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BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT02684357
Collaborator
Boehringer Ingelheim (Industry)
577
Enrollment
3
Arms
18
Actual Duration (Months)

Study Details

Study Description

Brief Summary

This is a randomized double blind, double dummy, placebo and active comparator controlled, parallel design study that is being performed to assess the safety and efficacy of risankizumab (BI 655066) to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

Condition or Disease Intervention/Treatment Phase
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 :
577 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
BI 655066 Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trIal for Maintenance Use in Moderate to Severe Plaque Type Psoriasis-2 (UltIMMa-2)
Actual Study Start Date :
Mar 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 were 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 pre-filled syringe, administered by subcutaneous (SC) injection

Drug: placebo for ustekinumab
Placebo for ustekinumab pre-filled syringe, administered by subcutaneous (SC) injection
Active Comparator: Ustekinumab (Part A)

Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

Drug: ustekinumab
Ustekinumab pre-filled syringe, administered by subcutaneous (SC) injection

Drug: placebo for risankizumab
Placebo for risankizumab pre-filled syringe, 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 pre-filled syringe, administered by subcutaneous (SC) injection
Other Names:
  • BI 655066
  • ABBV-066
  • SKYRIZI

    • Drug: placebo for ustekinumab
    Placebo for ustekinumab pre-filled syringe, 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. Non-responder imputation (NRI) was used for missing data.

    2. Percentage of Participants Achieving a 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 a 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 a Psoriasis Symptom Scale (PSS) 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 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. 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. PASI00 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. 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. PASI00 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.

    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 75% 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 a 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. Change From Baseline to Week 16 in PSS Total Score 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 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 in PSS total score indicates improvement. Last observation carried forward (LOCF) imputation was used for missing data.

    16. Percentage of Participants Achieving PASI75 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. PASI75 is defined as at least a 75% 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.

    17. Percentage of Participants Achieving sPGA Score of Clear or Almost 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.

    18. Percentage of Participants Achieving PASI75 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. PASI75 is defined as at least a 75% 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.

    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. Women of childbearing potential* must be ready and able to use highly effective methods of birth control per International Council on Harmonisation (ICH) M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.

    *Women of childbearing potential are defined as:

    • having experienced menarche and are

    • not postmenopausal (12 months with no menses without an alternative medical cause) and are

    • not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).

    • 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.Duration of diagnosis may be reported by the patient,

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

    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.

    • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practices (GCP) and local legislation

    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,

    • Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study (participation in observational studies is permitted),

    • Previous exposure to ustekinumab (Stelara®),

    • Use of any restricted medication, or any drug considered likely to interfere with the safe conduct of the study,

    • Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g., hip replacement, aneurysm removal, stomach ligation),

    • Known chronic or relevant acute infections including active tuberculosis, HIV or viral hepatitis; QuantiFERON® tuberculosis (TB) test or purified protein derivative (PPD) skin test will be performed according to local labelling for comparator products. If the result is positive, patients may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment should have been initiated and maintained according to local country guidelines,

    • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix,

    • Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram [ECG]), or laboratory value at the screening visit outside the reference range that is in the opinion of the investigator, is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data,

    • History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients,

    • Women who is pregnant, nursing, or who plans to become pregnant while in the trial,

    • Previous enrolment in this trial.

    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:

    Publications

    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02684357
    Other Study ID Numbers:
    • M15-995
    • 2015-003622-13
    • 1311.28
    First Posted:
    Feb 18, 2016
    Last Update Posted:
    Aug 23, 2021
    Last Verified:
    Jul 1, 2021
    Keywords provided by AbbVie
    ABBV-066
    BI 655066
    risankizumab
    Additional relevant MeSH terms:
    Psoriasis
    Ustekinumab
    Antibodies, Monoclonal

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail A total of 577 subjects were enrolled; 86 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 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 98 99 294 0 0 0
    COMPLETED 94 96 292 0 0 0
    NOT COMPLETED 4 3 2 0 0 0
    Period Title: Part A
    STARTED 0 0 0 94 94 291
    COMPLETED 0 0 0 91 90 278
    NOT COMPLETED 0 0 0 3 4 13

