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BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

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ClinicalTrials.gov Identifier: NCT02672852
Recruitment Status : Completed
First Posted : February 3, 2016
Results First Posted : May 27, 2019
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Risankizumab
Drug: Placebo
Enrollment 507
Recruitment Details  
Pre-assignment Details Part A1: double-blind (DB) risankizumab or placebo (Weeks 0,4). Part A2 (Week 16) DB placebo to DB risankizumab; risankizumab continued risankizumab. Part B (Week 28) risankizumab responders rerandomized to DB risankizumab/placebo; risankizumab nonresponders continued risankizumab. Week 32: rerandomized relapsed switch risankizumab.
Arm/Group Title Placebo (Part A1) Risankizumab (Part A1) Placebo/Risankizumab Part A2/Part B Risankizumab/Risankizumab Part A2 Risankizumab/Placebo (Part B; Rerandomized Responders) Risankizumab/Risankizumab (Part B; Rerandomized Responders) Risankizumab/Risankizumab Part B (Nonresponders)
Hide Arm/Group Description Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1). Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1). Participants randomized at Baseline to receive double-blind (DB) placebo then received DB risankizumab 150 mg at Weeks 16 (Part A2) and at Week 28 and every 12 weeks up to 88 weeks (Part B). Participants randomized at Baseline to receive double-blind (DB) risankizumab then received DB risankizumab 150 mg at Weeks 16 (Part A2). Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B). Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B). Participants who received risankizumab in Part A and were nonresponders (sPGA ≥2) at Week 28 received risankizumab 150 mg at Week 28 and every 12 weeks up to 88 weeks (Part B).
Period Title: Part A1
Started 100 407 0 0 0 0 0
Completed 97 403 0 0 0 0 0
Not Completed 3 4 0 0 0 0 0
Reason Not Completed
Disease Worsening             1             0             0             0             0             0             0
Adverse Event             0             1             0             0             0             0             0
Lost to Follow-up             1             2             0             0             0             0             0
Withdrawal by Subject             1             1             0             0             0             0             0
Period Title: Part A2
Started 0 [1] 0 [1] 93 [1] 403 [1] 0 0 0
Completed 0 0 83 399 0 0 0
Not Completed 0 0 10 4 0 0 0
Reason Not Completed
Disease worsening             0             0             1             0             0             0             0
Adverse Event             0             0             3             0             0             0             0
Lost to Follow-up             0             0             2             0             0             0             0
Withdrawal by Subject             0             0             1             0             0             0             0
Not specified             0             0             3             0             0             0             0
Not entered in Part B             0             0             0             4             0             0             0
[1]
Participants that completed Part A1 continued on to Part A2.
Period Title: Part B
Started 0 0 0 [1] 0 [1] 225 [1] 111 [1] 63 [1]
Completed 0 0 0 0 209 100 51
Not Completed 0 0 0 0 16 11 12
Reason Not Completed
Disease worsening             0             0             0             0             1             0             1
Worsening pre-existing condition             0             0             0             0             0             1             0
Other adverse event             0             0             0             0             3             5             1
Lost to Follow-up             0             0             0             0             3             4             1
Withdrawal by Subject             0             0             0             0             5             0             7
Not specified             0             0             0             0             4             1             2
[1]
Participants that completed Part A2 continued on to Part B.
Arm/Group Title Placebo (Part A1) Risankizumab (Part A1) Total
Hide Arm/Group Description Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1). Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1). Total of all reporting groups
Overall Number of Baseline Participants 100 407 507
Hide Baseline Analysis Population Description
Intent to Treat (ITT) Population in Part A1 (ITT_A1): All participants who were randomized at Baseline
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 407 participants 507 participants
47.9  (13.78) 49.6  (13.17) 49.2  (13.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 407 participants 507 participants
Female 27 124 151
Male 73 283 356
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 407 participants 507 participants
Hispanic or Latino 11 45 56
Not Hispanic or Latino 89 362 451
Unknown or Not Reported 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 407 participants 507 participants
American Indian or Alaska Native 0 0 0
Asian 15 64 79
Native Hawaiian or Other Pacific Islander 1 3 4
Black or African American 2 18 20
White 82 320 402
More than one race 0 2 2
Unknown or Not Reported 0 0 0
1.Primary Outcome
Title Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16
Hide 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 Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) Population in Part A1(ITT_A1): all participants who were randomized at Baseline.
