BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02684370
• Collaborator: Boehringer Ingelheim (Industry)
• Enrollment: 560
• Arms: 3
• Actual Duration (Months): 19

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: risankizumab; Drug: placebo for risankizumab; Drug: ustekinumab; Drug: placebo for ustekinumab	Phase 3

Detailed Description

Participants were randomized to receive either placebo, ustekinumab, or risankizumab in Part

1. All participants received 2 sets of injections to maintain the blind: the placebo arm received placebo for risankizumab and placebo for ustekinumab), the risankizumab arm received risankizumab and placebo for ustekinumab, and the ustekinumab arm received ustekinumab and placebo for risankizumab. Participants who received placebo in Part A switched to risankizumab in Part B; participants who received ustekinumab or risankizumab in Part A continued to receive the same treatment (ustekinumab or risankizumab) in Part B.

Study Design

• Study Type: Interventional
• Actual Enrollment: 560 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: BI 655066/ABBV-066 (Risankizumab) Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trIal for Maintenance Use in Moderate to Severe Plaque Type Psoriasis (UltIMMa-1)
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo (Part A) Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Drug: placebo for risankizumab; Placebo for risankizumab administered by subcutaneous (SC) injection; Drug: placebo for ustekinumab; Placebo for ustekinumab administered by subcutaneous (SC) injection
Active Comparator: Ustekinumab (Part A) Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Drug: placebo for risankizumab; Placebo for risankizumab administered by subcutaneous (SC) injection; Drug: ustekinumab; Ustekinumab administered by subcutaneous (SC) injection
Experimental: Risankizumab (Part A) Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Drug: risankizumab; Risankizumab administered by subcutaneous (SC) injection; Other Names: ABBV-066 BI 655066 SKYRIZI ; Drug: placebo for ustekinumab; Placebo for ustekinumab administered by subcutaneous (SC) injection

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) [Week 16]

   PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.

2. Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) [Week 16]

   The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

Secondary Outcome Measures

1. Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) [Week 16]

   The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

2. Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) [Week 16]

   PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

3. Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) [Week 16]

   DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired.). A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.

4. Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) [Week 16]

   The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.

5. Percentage of Participants Achieving PASI90 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) [Week 16]

   PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.

6. Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) [Week 16]

   The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

7. Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) [Week 16]

   PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

8. Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) [Week 16]

   The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

9. Percentage of Participants Achieving PASI90 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B) [Week 52]

   PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.

10. Percentage of Participants Achieving PASI100 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B) [Week 52]

    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.

11. Percentage of Participants Achieving sPGA Score of Clear at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B) [Week 52]

    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

12. Percentage of Participants Achieving PASI75 at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) [Week 12]

    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

13. Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) [Week 12]

    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

14. Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) [Week 16]

    DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired.). A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.

15. PSS Total Score: Change From Baseline to Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) [Baseline, Week 16]

    The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. A negative change from Baseline indicates improvement. Last observation carried forward (LOCF) imputation was used for missing data.

Eligibility Criteria

Criteria

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

Inclusion criteria:

• Male or female patients with age ≥18 years at screening.

• Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.

• Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomisation):

1. Have an involved body surface area (BSA) ≥10% and

2. Have a Psoriasis Area and Severity Index (PASI) score ≥12 and

3. Have a static Physician Global Assessment (sPGA) score of ≥3.

• Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator.

• Must be a candidate for treatment with Stelara® (ustekinumab) according to local label.

Exclusion criteria:

• Patients with:

1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)

2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)

3. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment

• Previous exposure to BI 655066.