    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 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 98 99 294 491
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    46.3
    (13.26)
    48.6
    (14.81)
    46.2
    (13.68)
    46.7
    (13.84)
    Sex: Female, Male (Count of Participants)
    Female
    31
    31.6%
    33
    33.3%
    91
    31%
    155
    31.6%
    Male
    67
    68.4%
    66
    66.7%
    203
    69%
    336
    68.4%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    19
    19.4%
    12
    12.1%
    44
    15%
    75
    15.3%
    Not Hispanic or Latino
    79
    80.6%
    87
    87.9%
    250
    85%
    416
    84.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    1%
    0
    0%
    2
    0.7%
    3
    0.6%
    Asian
    7
    7.1%
    4
    4%
    25
    8.5%
    36
    7.3%
    Native Hawaiian or Other Pacific Islander
    1
    1%
    1
    1%
    0
    0%
    2
    0.4%
    Black or African American
    2
    2%
    2
    2%
    10
    3.4%
    14
    2.9%
    White
    87
    88.8%
    91
    91.9%
    255
    86.7%
    433
    88.2%
    More than one race
    0
    0%
    1
    1%
    2
    0.7%
    3
    0.6%
    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. Non-responder imputation (NRI) was used for missing data.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) population: all randomized participants.
    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 98 294
    Number [percentage of participants]
    2.0
    2%
    74.8
    75.6%
    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 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 percentage difference
    Estimated Value 72.5
    Confidence Interval (2-Sided) 95%
    66.8 to 78.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    2. Primary Outcome
    Title Percentage of Participants Achieving a 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 98 294
    Number [percentage of participants]
    5.1
    5.2%
    83.7
    84.5%
    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 percentage difference
    Estimated Value 78.5
    Confidence Interval (2-Sided) 95%
    72.4 to 84.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated by the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. 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 98 294
    Number [percentage of participants]
    3.1
    3.2%
    51.0
    51.5%
    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 percentage difference
    Estimated Value 47.5
    Confidence Interval (2-Sided) 95%
    40.9 to 54.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. 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 98 294
    Number [percentage of participants]
    2.0
    2%
    50.7
    51.2%
    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 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 percentage difference
    Estimated Value 48.2
    Confidence Interval (2-Sided) 95%
    41.9 to 54.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    5. Secondary Outcome
    Title Percentage of Participants Achieving a 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 98 294
    Number [percentage of participants]
    4.1
    4.2%
    66.7
    67.4%
    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 percentage difference
    Estimated Value 62.2
    Confidence Interval (2-Sided) 95%
    55.5 to 68.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    6. Secondary Outcome
    Title Percentage of Participants Achieving a Psoriasis Symptom Scale (PSS) 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 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 98 294
    Number [percentage of participants]
    0
    0%
    31.3
    31.6%
    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 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 percentage difference
    Estimated Value 31.2
    Confidence Interval (2-Sided) 95%
    25.7 to 36.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. 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. 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 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 99 294
    Number [percentage of participants]
    47.5
    48.5%
    74.8
    75.6%
    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 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 percentage difference
    Estimated Value 27.6
    Confidence Interval (2-Sided) 95%
    16.7 to 38.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. 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 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 99 294
    Number [percentage of participants]
    61.6
    62.9%
    83.7
    84.5%
    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 percentage difference
    Estimated Value 22.3
    Confidence Interval (2-Sided) 95%
    12.0 to 32.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. 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. PASI00 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 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 99 294
    Number [percentage of participants]
    24.2
    24.7%
    50.7
    51.2%
    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 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 percentage difference
