A of the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria Common to Both Part A:

• Participant must have active plaque psoriasis covering at least 10% body surface area and a PASI score of at least 12 at screening and at randomization.

• Participant is a candidate for systemic therapy

• Participant has a Static Physician's Global Assessment (sPGA) score of at least 3 at screening and at randomization

Inclusion Criterion Specific to Part B

• Participant has completed the treatment period for part A (at least through week 20)

Inclusion Criterion Specific to Part C

• Participant has completed the treatment period for part B

Exclusion Criteria Common to Part A, B and C:

• Participant has pustular, erythrodermic and/or guttate forms of psoriasis

• Participant has had a clinically significant flare of psoriasis during the 12 weeks prior to study entry

• Participant has recently used any biologic agent/monoclonal antibody within the following washout periods: etanercept >28 days, infliximab or adalimumab >56 days, alefacept >60 days, ustekinumab >8 months, or any other biologic agent/monoclonal antibody >5 half-lives prior to baseline

• Participant has received systemic psoriasis therapy (such as psoralen and ultraviolet A [PUVA] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization (exception: class 6 [mild, such as desonide] or 7 [least potent, such as hydrocortisone] topical steroids will be permitted for use limited to the face, axilla, and/or genitalia)

• Participant has donated more than 500 mL of blood within the last month

• Participant has another serious disorder or illness

• Participant has suffered a serious bacterial infection (for example, pneumonia, and cellulitis) within the last 3 months

• Participant has a history of uncontrolled high blood pressure

• Participant has clinical laboratory test results at entry that are outside the normal reference range

• Participant is currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug

• Participant is a woman who is lactating or breast feeding

• If a participant is a woman and could become pregnant during this study, she must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study

• If a participant is post menopausal woman, she must be at least 45 years of age and have not menstruated for the last 12 months

• If a participant is a woman between 40-45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, she must have an additional blood test to see if you can participate

• If the participant is male, he must agree to reduce the risk of female partner becoming pregnant during the study

Exclusion Criteria Specific to B:

• If a participant experienced a serious adverse event during Part A considered possibly related to ixekizumab

• If a participant experienced an adverse event during Part A that the study doctor believes continued ixekizumab treatment could cause harm to the participant.

Exclusion Criteria Specific to C:

• If a participant experienced a Serious Adverse Event during Part B considered possibly related to ixekizumab

• If a participant experienced an adverse event during Part B that the study doctor believes continued ixekizumab treatment could cause harm to the participant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bakersfield	California	United States	93309
2	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	New Haven	Connecticut	United States	06511
3	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Washington	District of Columbia	United States	20037
4	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Miami	Florida	United States	33175
5	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Miramar	Florida	United States	33027
6	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Newnan	Georgia	United States	30263
7	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Arlington Heights	Illinois	United States	60005
8	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Skokie	Illinois	United States
9	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	West Dundee	Illinois	United States	60118
10	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	South Bend	Indiana	United States	46617
11	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Boston	Massachusetts	United States	02114
12	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ann Arbor	Michigan	United States	48109
13	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Saint Louis	Missouri	United States	63117
14	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Omaha	Nebraska	United States	68144
15	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Reno	Nevada	United States	89511
16	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Jamaica	New York	United States	11418
17	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	New York	New York	United States	10029
18	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Rochester	New York	United States	14623
19	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Stony Brook	New York	United States	11790
20	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Winston-Salem	North Carolina	United States	27103
21	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Cleveland	Ohio	United States	44106
22	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lake Oswego	Oregon	United States	97035
23	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Portland	Oregon	United States	97223
24	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Philadelphia	Pennsylvania	United States	19103
25	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Knoxville	Tennessee	United States	37922
26	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nashville	Tennessee	United States	37215
27	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	College Station	Texas	United States	77845
28	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Dallas	Texas	United States	75246
29	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	San Antonio	Texas	United States	78229
30	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Norfolk	Virginia	United States	23507
31	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Richmond	Virginia	United States	23294
32	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Aarhus		Denmark	8000
33	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hellerup		Denmark	2900
34	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kobenhavn		Denmark	2400

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01107457
• Other Study ID Numbers: 12060; I1F-MC-RHAJ
• First Posted: Apr 21, 2010
• Last Update Posted: Sep 24, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Eli Lilly and Company: Moderate; Severe; Plaque; Chronic
• Additional relevant MeSH terms: Psoriasis; Ixekizumab

Study Results

Participant Flow

Recruitment Details	This study has 3 parts:Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose ranging design (approximately 20-40 weeks [wks]).Treatment durability (sustained efficacy off treatment) from Week 20 up to Week 32 was evaluated during Part A.
Pre-assignment Detail	Part B is an optional extension period with an open-label design (approximately 240 weeks). Part C is an additional optional extension period with an open-label design(up to approximately 104 weeks).

