Phase 2
Completed N=171
BI 655066 (Risankizumab) Compared to Placebo in Japanese Patients With Moderate to Severe Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT03000075 ↗Enrolled (actual)
171
Serious AEs
2.7%
Results posted
Feb 2019
Primary outcomePrimary: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) — 1.7; 75.9; 74.5 percentage of participants — p=< 0.001
Summary
This is a randomized double blind, double dummy, placebo controlled, parallel design study that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).
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 (Part A) |
1.7; 75.9; 74.5 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI90 at Week 52 (Part B) |
81.5; 85.2; 86.2; 92.7 | — |
| SECONDARY Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) |
10.3; 86.2; 92.7 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B) |
96.3; 88.9; 84.5; 94.5 | — |
| SECONDARY Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 (Part A) |
8.6; 89.7; 94.5 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI75 at Week 52 (Part B) |
100; 88.9; 94.8; 96.4 | — |
| SECONDARY Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 (Part A) |
0; 22.4; 32.7 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI100 at Week 52 (Part B) |
40.7; 44.4; 43.1; 41.8 | — |
| SECONDARY Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an American College of Rheumatology 20 Response (ACR20) at Week 16 (Part A) |
0; 40.0; 33.3 | 0.131 |
| SECONDARY Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B) |
100; 100; 60.0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 (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.
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
Data sourced from ClinicalTrials.gov (NCT03000075). 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.