    Estimated Value 27.0
    Confidence Interval (2-Sided) 95%
    17.0 to 37.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. 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 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 99 294
    Number [percentage of participants]
    25.3
    25.8%
    51.0
    51.5%
    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 percentage difference
    Estimated Value 26.3
    Confidence Interval (2-Sided) 95%
    16.1 to 36.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. 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. 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 99 294
    Number [percentage of participants]
    50.5
    51.5%
    80.6
    81.4%
    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 percentage difference
    Estimated Value 30.2
    Confidence Interval (2-Sided) 95%
    19.6 to 40.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. 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. PASI00 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 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 99 294
    Number [percentage of participants]
    30.3
    30.9%
    59.5
    60.1%
    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 percentage difference
    Estimated Value 29.5
    Confidence Interval (2-Sided) 95%
    18.9 to 40.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. 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 99 294
    Number [percentage of participants]
    30.3
    30.9%
    59.5
    60.1%
    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 percentage difference
    Estimated Value 29.5
    Confidence Interval (2-Sided) 95%
    18.9 to 40.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. 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 75% 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 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 99 294
    Number [percentage of participants]
    69.7
    71.1%
    88.8
    89.7%
    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 percentage difference
    Estimated Value 19.2
    Confidence Interval (2-Sided) 95%
    9.5 to 28.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. 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 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 99 294
    Number [percentage of participants]
    64.6
    65.9%
    82.3
    83.1%
    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 percentage difference
    Estimated Value 18.0
    Confidence Interval (2-Sided) 95%
    7.8 to 28.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    16. Secondary Outcome
    Title Percentage of Participants Achieving a 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 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 99 294
    Number [percentage of participants]
    46.5
    47.4%
    66.7
    67.4%
    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 percentage difference
    Estimated Value 20.2
    Confidence Interval (2-Sided) 95%
    9.1 to 31.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    17. Secondary Outcome
    Title Change From Baseline to Week 16 in PSS Total Score 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 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 in PSS total score indicates improvement. Last observation carried forward (LOCF) imputation was used for missing data.
    Time Frame 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 85 227
    Least Squares Mean (Standard Error) [units on a scale]
    -0.027
    (0.3316)
    -6.402
    (0.2193)
    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 -6.375
    Confidence Interval (2-Sided) 95%
    -7.102 to -5.648
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    18. Secondary Outcome
    Title Percentage of Participants Achieving PASI75 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. PASI75 is defined as at least a 75% 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 98 294
    Number [percentage of participants]
    6.1
    6.2%
    90.8
    91.7%
    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 percentage difference
    Estimated Value 84.7
    Confidence Interval (2-Sided) 95%
    79.0 to 90.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    19. Secondary Outcome
    Title Percentage of Participants Achieving sPGA Score of Clear or Almost 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 99 294
    Number [percentage of participants]
    54.5
    55.6%
    83.3
    84.1%
    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 percentage difference
    Estimated Value 29.1
    Confidence Interval (2-Sided) 95%
    18.5 to 39.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    20. Secondary Outcome
    Title Percentage of Participants Achieving PASI75 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. PASI75 is defined as at least a 75% 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 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 99 294
    Number [percentage of participants]
    76.8
    78.4%
    91.5
    92.4%
    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 percentage difference
    Estimated Value 14.7
    Confidence Interval (2-Sided) 95%
    5.9 to 23.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.