Arm/Group Title Placebo (Part A1) Risankizumab (Part A1)
Hide Arm/Group Description:
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
Overall Number of Participants Analyzed 100 407
Measure Type: Number
Unit of Measure: percentage of participants
2.0 73.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Part A1), Risankizumab (Part A1)
Comments Across strata, P value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 70.8
Confidence Interval (2-Sided) 95%
65.7 to 76.0
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Part A1(ITT_A1)
Arm/Group Title Placebo (Part A1) Risankizumab (Part A1)
Hide Arm/Group Description:
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
Overall Number of Participants Analyzed 100 407
Measure Type: Number
Unit of Measure: percentage of participants
7.0 83.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Part A1), Risankizumab (Part A1)
Comments Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 76.5
Confidence Interval (2-Sided) 95%
70.4 to 82.5
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Part B for re-randomized participants (ITT_B_R): All participants who were randomized to Arm 1 at Baseline and re randomized at Week 28.
Arm/Group Title Risankizumab/Placebo (Part B; Rerandomized Responders) Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Hide Arm/Group Description:
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B).
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B).
Overall Number of Participants Analyzed 225 111
Measure Type: Number
Unit of Measure: percentage of participants
61.3 87.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risankizumab/Placebo (Part B; Rerandomized Responders), Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Comments Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 25.9
Confidence Interval (2-Sided) 95%
17.3 to 34.6
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Part A1 (ITT_A1)
Arm/Group Title Placebo (Part A1) Risankizumab (Part A1)
Hide Arm/Group Description:
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
Overall Number of Participants Analyzed 100 407
Measure Type: Number
Unit of Measure: percentage of participants
8.0 88.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Part A1), Risankizumab (Part A1)
Comments Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 80.6
Confidence Interval (2-Sided) 95%
74.5 to 86.6
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Part A1 (ITT_A1)
Arm/Group Title Placebo (Part A1) Risankizumab (Part A1)
Hide Arm/Group Description:
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
Overall Number of Participants Analyzed 100 407
Measure Type: Number
Unit of Measure: percentage of participants
1.0 47.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Part A1), Risankizumab (Part A1)
Comments Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 45.5
Confidence Interval (2-Sided) 95%
40.3 to 50.8
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants Achieving an sPGA Score of Clear at Week 16
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Part A1 (ITT_A1)
Arm/Group Title Placebo (Part A1) Risankizumab (Part A1)
Hide Arm/Group Description:
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
Overall Number of Participants Analyzed 100 407
Measure Type: Number
Unit of Measure: percentage of participants
1.0 46.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Part A1), Risankizumab (Part A1)
Comments Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 44.8
Confidence Interval (2-Sided) 95%
39.5 to 50.0
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
Hide Description The 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 1 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. NRI was used for missing data.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Part A1 (ITT_A1)
Arm/Group Title Placebo (Part A1) Risankizumab (Part A1)
Hide Arm/Group Description:
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
Overall Number of Participants Analyzed 100 407
Measure Type: Number
Unit of Measure: percentage of participants
3.0 65.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Part A1), Risankizumab (Part A1)
Comments Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 62.1
Confidence Interval (2-Sided) 95%
56.4 to 67.9
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104
Hide 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 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Part B for re-randomized participants (ITT_B_R)
Arm/Group Title Risankizumab/Placebo (Part B; Rerandomized Responders) Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Hide Arm/Group Description:
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B).
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B).
Overall Number of Participants Analyzed 225 111
Measure Type: Number
Unit of Measure: percentage of participants
7.1 81.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risankizumab/Placebo (Part B; Rerandomized Responders), Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Comments Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 73.9
Confidence Interval (2-Sided) 95%
66.0 to 81.9
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Part B for re-randomized participants (ITT_B_R)
Arm/Group Title Risankizumab/Placebo (Part B; Rerandomized Responders) Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Hide Arm/Group Description:
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B).
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B).
Overall Number of Participants Analyzed 225 111
Measure Type: Number
Unit of Measure: percentage of participants
71.6 92.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risankizumab/Placebo (Part B; Rerandomized Responders), Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Comments Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 21.2
Confidence Interval (2-Sided) 95%
13.7 to 28.7
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Part B for re-randomized participants (ITT_B_R)
Arm/Group Title Risankizumab/Placebo (Part B; Rerandomized Responders) Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Hide Arm/Group Description:
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B).
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B).
Overall Number of Participants Analyzed 225 111
Measure Type: Number
Unit of Measure: percentage of participants
52.4 85.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risankizumab/Placebo (Part B; Rerandomized Responders), Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Comments Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 33.1
Confidence Interval (2-Sided) 95%
24.0 to 42.2
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52
Hide 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 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Part B for re-randomized participants (ITT_B_R)
Arm/Group Title Risankizumab/Placebo (Part B; Rerandomized Responders) Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Hide Arm/Group Description:
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B).
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B).
Overall Number of Participants Analyzed 225 111
Measure Type: Number
Unit of Measure: percentage of participants
30.2 64.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risankizumab/Placebo (Part B; Rerandomized Responders), Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Comments Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 33.7
Confidence Interval (2-Sided) 95%
23.2 to 44.2
Estimation Comments [Not Specified]
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 103 weeks).