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab	120 mg/80 mg Total Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 milligrams (mg) ixekizumab given subcutaneous (SC) every 4 weeks (Q4W). Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through week 344.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through week 344.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through week 344.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through week 344.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) Administered 80 mg ixekizumab SC Q4W through week 344.	Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through week 344.
Period Title: Part A
STARTED	27	28	30	29	28	0
Received at Least 1 Dose of Study Drug	27	28	30	29	28	0
COMPLETED	22	21	29	26	27	0
NOT COMPLETED	5	7	1	3	1	0
Period Title: Part A
STARTED	0	0	0	0	0	120
Completed Part B (Week 240)	0	0	0	0	0	74
Completed Part C	0	0	0	0	0	0
Post Treatment Safety Visits	0	0	0	0	0	6
COMPLETED	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	120

Baseline Characteristics

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab	Total
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through week 344.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through week 344.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through week 344.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through week 344.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) Administered 80 mg ixekizumab SC Q4W through week 344.	Total of all reporting groups
Overall Participants	27	28	30	29	28	142
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45 (12.76)	47.65 (11.20)	45.93 (14.53)	46.37 (12.50)	45.97 (13.00)	46.19 (12.71)
Sex: Female, Male (Count of Participants)
Female	13 48.1%	12 42.9%	12 40%	10 34.5%	14 50%	61 43%
Male	14 51.9%	16 57.1%	18 60%	19 65.5%	14 50%	81 57%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 18.5%	5 17.9%	7 23.3%	4 13.8%	4 14.3%	25 17.6%
Not Hispanic or Latino	22 81.5%	23 82.1%	23 76.7%	25 86.2%	24 85.7%	117 82.4%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	1 3.3%	1 3.4%	0 0%	2 1.4%
Asian	0 0%	1 3.6%	0 0%	2 6.9%	1 3.6%	4 2.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	2 7.4%	0 0%	1 3.3%	2 6.9%	2 7.1%	7 4.9%
White	25 92.6%	27 96.4%	28 93.3%	24 82.8%	25 89.3%	129 90.8%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	27 100%	27 96.4%	29 96.7%	28 96.6%	28 100%	139 97.9%
Denmark	0 0%	1 3.6%	1 3.3%	1 3.4%	0 0%	3 2.1%
Baseline in Psoriasis Area and Severity Index (PASI) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	16.45 (5.26)	19.18 (7.96)	18.55 (4.94)	17.20 (4.26)	17.70 (6.21)	17.83 (5.85)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
Description	PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	26	28	30	29	28
Number [percentage of participants]	7.7 28.5%	28.6 102.1%	76.7 255.7%	82.8 285.5%	82.1 293.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg Ixekizumab
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.079
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 25 mg Ixekizumab
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg Ixekizumab
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, 150 mg Ixekizumab
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

2. Primary Outcome

Title	Percentage of PASI Improvement From Baseline to 12 Week Endpoint
Description	The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Least squares (LS) mean values were calculated using mixed model repeated measures (MMRM) and controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline PASI assessment.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	23	27	29	29	26
Least Squares Mean (95% Confidence Interval) [Percentage of improvement in PASI score]	16.22	49.33	78.48	85.69	87.12

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg Ixekizumab
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 25 mg Ixekizumab
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg Ixekizumab
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, 150 mg Ixekizumab
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement" at Week 12
Description	The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6 point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	26	28	30	29	28
Number [percentage of participants]	7.7 28.5%	25.0 89.3%	70.0 233.3%	72.4 249.7%	71.4 255%

4. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks
Description	Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Time Frame	Baseline Up to 20 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	27	28	30	29	28
Number [Participants]	17 63%	21 75%	21 70%	17 58.6%	13 46.4%

5. Secondary Outcome

Title	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16
Description	The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal. LS mean was calculated using the analysis of covariance (ANCOVA) model including treatment as fixed effect and baseline as covariate.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	25	28	29	29	28
Anxiety	-0.86 (0.58)	-1.97 (0.55)	-2.10 (0.54)	-2.17 (0.54)	-2.81 (0.55)
Depression	0.17 (0.54)	-1.86 (0.51)	-1.75 (0.51)	-2.52 (0.51)	-2.01 (0.51)

6. Secondary Outcome

Title	Change From Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16
Description	The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	24	27	26	27	25
Least Squares Mean (Standard Error) [units on a scale]	-0.49 (0.56)	-1.56 (0.52)	-1.48 (0.53)	-2.13 (0.52)	-2.21 (0.54)

7. Secondary Outcome

Title	Change From Baseline in Patient Global Assessment (PatGA) at Week 12
Description	The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.
Time Frame	Baseline, 12 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	26	28	30	29	28
Least Squares Mean (Standard Error) [units on a scale]	-0.6 (0.3)	-1.1 (0.3)	-2.3 (0.2)	-2.9 (0.3)	-2.5 (0.3)

8. Secondary Outcome

Title	Change From Baseline in Pain Visual Analog Scale (VAS) at Week 12
Description	The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used. Least Squares (LS) Mean values were calculated using MMRM and were controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with self-reported psoriatic arthritis at baseline were included in the analysis. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	4	7	11	8	8
Least Squares Mean (95% Confidence Interval) [millimeter (mm)]	3.87	-4.32	-19.36	-21.24	-34.24

9. Secondary Outcome

Title	Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-S) at Week 16
Description	MOS-S provides a concise assessment of important dimensions of sleep, including initiation, maintenance, respiratory problems, quantity, perceived adequacy, and somnolence during the past 4 weeks. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100,with higher scores for more impairment); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = higher scores indicate greater problems with the attribute.The LS Mean (no multiplicity adjustments) was calculated using an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	25	28	29	29	28
Sleep Problems Index I	-0.05 (2.61)	-5.35 (2.46)	-8.78 (2.42)	-7.97 (2.42)	-2.38 (2.47)
Sleep Problems Index II	0.21 (2.37)	-6.42 (2.24)	-9.23 (2.20)	-8.43 (2.20)	-2.48 (2.24)
Sleep Adequacy	-2.83 (4.73)	5.63 (4.47)	11.35 (4.39)	8.81 (4.39)	-0.41 (4.48)
Sleep Disturbance	-1.47 (3.27)	-8.56 (3.10)	-10.02 (3.03)	-11.50 (3.04)	-4.67 (3.09)
Sleep Somnolence	1.12 (2.73)	-2.32 (2.58)	-7.14 (2.53)	-5.80 (2.53)	-0.76 (2.58)
Snoring	-2.85 (4.22)	-0.47 (3.94)	2.94 (3.88)	-3.24 (3.87)	-3.81 (3.94)
Sleep Short of Breath/headache	4.34 (3.10)	-5.45 (2.92)	-2.84 (2.87)	-2.65 (2.87)	-3.46 (2.91)

10. Secondary Outcome

Title	Number of Participants Who Received Medical Care Measured by Medical Care Resource Utilization (PMRU))
Description	The PMRU is a 3-item participant-reported questionnaire on health care resource utilization due to psoriasis for physician/clinic visits, emergency room visits, and inpatient hospital admissions since the last study visit.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	26	28	30	29	28
Week 16 - Office or Clinic(n=23,24,29,28,27)	1 3.7%	0 0%	0 0%	1 3.4%	3 10.7%
Week 16 - Emergency Room(ER)(n=23, 24, 29, 28, 27)	0 0%	0 0%	0 0%	0 0%	1 3.6%
Week 16 - Admitted thru ER (n=26,28,30,29,28)	0 0%	0 0%	0 0%	0 0%	0 0%
Week 16 - Hospital Stay (n=26,28,30,29,28)	0 0%	0 0%	0 0%	0 0%	0 0%

