Phase 3
Completed N=506
BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT02684370 ↗Enrolled (actual)
506
Serious AEs
4.1%
Results posted
Jun 2019
Primary outcomePrimary: 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) — 4.9; 75.3 percentage of participants — p=<0.001
◆ Published Evidence
Established
53citations · ~9 / year
Effect of Risankizumab on Patient-Reported Outcomes in Moderate to Severe Psoriasis: The UltIMMa-1 and UltIMMa-2 Randomized Clinical Trials.
Summary
The purpose of this study is to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) for the treatment of moderate to severe chronic plaque psoriasis in adult patients.
Linked Publications (5)
-
Effect of Risankizumab on Patient-Reported Outcomes in Moderate to Severe Psoriasis: The UltIMMa-1 and UltIMMa-2 Randomized Clinical Trials.
-
Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials.
-
Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis.
-
Switching to risankizumab from ustekinumab or adalimumab in plaque psoriasis patients improves PASI and DLQI outcomes for sub-optimal responders.
-
Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
4.9; 75.3 | <0.001 sig |
| PRIMARY Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) |
7.8; 87.8 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) |
2.0; 36.8 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) |
0; 35.9 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) |
7.8; 65.8 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) |
2.0; 29.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI90 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) |
42.0; 75.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) |
63.0; 87.8 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) |
12.0; 35.9 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) |
14.0; 36.8 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI90 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B) |
44.0; 81.9 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI100 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B) |
21.0; 56.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B) |
21.0; 57.6 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI75 at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) |
70.0; 86.8 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) |
65.0; 82.2 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) |
43.0; 65.8 | < 0.001 sig |
| SECONDARY PSS Total Score: Change From Baseline to Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) |
0.157; -5.608 | <0.001 sig |
Eligibility Criteria
Inclusion criteria
- Male or female patients with age ≥18 years at screening.
- Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.
- Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomisation):
- Have an involved body surface area (BSA) ≥10% and
- Have a Psoriasis Area and Severity Index (PASI) score ≥12 and
- Have a static Physician Global Assessment (sPGA) score of ≥3.
- Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator.
- Must be a candidate for treatment with Stelara® (ustekinumab) according to local label.
Exclusion criteria
- Patients with:
- non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
- current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment
- Previous exposure to BI 655066.
- Previous exposure to ustekinumab (Stelara®).
Data sourced from ClinicalTrials.gov (NCT02684370) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.