Adverse Event Reporting Description TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at [up to Week 103]).
 
Arm/Group Title Placebo (Part A1) Risankizumab (Part A1) Risankizumab/Placebo (Part B; Rerandomized Responders) Risankizumab/Risankizumab (Part B; Rerandomized Responders) Any Risankizumab
Hide Arm/Group Description All participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1). All participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1). Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B). Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B). Participants who received at least one dose of risankizumab during the study.
All-Cause Mortality
Placebo (Part A1) Risankizumab (Part A1) Risankizumab/Placebo (Part B; Rerandomized Responders) Risankizumab/Risankizumab (Part B; Rerandomized Responders) Any Risankizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)      0/407 (0.00%)      0/225 (0.00%)      2/111 (1.80%)      4/500 (0.80%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Part A1) Risankizumab (Part A1) Risankizumab/Placebo (Part B; Rerandomized Responders) Risankizumab/Risankizumab (Part B; Rerandomized Responders) Any Risankizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/100 (8.00%)      8/407 (1.97%)      17/225 (7.56%)      13/111 (11.71%)      55/500 (11.00%)    
Blood and lymphatic system disorders           
Disseminated intravascular coagulation  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Cardiac disorders           
Acute myocardial infarction  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 2/500 (0.40%)  2
Angina unstable  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Aortic valve disease mixed  1  0/100 (0.00%)  0 1/407 (0.25%)  1 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Atrial fibrillation  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Cardiac arrest  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Cardiac failure congestive  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Coronary artery disease  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Intracardiac thrombus  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Myocardial infarction  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Ventricular arrhythmia  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Congenital, familial and genetic disorders           
Benign familial pemphigus  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Huntington's disease  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Ear and labyrinth disorders           
Vertigo  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 0/500 (0.00%)  0
Eye disorders           
Amaurosis fugax  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 0/500 (0.00%)  0
Diabetic retinopathy  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 0/500 (0.00%)  0
Retinal detachment  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Gastrointestinal disorders           
Abdominal pain  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Alcoholic pancreatitis  1  1/100 (1.00%)  1 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 0/500 (0.00%)  0
Haemorrhoids  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Inguinal hernia  1  1/100 (1.00%)  1 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 0/500 (0.00%)  0
Intestinal obstruction  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Pancreatitis acute  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
General disorders           
Death  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Hepatobiliary disorders           
Bile duct stone  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Cholecystitis acute  1  0/100 (0.00%)  0 1/407 (0.25%)  1 0/225 (0.00%)  0 0/111 (0.00%)  0 2/500 (0.40%)  2
Hepatic cirrhosis  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Liver injury  1  1/100 (1.00%)  1 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 0/500 (0.00%)  0
Infections and infestations           
Abdominal abscess  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 0/500 (0.00%)  0
Abscess neck  1  0/100 (0.00%)  0 1/407 (0.25%)  1 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Appendicitis  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Bronchitis  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Cellulitis  1  1/100 (1.00%)  1 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 2/500 (0.40%)  2
Diverticulitis  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 0/500 (0.00%)  0
Meningitis bacterial  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Nasopharyngitis  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Periorbital cellulitis  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 0/500 (0.00%)  0
Sepsis  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 2/500 (0.40%)  2
Viral infection  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Injury, poisoning and procedural complications           
Burns second degree  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Fall  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 2/500 (0.40%)  4
Femur fracture  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 1/500 (0.20%)  1
Hand fracture  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Incisional hernia  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Ligament sprain  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Muscle strain  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Open globe injury  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Thoracic vertebral fracture  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Metabolism and nutrition disorders           
Dehydration  1  0/100 (0.00%)  0 1/407 (0.25%)  1 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Hypokalaemia  1  0/100 (0.00%)  0 1/407 (0.25%)  1 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  2
Arthropathy  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Bursitis  1  0/100 (0.00%)  0 1/407 (0.25%)  1 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Gouty tophus  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Jaw cyst  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 0/500 (0.00%)  0