11. Secondary Outcome

Title	Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI Q) at Week 16
Description	The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, Absenteeism (work time missed) = (Q2/(Q2+Q4))*100, Presenteeism(impairment at work/reduced on-the-job effectiveness) = (Q5/10) *100, Work productivity loss(overall work impairment /absenteeism plus presenteeism) = (Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]) * 100 and Activity Impairment = (Q6/10) * 100. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity ( worse outcomes). The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	26	28	30	29	28
Absenteeism (n=15,19,14,19,16)	-1.91 (1.88)	0.71 (1.68)	-0.83 (1.94)	-2.64 (1.67)	-1.96 (1.82)
Presenteeism (n=15,20,16,19,16)	-3.38 (3.99)	-0.99 (3.47)	-4.59 (3.87)	-14.48 (3.55)	-10.69 (3.90)
Work productivity loss (n=15,19,14,19,16)	-3.65 (4.30)	1.74 (3.82)	-4.65 (4.45)	-14.76 (3.82)	-11.12 (4.17)
Activity Impairment (n=25,28,28,29,27)	-0.68 (4.19)	-9.76 (3.96)	-14.96 (3.95)	-12.81 (3.90)	-14.79 (4.03)

12. Secondary Outcome

Title	Change From Baseline in Medical Outcomes Study Short-Form 36 (SF-36) - Physical Component Score (PCS) and Mental Component Score (MCS) at Week 16
Description	The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. The recall period was the past 4 weeks. The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	25	28	28	29	28
PCS	-1.22 (2.15)	2.41 (2.03)	1.95 (2.03)	3.94 (2.00)	5.72 (2.03)
MCS	-0.56 (2.29)	7.27 (2.19)	5.16 (2.18)	4.13 (2.13)	4.15 (2.16)

13. Secondary Outcome

Title	Change From Baseline in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis at Week 12
Description	The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If <50% of the toes or finger assessments were missing, the imputation was performed. If >50% of the assessments were missing, then the sum of the scores was left as missing. LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with baseline nail involvement were included in the analysis.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	14	13	10	10	10
Least Squares Mean (95% Confidence Interval) [units on a scale]	2.21	-4.85	-3.65	-15.89	-19.91

14. Secondary Outcome

Title	Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis at Week 12
Description	The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with palmoplantar involvement were included in the analysis.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	1	4	4	2	2
Least Squares Mean (95% Confidence Interval) [units on a scale]	-1.0	-6.4	-4.6	-3.4	-12.8

15. Secondary Outcome

Title	Change From Baseline in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis at Week 12
Description	The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with baseline scalp involvement were included in the analysis.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	17	21	24	18	22
Least Squares Mean (95% Confidence Interval) [units on a scale]	-7.3	-10.2	-15.8	-15.0	-17.2

16. Secondary Outcome

Title	Ixekizumab Systemic Clearance (CL) (Serum Concentrations of Ixekizumab From Baseline Through 32 Weeks)
Description	The population pharmacokinetic (PK) modeling value for systemic clearance was based on data from week 1 to week 32 for all participants in all ixekizumab treatment arms.
Time Frame	Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had evaluable PK data.

Arm/Group Title	All Participants (10mg, 25mg,75mg & 150 mg Ixekizumab)
Arm/Group Description	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	115
Mean (95% Confidence Interval) [liters per hour (L/hr)]	0.0177

17. Secondary Outcome

Title	Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Total Score at Week 16
Description	The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant. The LS Mean(no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	25	28	29	29	28
Least Squares Mean (Standard Error) [units on a scale]	-1.24 (0.97)	-6.35 (0.92)	-6.59 (0.90)	-8.39 (0.90)	-8.17 (0.92)

18. Secondary Outcome

Title	Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
Description	PASI combines the extent of body surface involvement in 4 anatomical regions(head,trunk,arms,and legs).For each region the percent area of skin involved was estimated from 0(0%) to 6(90%-100%) and severity was estimated by clinical signs of erythema,induration and scaling with a scores range from 0(none) to 4(very severe).Each area is scored by itself and the scores were then combined for the final PASI.Final PASI calculated as:sum of severity parameters for each region*area score*weighing factor (head[0.1],upper limbs[0.2],trunk[0.3],lower limbs [0.4]).Overall scores range from 0(no psoriasis) to 72(most severe disease).The LS mean are presented for each treatment versus placebo comparison at each visit and use ANCOVA model including baseline PASI covariate and treatment as fixed effect in the model.Results at Week 12 are summarized as Improvement in PASI which is defined as a reduction in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	26	28	30	29	28
Least Squares Mean (Standard Error) [units on a scale]	3.50 (1.21)	8.20 (1.17)	13.56 (1.12)	14.99 (1.14)	15.38 (1.16)