• Previous exposure to ustekinumab (Stelara®).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie
• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

• Gordon KB, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, Papp KA, Sofen H, Puig L, Foley P, Ohtsuki M, Flack M, Geng Z, Gu Y, Valdes JM, Thompson EHZ, Bachelez H. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018 Aug 25;392(10148):650-661. doi: 10.1016/S0140-6736(18)31713-6. Epub 2018 Aug 7.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02684370
• Other Study ID Numbers: M16-008; 2014-005117-23; 1311.3
• First Posted: Feb 18, 2016
• Last Update Posted: Jul 30, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by AbbVie: Psoriasis; Skin Diseases; Skin Diseases, Papulosquamous; ustekinumab; Dermatologic Agents; ABBV-066; BI 655066; risankizumab
• Additional relevant MeSH terms: Psoriasis; Ustekinumab; Antibodies, Monoclonal

Study Results

Participant Flow

Pre-assignment Detail	A total of 560 subjects were enrolled; 54 subjects failed screening and are excluded from the analyses.

Arm/Group Title	Placebo (Part A)	Ustekinumab (Part A)	Risankizumab (Part A)	Placebo/Risankizumab (Part B)	Ustekinumab/Ustekinumab (Part B)	Risankizumab/Risankizumab (Part B)
Arm/Group Description	Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).	Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).	Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
Period Title: Part A
STARTED	102	100	304	0	0	0
COMPLETED	98	99	299	0	0	0
NOT COMPLETED	4	1	5	0	0	0
Period Title: Part A
STARTED	0	0	0	97	99	297
COMPLETED	0	0	0	95	94	289
NOT COMPLETED	0	0	0	2	5	8

Baseline Characteristics

Arm/Group Title	Placebo (Part A)	Ustekinumab (Part A)	Risankizumab (Part A)	Total
Arm/Group Description	Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Total of all reporting groups
Overall Participants	102	100	304	506
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.3 (13.63)	46.5 (13.42)	48.3 (13.39)	48.1 (13.45)
Sex: Female, Male (Count of Participants)
Female	23 22.5%	30 30%	92 30.3%	145 28.7%
Male	79 77.5%	70 70%	212 69.7%	361 71.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	12 11.8%	12 12%	23 7.6%	47 9.3%
Not Hispanic or Latino	90 88.2%	88 88%	281 92.4%	459 90.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 2%	2 2%	7 2.3%	11 2.2%
Asian	28 27.5%	22 22%	86 28.3%	136 26.9%
Native Hawaiian or Other Pacific Islander	0 0%	1 1%	1 0.3%	2 0.4%
Black or African American	1 1%	1 1%	10 3.3%	12 2.4%
White	71 69.6%	74 74%	200 65.8%	345 68.2%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
Description	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Placebo (Part A)	Risankizumab (Part A)
Arm/Group Description	Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Measure Participants	102	304
Number [percentage of participants]	4.9 4.8%	75.3 75.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	70.3
	Confidence Interval	(2-Sided) 95%; 64.0 to 76.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

2. Primary Outcome

Title	Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
Description	The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Placebo (Part A)	Risankizumab (Part A)
Arm/Group Description	Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Measure Participants	102	304
Number [percentage of participants]	7.8 7.6%	87.8 87.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	79.9
	Confidence Interval	(2-Sided) 95%; 73.5 to 86.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

3. Secondary Outcome

Title	Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
Description	The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Placebo (Part A)	Risankizumab (Part A)
Arm/Group Description	Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Measure Participants	102	304
Number [percentage of participants]	2.0 2%	36.8 36.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	34.7
	Confidence Interval	(2-Sided) 95%; 28.6 to 40.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

4. Secondary Outcome

Title	Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
Description	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Placebo (Part A)	Risankizumab (Part A)
Arm/Group Description	Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Measure Participants	102	304
Number [percentage of participants]	0 0%	35.9 35.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	35.5
	Confidence Interval	(2-Sided) 95%; 30.0 to 41.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

5. Secondary Outcome

Title	Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
Description	DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired.). A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Placebo (Part A)	Risankizumab (Part A)
Arm/Group Description	Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Measure Participants	102	304
Number [percentage of participants]	7.8 7.6%	65.8 65.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	57.9
	Confidence Interval	(2-Sided) 95%; 50.4 to 65.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