Osteoarthritis  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 2/500 (0.40%)  2
Psoriatic arthropathy  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Rotator cuff syndrome  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
B-cell lymphoma  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 0/500 (0.00%)  0
Basal cell carcinoma  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  2 0/111 (0.00%)  0 3/500 (0.60%)  3
Breast cancer  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Breast cancer stage I  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 0/500 (0.00%)  0
Gastric cancer  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Hepatic cancer metastatic  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Intestinal adenocarcinoma  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Invasive ductal breast carcinoma  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Malignant melanoma in situ  1  0/100 (0.00%)  0 1/407 (0.25%)  1 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Metastases to lymph nodes  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Oesophageal carcinoma  1  0/100 (0.00%)  0 1/407 (0.25%)  1 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Prostate cancer  1  0/100 (0.00%)  0 0/407 (0.00%)  0 2/225 (0.89%)  2 1/111 (0.90%)  1 2/500 (0.40%)  2
Squamous cell carcinoma of skin  1  0/100 (0.00%)  0 1/407 (0.25%)  1 1/225 (0.44%)  1 0/111 (0.00%)  0 2/500 (0.40%)  2
Nervous system disorders           
Basal ganglia infarction  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Carotid artery occlusion  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Cerebral infarction  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Cerebrovascular accident  1  1/100 (1.00%)  1 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 0/500 (0.00%)  0
Dementia  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Encephalitis autoimmune  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Epilepsy  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Hemiplegia  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 2/500 (0.40%)  2
Ischaemic stroke  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Seizure  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  2
Tension headache  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 0/500 (0.00%)  0
Transient ischaemic attack  1  1/100 (1.00%)  1 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 0/500 (0.00%)  0
Psychiatric disorders           
Alcoholism  1  1/100 (1.00%)  1 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 0/500 (0.00%)  0
Anxiety  1  1/100 (1.00%)  1 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 0/500 (0.00%)  0
Delirium tremens  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Insomnia  1  1/100 (1.00%)  1 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 0/500 (0.00%)  0
Somatic symptom disorder  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 0/500 (0.00%)  0
Suicidal ideation  1  1/100 (1.00%)  1 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 0/500 (0.00%)  0
Reproductive system and breast disorders           
Benign prostatic hyperplasia  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Cervical dysplasia  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Menometrorrhagia  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 1/111 (0.90%)  1 1/500 (0.20%)  1
Menorrhagia  1  0/100 (0.00%)  0 0/407 (0.00%)  0 1/225 (0.44%)  1 0/111 (0.00%)  0 0/500 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Acute respiratory failure  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Chylothorax  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Pneumothorax  1  0/100 (0.00%)  0 1/407 (0.25%)  1 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Pulmonary embolism  1  0/100 (0.00%)  0 1/407 (0.25%)  1 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Skin and subcutaneous tissue disorders           
Skin ulcer  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Surgical and medical procedures           
Alcohol detoxification  1  0/100 (0.00%)  0 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 1/500 (0.20%)  1
Vascular disorders           
Deep vein thrombosis  1  1/100 (1.00%)  1 0/407 (0.00%)  0 0/225 (0.00%)  0 0/111 (0.00%)  0 0/500 (0.00%)  0
1
Term from vocabulary, MedDRA version 21
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Part A1) Risankizumab (Part A1) Risankizumab/Placebo (Part B; Rerandomized Responders) Risankizumab/Risankizumab (Part B; Rerandomized Responders) Any Risankizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/100 (17.00%)      52/407 (12.78%)      92/225 (40.89%)      52/111 (46.85%)      242/500 (48.40%)    
Infections and infestations           
Influenza  1  1/100 (1.00%)  1 3/407 (0.74%)  3 8/225 (3.56%)  10 7/111 (6.31%)  8 22/500 (4.40%)  24
Nasopharyngitis  1  6/100 (6.00%)  6 21/407 (5.16%)  21 45/225 (20.00%)  53 23/111 (20.72%)  36 116/500 (23.20%)  170
Upper respiratory tract infection  1  5/100 (5.00%)  5 6/407 (1.47%)  6 23/225 (10.22%)  29 16/111 (14.41%)  19 77/500 (15.40%)  97
Musculoskeletal and connective tissue disorders           
Arthralgia  1  2/100 (2.00%)  2 7/407 (1.72%)  7 13/225 (5.78%)  16 10/111 (9.01%)  10 35/500 (7.00%)  37
Back pain  1  0/100 (0.00%)  0 2/407 (0.49%)  2 12/225 (5.33%)  13 4/111 (3.60%)  7 28/500 (5.60%)  31
Nervous system disorders           
Headache  1  0/100 (0.00%)  0 14/407 (3.44%)  15 7/225 (3.11%)  9 8/111 (7.21%)  15 34/500 (6.80%)  47
Skin and subcutaneous tissue disorders           
Psoriasis  1  5/100 (5.00%)  6 2/407 (0.49%)  2 8/225 (3.56%)  8 0/111 (0.00%)  0 4/500 (0.80%)  4
1
Term from vocabulary, MedDRA version 21
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02672852     History of Changes
Other Study ID Numbers: M15-992
2014-005102-38 ( EudraCT Number )
1311.4 ( Other Identifier: Boehringer Ingelheim )
First Submitted: February 1, 2016
First Posted: February 3, 2016
Results First Submitted: May 3, 2019
Results First Posted: May 27, 2019
Last Update Posted: October 9, 2019