    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; AEs 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 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 0/98 (0%) 0/99 (0%) 1/294 (0.3%) 0/94 (0%) 0/94 (0%) 1/291 (0.3%)
    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 1/98 (1%) 3/99 (3%) 6/294 (2%) 4/94 (4.3%) 3/94 (3.2%) 13/291 (4.5%)
    Cardiac disorders
    Atrial fibrillation 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 1
    Atrial flutter 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 1/94 (1.1%) 1 0/291 (0%) 0
    Cardiac aneurysm 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 1
    Cardiac failure congestive 0/98 (0%) 0 0/99 (0%) 0 1/294 (0.3%) 1 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 1
    Cardiac ventricular thrombosis 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 1
    Coronary artery disease 0/98 (0%) 0 0/99 (0%) 0 1/294 (0.3%) 1 0/94 (0%) 0 1/94 (1.1%) 1 0/291 (0%) 0
    Eye disorders
    Glaucoma 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 1/94 (1.1%) 1 0/94 (0%) 0 0/291 (0%) 0
    Retinal detachment 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 1
    Gastrointestinal disorders
    Colitis 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 1/94 (1.1%) 1 0/94 (0%) 0 0/291 (0%) 0
    Enterovesical fistula 0/98 (0%) 0 0/99 (0%) 0 1/294 (0.3%) 1 0/94 (0%) 0 0/94 (0%) 0 0/291 (0%) 0
    Gastric dilatation 0/98 (0%) 0 0/99 (0%) 0 1/294 (0.3%) 1 0/94 (0%) 0 0/94 (0%) 0 0/291 (0%) 0
    Hiatus hernia 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 2
    General disorders
    Non-cardiac chest pain 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 1
    Infections and infestations
    Cellulitis 0/98 (0%) 0 0/99 (0%) 0 1/294 (0.3%) 1 0/94 (0%) 0 0/94 (0%) 0 0/291 (0%) 0
    Diverticulitis 0/98 (0%) 0 0/99 (0%) 0 1/294 (0.3%) 1 0/94 (0%) 0 0/94 (0%) 0 0/291 (0%) 0
    Herpes zoster 0/98 (0%) 0 1/99 (1%) 1 1/294 (0.3%) 1 0/94 (0%) 0 0/94 (0%) 0 0/291 (0%) 0
    Osteomyelitis 0/98 (0%) 0 0/99 (0%) 0 1/294 (0.3%) 1 0/94 (0%) 0 0/94 (0%) 0 0/291 (0%) 0
    Pneumonia 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 2/291 (0.7%) 2
    Sepsis 0/98 (0%) 0 0/99 (0%) 0 1/294 (0.3%) 1 0/94 (0%) 0 0/94 (0%) 0 0/291 (0%) 0
    Injury, poisoning and procedural complications
    Fall 0/98 (0%) 0 1/99 (1%) 1 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 0/291 (0%) 0
    Fibula fracture 0/98 (0%) 0 1/99 (1%) 1 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 0/291 (0%) 0
    Meniscus injury 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 1
    Tibia fracture 0/98 (0%) 0 1/99 (1%) 1 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 0/291 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 1
    Musculoskeletal and connective tissue disorders
    Lumbar spinal stenosis 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 1
    Muscular weakness 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 1/94 (1.1%) 1 0/291 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 0/98 (0%) 0 0/99 (0%) 0 1/294 (0.3%) 1 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 1
    Breast cancer 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 1/94 (1.1%) 1 0/291 (0%) 0
    Prostate cancer 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 1/94 (1.1%) 1 0/94 (0%) 0 0/291 (0%) 0
    Nervous system disorders
    Seizure 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 1
    Transient ischaemic attack 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 1
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 1/94 (1.1%) 1 0/94 (0%) 0 0/291 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 2
    Renal colic 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 1
    Reproductive system and breast disorders
    Menometrorrhagia 1/98 (1%) 1 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 0/291 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure 0/98 (0%) 0 0/99 (0%) 0 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 1/291 (0.3%) 1
    Surgical and medical procedures
    Abortion induced 0/98 (0%) 0 1/99 (1%) 1 0/294 (0%) 0 0/94 (0%) 0 0/94 (0%) 0 0/291 (0%) 0
    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 8/98 (8.2%) 14/99 (14.1%) 29/294 (9.9%) 27/94 (28.7%) 26/94 (27.7%) 67/291 (23%)
    Gastrointestinal disorders
    Diarrhoea 3/98 (3.1%) 3 5/99 (5.1%) 6 3/294 (1%) 3 2/94 (2.1%) 2 3/94 (3.2%) 3 6/291 (2.1%) 6
    Infections and infestations
    Influenza 1/98 (1%) 1 0/99 (0%) 0 6/294 (2%) 6 2/94 (2.1%) 2 5/94 (5.3%) 7 4/291 (1.4%) 5
    Upper respiratory tract infection 2/98 (2%) 2 4/99 (4%) 4 11/294 (3.7%) 11 9/94 (9.6%) 13 8/94 (8.5%) 8 24/291 (8.2%) 28
    Viral upper respiratory tract infection 2/98 (2%) 2 5/99 (5.1%) 5 10/294 (3.4%) 10 17/94 (18.1%) 22 14/94 (14.9%) 16 34/291 (11.7%) 40

    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.

    Results Point of Contact

    Name/Title Global Medical Services
    Organization AbbVie
    Phone 800-633-9110
    Email abbvieclinicaltrials@abbvie.com
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02684357
    Other Study ID Numbers:
    • M15-995
    • 2015-003622-13
    • 1311.28
    First Posted:
    Feb 18, 2016
    Last Update Posted:
    Aug 23, 2021
    Last Verified:
    Jul 1, 2021