6. Secondary Outcome

Title	Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
Description	The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Placebo (Part A)	Risankizumab (Part A)
Arm/Group Description	Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Measure Participants	102	304
Number [percentage of participants]	2.0 2%	29.3 29.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	27.1
	Confidence Interval	(2-Sided) 95%; 21.2 to 32.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

7. Secondary Outcome

Title	Percentage of Participants Achieving PASI90 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
Description	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Ustekinumab (Part A)	Risankizumab (Part A)
Arm/Group Description	Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) SC at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Measure Participants	100	304
Number [percentage of participants]	42.0 41.2%	75.3 75.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	33.5
	Confidence Interval	(2-Sided) 95%; 22.7 to 44.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

8. Secondary Outcome

Title	Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
Description	The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Ustekinumab (Part A)	Risankizumab (Part A)
Arm/Group Description	Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Measure Participants	100	304
Number [percentage of participants]	63.0 61.8%	87.8 87.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	25.1
	Confidence Interval	(2-Sided) 95%; 15.2 to 35.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

9. Secondary Outcome

Title	Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
Description	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Ustekinumab (Part A)	Risankizumab (Part A)
Arm/Group Description	Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Measure Participants	100	304
Number [percentage of participants]	12.0 11.8%	35.9 35.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	23.8
	Confidence Interval	(2-Sided) 95%; 15.5 to 32.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

10. Secondary Outcome

Title	Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
Description	The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Ustekinumab (Part A)	Risankizumab (Part A)
Arm/Group Description	Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Measure Participants	100	304
Number [percentage of participants]	14.0 13.7%	36.8 36.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	22.9
	Confidence Interval	(2-Sided) 95%; 14.3 to 31.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

11. Secondary Outcome

Title	Percentage of Participants Achieving PASI90 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)
Description	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.

Arm/Group Title	Ustekinumab/Ustekinumab (Part B)	Risankizumab/Risankizumab (Part B)
Arm/Group Description	Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).	Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
Measure Participants	100	304
Number [percentage of participants]	44.0 43.1%	81.9 81.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments	P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	38.3
	Confidence Interval	(2-Sided) 95%; 27.9 to 48.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

12. Secondary Outcome

Title	Percentage of Participants Achieving PASI100 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)
Description	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.

Arm/Group Title	Ustekinumab/Ustekinumab (Part B)	Risankizumab/Risankizumab (Part B)
Arm/Group Description	Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).	Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
Measure Participants	304	100
Number [percentage of participants]	21.0 20.6%	56.3 56.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	35.1
	Confidence Interval	(2-Sided) 95%; 25.7 to 44.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

13. Secondary Outcome

Title	Percentage of Participants Achieving sPGA Score of Clear at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)
Description	The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.

Arm/Group Title	Ustekinumab/Ustekinumab (Part B)	Risankizumab/Risankizumab (Part B)
Arm/Group Description	Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).	Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
Measure Participants	100	304
Number [percentage of participants]	21.0 20.6%	57.6 57.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	36.5
	Confidence Interval	(2-Sided) 95%; 27.0 to 45.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

14. Secondary Outcome

Title	Percentage of Participants Achieving PASI75 at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
Description	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Ustekinumab (Part A)	Risankizumab (Part A)
Arm/Group Description	Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Measure Participants	100	304
Number [percentage of participants]	70.0 68.6%	86.8 86.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	17.0
	Confidence Interval	(2-Sided) 95%; 7.4 to 26.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

15. Secondary Outcome

Title	Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
Description	The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Ustekinumab (Part A)	Risankizumab (Part A)
Arm/Group Description	Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Measure Participants	100	304
Number [percentage of participants]	65.0 63.7%	82.2 82.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	17.3
	Confidence Interval	(2-Sided) 95%; 7.3 to 27.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

16. Secondary Outcome

Title	Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
Description	DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired.). A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Ustekinumab (Part A)	Risankizumab (Part A)
Arm/Group Description	Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Measure Participants	100	304
Number [percentage of participants]	43.0 42.2%	65.8 65.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	adjusted difference in percentage
	Estimated Value	23.0
	Confidence Interval	(2-Sided) 95%; 11.9 to 34.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.