19. Secondary Outcome

Title	Percentage of Participants Who Achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75)
Description	PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	6	22	23	23	23
Number [percentage of participants]	0 0%	50.0 178.6%	59.1 197%	56.5 194.8%	82.6 295%

20. Secondary Outcome

Title	Percentage of PASI Improvement From Baseline Through 32 Weeks
Description	The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Improvement in PASI is defined as improvement in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.
Time Frame	Baseline Through 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Zero participants in the placebo arm had data.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	0	4	16	18	21
Mean (Standard Deviation) [Percentage PASI improvement]	80.55 (17.69)	85.60 (12.74)	85.16 (15.30)	88.11 (11.35)

21. Secondary Outcome

Title	Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement
Description	The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values. Zero participants in the placebo arm had data.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	0	6	22	23	23
Number [percentage of participants]	33.3 123.3%	45.5 162.5%	47.8 159.3%	65.2 224.8%

22. Secondary Outcome

Title	Percentage of Participants With Anti-Ixekizumab Antibodies
Description	Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.
Time Frame	Baseline through Week 20

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had a baseline and at least one post-baseline antibody assessment.

Arm/Group Title	Placebo	10 mg Ixekizumab	25 mg Ixekizumab	75 mg Ixekizumab	150 mg Ixekizumab
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.	Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Measure Participants	25	24	30	29	27
Number [percentage of participants]	4.0 14.8%	54.2 193.6%	40.0 133.3%	17.2 59.3%	22.2 79.3%

23. Secondary Outcome

Title	Percentage of Participants With Static Physician's Global Assessment (sPGA) of (0,1)
Description	The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.
Time Frame	Baseline Up to 240 Weeks

Outcome Measure Data

Analysis Population Description

All enrolled participants who had PASI 75 response at Week 20.

Arm/Group Title	Total Ixekizumab (80 mg and 120 mg)
Arm/Group Description	Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC.
Measure Participants	74
Number [percentage of participants]	78.4 290.4%

24. Secondary Outcome

Title	Number of Treatment Emergent Adverse Events up to 344 Weeks
Description	Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Time Frame	Baseline Up to 344 Weeks

Outcome Measure Data

Analysis Population Description

All enrolled participants.

Arm/Group Title	Total Ixekizumab (80 mg and 120 mg)
Arm/Group Description	Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC
Measure Participants	120
Count of Participants [Participants]	105 388.9%

25. Secondary Outcome

Title	Change From Baseline in Hospital Anxiety and Depression Scale (HADS)
Description	The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal.
Time Frame	Baseline Up to 240 Weeks

Outcome Measure Data

Analysis Population Description

All enrolled participants who had PASI 75 response at Week 20.

Arm/Group Title	Total Ixekizumab (80 mg and 120 mg)
Arm/Group Description	Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC
Measure Participants	74
Anxiety	-3.0 (3.4)
Depression	-2.8 (3.0)

26. Secondary Outcome

Title	Number of Participants With Patient's Global Assessment of Disease Activity (PatGA)
Description	The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been).
Time Frame	Week 240

Outcome Measure Data

Analysis Population Description

All enrolled participants who had PASI 75 response at Week 20.

Arm/Group Title	Total Ixekizumab (80 mg and 120 mg)
Arm/Group Description	Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC
Measure Participants	74
0(Clear)	40 148.1%
1	26 96.3%
2	4 14.8%
3	2 7.4%
4	2 7.4%
5(Severe)	0 0%

27. Secondary Outcome

Title	Change From Baseline in Pain Visual Analog Scale (VAS)
Description	The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used.
Time Frame	Baseline Up to 240 Weeks

Outcome Measure Data

Analysis Population Description

All enrolled participants with data available.

Arm/Group Title	Total Ixekizumab (80 mg and 120 mg)
Arm/Group Description	Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC
Measure Participants	24
Mean (Standard Error) [Millimeters (mm)]	-13.25 (32.34)

28. Secondary Outcome

Title	Change From Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis
Description	The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If <50% of the toes or finger assessments were missing, the imputation was performed. If >50% of the assessments were missing, then the sum of the scores was left as missing. Baseline is defined as the last available value prior to the first dose in Part A of the study.
Time Frame	Baseline Up to 240 Weeks

Outcome Measure Data

Analysis Population Description

All enrolled participants with baseline nail psoriasis.

Arm/Group Title	Total Ixekizumab (80 mg and 120 mg)
Arm/Group Description	Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC
Measure Participants	32
Mean (Standard Deviation) [units on a scale]	-33.62 (30.48)

29. Secondary Outcome

Title	Change From Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis
Description	The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis. Baseline is defined as the last available value prior to the first dose in Part A of the study.
Time Frame	Baseline Up to 240 Weeks

Outcome Measure Data

Analysis Population Description

All enrolled participants with baseline scalp psoriasis.

Arm/Group Title	Total Ixekizumab (80 mg and 120 mg)
Arm/Group Description	Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC
Measure Participants	56
Mean (Standard Deviation) [units on a scale]	-19.89 (13.68)

30. Secondary Outcome

Title	Change From Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis
Description	The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.
Time Frame	Baseline Up to 240 Weeks

Outcome Measure Data

Analysis Population Description

All enrolled participants with baseline palmoplantar psoriasis.

Arm/Group Title	Total Ixekizumab (80 mg and 120 mg)
Arm/Group Description	Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC
Measure Participants	4
Mean (Standard Deviation) [units on a scale]	-9.10 (7.59)

31. Secondary Outcome

Title	Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
Description	PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.
Time Frame	Week 240

Outcome Measure Data

Analysis Population Description

All enrolled participants who had PASI 75 response at Week 20.

Arm/Group Title	Total Ixekizumab (80 mg and 120 mg)
Arm/Group Description	Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC
Measure Participants	74
Number [percentage of participants]	97.3 360.4%

32. Secondary Outcome

Title	Change From Baseline in Dermatology Life Quality Index (DLQI)
Description	The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant. Baseline is defined as the last available value prior to the first dose in Part A of the study.
Time Frame	Baseline Up to 240 Weeks

Outcome Measure Data

Analysis Population Description

All enrolled participants who had PASI 75 response at Week 20.

Arm/Group Title	Total Ixekizumab (80 mg and 120 mg)
Arm/Group Description	Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC
Measure Participants	74
Mean (Standard Deviation) [units on a scale]	-9.2 (5.6)