17. Secondary Outcome

Title	PSS Total Score: Change From Baseline to Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
Description	The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. A negative change from Baseline indicates improvement. Last observation carried forward (LOCF) imputation was used for missing data.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

ITT population. Last observation carried forward. Participants randomized to placebo or risankizumab with an observed baseline PSS and at least one post-baseline PSS observation on or prior to Week 16.

Arm/Group Title	Placebo (Part A)	Risankizumab (Part A)
Arm/Group Description	Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).	Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Measure Participants	83	251
Least Squares Mean (Standard Error) [units on a scale]	0.157 (0.3476)	-5.608 (0.2254)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (Part A), Risankizumab (Part A)
	Comments	P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	van Elteren test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.765
	Confidence Interval	(2-Sided) 95%; -6.496 to -5.035
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
Adverse Event Reporting Description	TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
Arm/Group Title	Placebo (Part A)		Ustekinumab (Part A)		Risankizumab (Part A)		Placebo/Risankizumab (Part B)		Ustekinumab/Ustekinumab (Part B)		Risankizumab/Risankizumab (Part B)
Arm/Group Description	Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).		Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).		Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).		Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).		Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).		Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
All Cause Mortality
	Placebo (Part A)		Ustekinumab (Part A)		Risankizumab (Part A)		Placebo/Risankizumab (Part B)		Ustekinumab/Ustekinumab (Part B)		Risankizumab/Risankizumab (Part B)
	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	0/102 (0%)		0/100 (0%)		0/304 (0%)		0/97 (0%)		0/99 (0%)		0/297 (0%)
Serious Adverse Events
	Placebo (Part A)		Ustekinumab (Part A)		Risankizumab (Part A)		Placebo/Risankizumab (Part B)		Ustekinumab/Ustekinumab (Part B)		Risankizumab/Risankizumab (Part B)
	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	3/102 (2.9%)		8/100 (8%)		7/304 (2.3%)		3/97 (3.1%)		4/99 (4%)		16/297 (5.4%)
Cardiac disorders
Angina pectoris	0/102 (0%)	0	1/100 (1%)	1	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	0/297 (0%)	0
Angina unstable	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Coronary artery disease	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Left ventricular failure	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Mitral valve incompetence	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Prinzmetal angina	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Supraventricular tachycardia	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Ear and labyrinth disorders
Hypoacusis	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Gastrointestinal disorders
Enteritis	0/102 (0%)	0	0/100 (0%)	0	1/304 (0.3%)	1	0/97 (0%)	0	0/99 (0%)	0	0/297 (0%)	0
Gastrooesophageal reflux disease	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Pancreatitis acute	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
General disorders
Chest pain	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Hepatobiliary disorders
Bile duct stone	1/102 (1%)	1	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	0/297 (0%)	0
Cholecystitis acute	1/102 (1%)	1	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	0/297 (0%)	0
Cholelithiasis	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	1/97 (1%)	1	1/99 (1%)	1	0/297 (0%)	0
Drug-induced liver injury	0/102 (0%)	0	1/100 (1%)	1	1/304 (0.3%)	1	0/97 (0%)	0	0/99 (0%)	0	0/297 (0%)	0