Adverse Events

Adverse Event Reporting Description	Treatment durability refers to participants who had a PASI 75 response at Week 20 and remained in Part A of the study from Week 20-32 (treatment-free period). These participants moved to Part B of the study upon completion of Part A through Week 32 or upon loss of PASI75 response during the Part A treatment-free period.
Arm/Group Title	Placebo		10 mg Ixekizumab		25 mg Ixekizumab		75 mg Ixekizumab		150 mg Ixekizumab		Treatment Durability		120 mg and 80 mg Total Ixekizumab		Post Treatment Safety Visits
Arm/Group Description	Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.		Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.		Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.		Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.		Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.		Part A: Treatment durability/safety follow-up period:12 to 20 weeks.		Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.		Participants who were followed due to neutropenia.
All Cause Mortality
	Placebo		10 mg Ixekizumab		25 mg Ixekizumab		75 mg Ixekizumab		150 mg Ixekizumab		Treatment Durability		120 mg and 80 mg Total Ixekizumab		Post Treatment Safety Visits
	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	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		10 mg Ixekizumab		25 mg Ixekizumab		75 mg Ixekizumab		150 mg Ixekizumab		Treatment Durability		120 mg and 80 mg Total Ixekizumab		Post Treatment Safety Visits
	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	Affected / at Risk (%)	# Events
Total	1/27 (3.7%)		1/28 (3.6%)		1/30 (3.3%)		0/29 (0%)		0/28 (0%)		1/74 (1.4%)		24/120 (20%)		0/6 (0%)
Cardiac disorders
Acute coronary syndrome	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Arteriosclerosis coronary artery	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Atrial fibrillation	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Cardiac failure congestive	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Mitral valve prolapse	0/27 (0%)	0	1/28 (3.6%)	1	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Gastrointestinal disorders
Pancreatitis acute	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Infections and infestations
Abdominal abscess	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	2	0/6 (0%)	0
Cellulitis	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	2	0/6 (0%)	0
Incision site infection	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Influenza	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Pyelonephritis	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Soft tissue infection	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Wound infection	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Injury, poisoning and procedural complications
Fall	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Fibula fracture	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Laceration	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Tibia fracture	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Wrist fracture	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	2	0/6 (0%)	0
Intervertebral disc protrusion	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	2	0/6 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Non-small cell lung cancer metastatic	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Rectal adenocarcinoma	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Rectal adenoma	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Uterine leiomyoma	0/13 (0%)	0	0/12 (0%)	0	0/12 (0%)	0	0/10 (0%)	0	0/14 (0%)	0	0/33 (0%)	0	1/50 (2%)	1	0/4 (0%)	0
Nervous system disorders
Cerebrovascular accident	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Pregnancy, puerperium and perinatal conditions
Abortion missed	0/13 (0%)	0	0/12 (0%)	0	0/12 (0%)	0	0/10 (0%)	0	0/14 (0%)	0	0/33 (0%)	0	1/50 (2%)	1	0/4 (0%)	0
Psychiatric disorders
Depression	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	2	0/6 (0%)	0
Suicide attempt	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Renal and urinary disorders
Nephrolithiasis	0/27 (0%)	0	0/28 (0%)	0	1/30 (3.3%)	1	0/29 (0%)	0	0/28 (0%)	0	1/74 (1.4%)	1	2/120 (1.7%)	3	0/6 (0%)	0
Urinary tract obstruction	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Reproductive system and breast disorders