Liver injury	0/102 (0%)	0	1/100 (1%)	1	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	0/297 (0%)	0
Infections and infestations
Anal abscess	0/102 (0%)	0	1/100 (1%)	1	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	0/297 (0%)	0
Cellulitis	0/102 (0%)	0	0/100 (0%)	0	1/304 (0.3%)	1	1/97 (1%)	1	0/99 (0%)	0	0/297 (0%)	0
Gastroenteritis	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Osteomyelitis	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	1/97 (1%)	1	0/99 (0%)	0	0/297 (0%)	0
Pyelonephritis	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Sepsis	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Sinusitis	0/102 (0%)	0	1/100 (1%)	1	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	0/297 (0%)	0
Tonsillitis	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	1/99 (1%)	1	0/297 (0%)	0
Injury, poisoning and procedural complications
Wound complication	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	1/97 (1%)	1	0/99 (0%)	0	0/297 (0%)	0
Wrist fracture	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	0/102 (0%)	0	0/100 (0%)	0	1/304 (0.3%)	1	0/97 (0%)	0	0/99 (0%)	0	0/297 (0%)	0
Intervertebral disc protrusion	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Lumbar spinal stenosis	0/102 (0%)	0	1/100 (1%)	1	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	0/297 (0%)	0
Psoriatic arthropathy	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	1/97 (1%)	1	0/99 (0%)	0	0/297 (0%)	0
Squamous cell carcinoma of skin	1/102 (1%)	1	0/100 (0%)	0	1/304 (0.3%)	1	1/97 (1%)	2	0/99 (0%)	0	0/297 (0%)	0
Nervous system disorders
Post herpetic neuralgia	0/102 (0%)	0	1/100 (1%)	1	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	0/297 (0%)	0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/102 (0%)	0	0/100 (0%)	0	1/304 (0.3%)	1	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Psychiatric disorders
Acute psychosis	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	1/99 (1%)	1	0/297 (0%)	0
Schizoaffective disorder	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	1/99 (1%)	1	0/297 (0%)	0
Suicidal ideation	0/102 (0%)	0	1/100 (1%)	1	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	0/297 (0%)	0
Reproductive system and breast disorders
Female genital tract fistula	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Ovarian cyst	1/102 (1%)	1	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	0/297 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Sleep apnoea syndrome	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	1/99 (1%)	1	0/297 (0%)	0
Surgical and medical procedures
Abortion induced	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Vascular disorders
Hypertension	0/102 (0%)	0	0/100 (0%)	0	1/304 (0.3%)	1	0/97 (0%)	0	0/99 (0%)	0	0/297 (0%)	0
Thrombophlebitis	0/102 (0%)	0	0/100 (0%)	0	0/304 (0%)	0	0/97 (0%)	0	0/99 (0%)	0	1/297 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Placebo (Part A)		Ustekinumab (Part A)		Risankizumab (Part A)		Placebo/Risankizumab (Part B)		Ustekinumab/Ustekinumab (Part B)		Risankizumab/Risankizumab (Part B)
	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	16/102 (15.7%)		16/100 (16%)		45/304 (14.8%)		25/97 (25.8%)		36/99 (36.4%)		75/297 (25.3%)
Infections and infestations
Upper respiratory tract infection	2/102 (2%)	2	6/100 (6%)	6	17/304 (5.6%)	20	8/97 (8.2%)	10	11/99 (11.1%)	14	30/297 (10.1%)	32
Urinary tract infection	1/102 (1%)	1	2/100 (2%)	2	1/304 (0.3%)	1	0/97 (0%)	0	5/99 (5.1%)	5	3/297 (1%)	4
Viral upper respiratory tract infection	6/102 (5.9%)	7	6/100 (6%)	8	20/304 (6.6%)	24	15/97 (15.5%)	17	18/99 (18.2%)	20	40/297 (13.5%)	45
Nervous system disorders
Headache	2/102 (2%)	2	2/100 (2%)	2	9/304 (3%)	9	3/97 (3.1%)	3	5/99 (5.1%)	5	5/297 (1.7%)	5
Skin and subcutaneous tissue disorders
Psoriasis	6/102 (5.9%)	6	1/100 (1%)	1	0/304 (0%)	0	0/97 (0%)	0	1/99 (1%)	1	1/297 (0.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.