Breast cyst	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Dysmenorrhoea	1/13 (7.7%)	1	0/12 (0%)	0	0/12 (0%)	0	0/10 (0%)	0	0/14 (0%)	0	0/33 (0%)	0	0/50 (0%)	0	0/4 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Laryngeal oedema	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	1	0/6 (0%)	0
Skin and subcutaneous tissue disorders
Hidradenitis	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	1/120 (0.8%)	2	0/6 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		10 mg Ixekizumab		25 mg Ixekizumab		75 mg Ixekizumab		150 mg Ixekizumab		Treatment Durability		120 mg and 80 mg Total Ixekizumab		Post Treatment Safety Visits
	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	Affected / at Risk (%)	# Events
Total	13/27 (48.1%)		15/28 (53.6%)		12/30 (40%)		10/29 (34.5%)		11/28 (39.3%)		11/74 (14.9%)		82/120 (68.3%)		1/6 (16.7%)
Gastrointestinal disorders
Diarrhoea	0/27 (0%)	0	1/28 (3.6%)	1	0/30 (0%)	0	1/29 (3.4%)	1	1/28 (3.6%)	1	0/74 (0%)	0	9/120 (7.5%)	13	0/6 (0%)	0
Nausea	1/27 (3.7%)	1	1/28 (3.6%)	1	0/30 (0%)	0	2/29 (6.9%)	2	0/28 (0%)	0	0/74 (0%)	0	5/120 (4.2%)	7	0/6 (0%)	0
General disorders
Injection site reaction	0/27 (0%)	0	0/28 (0%)	0	3/30 (10%)	4	1/29 (3.4%)	1	2/28 (7.1%)	3	0/74 (0%)	0	4/120 (3.3%)	17	0/6 (0%)	0
Peripheral swelling	2/27 (7.4%)	3	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	0/120 (0%)	0	0/6 (0%)	0
Immune system disorders
Hypersensitivity	1/27 (3.7%)	1	1/28 (3.6%)	1	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	0/120 (0%)	0	1/6 (16.7%)	2
Infections and infestations
Bronchitis	0/27 (0%)	0	1/28 (3.6%)	1	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	10/120 (8.3%)	16	0/6 (0%)	0
Ear infection	0/27 (0%)	0	2/28 (7.1%)	2	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	6/120 (5%)	6	0/6 (0%)	0
Influenza	0/27 (0%)	0	0/28 (0%)	0	1/30 (3.3%)	1	0/29 (0%)	0	1/28 (3.6%)	1	1/74 (1.4%)	1	9/120 (7.5%)	10	0/6 (0%)	0
Nasopharyngitis	5/27 (18.5%)	5	3/28 (10.7%)	3	3/30 (10%)	3	3/29 (10.3%)	3	4/28 (14.3%)	4	2/74 (2.7%)	2	29/120 (24.2%)	57	0/6 (0%)	0
Sinusitis	1/27 (3.7%)	1	0/28 (0%)	0	0/30 (0%)	0	1/29 (3.4%)	1	0/28 (0%)	0	1/74 (1.4%)	1	17/120 (14.2%)	24	0/6 (0%)	0
Tooth infection	0/27 (0%)	0	1/28 (3.6%)	1	0/30 (0%)	0	1/29 (3.4%)	1	0/28 (0%)	0	0/74 (0%)	0	11/120 (9.2%)	12	0/6 (0%)	0
Upper respiratory tract infection	1/27 (3.7%)	1	1/28 (3.6%)	1	3/30 (10%)	3	1/29 (3.4%)	1	1/28 (3.6%)	1	0/74 (0%)	0	15/120 (12.5%)	21	0/6 (0%)	0
Urinary tract infection	0/27 (0%)	0	1/28 (3.6%)	1	1/30 (3.3%)	1	0/29 (0%)	0	1/28 (3.6%)	1	2/74 (2.7%)	2	13/120 (10.8%)	23	0/6 (0%)	0
Injury, poisoning and procedural complications
Laceration	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	2/29 (6.9%)	2	1/28 (3.6%)	1	1/74 (1.4%)	1	3/120 (2.5%)	3	0/6 (0%)	0
Muscle strain	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	1/29 (3.4%)	1	0/28 (0%)	0	0/74 (0%)	0	8/120 (6.7%)	11	0/6 (0%)	0
Metabolism and nutrition disorders
Hypertriglyceridaemia	2/27 (7.4%)	2	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	3/120 (2.5%)	3	0/6 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	1/27 (3.7%)	1	0/28 (0%)	0	1/30 (3.3%)	1	1/29 (3.4%)	1	0/28 (0%)	0	1/74 (1.4%)	1	7/120 (5.8%)	7	0/6 (0%)	0
Back pain	0/27 (0%)	0	1/28 (3.6%)	1	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	8/120 (6.7%)	8	0/6 (0%)	0
Psoriatic arthropathy	2/27 (7.4%)	2	0/28 (0%)	0	0/30 (0%)	0	0/29 (0%)	0	0/28 (0%)	0	0/74 (0%)	0	6/120 (5%)	6	0/6 (0%)	0
Nervous system disorders
Dizziness	0/27 (0%)	0	2/28 (7.1%)	2	0/30 (0%)	0	2/29 (6.9%)	2	0/28 (0%)	0	0/74 (0%)	0	0/120 (0%)	0	0/6 (0%)	0
Headache	1/27 (3.7%)	1	4/28 (14.3%)	7	4/30 (13.3%)	11	1/29 (3.4%)	1	1/28 (3.6%)	1	3/74 (4.1%)	3	12/120 (10%)	20	0/6 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	0/27 (0%)	0	1/28 (3.6%)	1	0/30 (0%)	0	2/29 (6.9%)	2	0/28 (0%)	0	0/74 (0%)	0	5/120 (4.2%)	5	0/6 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis contact	0/27 (0%)	0	0/28 (0%)	0	1/30 (3.3%)	1	0/29 (0%)	0	2/28 (7.1%)	2	0/74 (0%)	0	8/120 (6.7%)	15	0/6 (0%)	0
Dry skin	0/27 (0%)	0	0/28 (0%)	0	0/30 (0%)	0	1/29 (3.4%)	1	2/28 (7.1%)	2	1/74 (1.4%)	1	0/120 (0%)	0	0/6 (0%)	0
Vascular disorders
Hypertension	1/27 (3.7%)	1	0/28 (0%)	0	1/30 (3.3%)	1	1/29 (3.4%)	1	1/28 (3.6%)	1	0/74 (0%)	0	7/120 (5.8%)	8	0/6 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.