A Randomised, Double-blind, Placebo-controlled, Proof-of-concept, Dose-ranging Study of BI 655066/ABBV-066/Risankizumab in Patients With Active Psoriatic Arthritis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 185
- Primary Endpoint
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 16
Study Overview
Brief Summary
The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066/ABBV-066/risankizumab in adult patients with psoriatic arthritis in order to select doses for further clinical trials.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
Intervention: placebo for risankizumab (Drug)
Risankizumab 150 mg Every 4 Weeks
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
Intervention: risankizumab (Drug)
Risankizumab 150 mg Weeks 0, 4, and 16
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
Intervention: risankizumab (Drug)
Risankizumab 150 mg Weeks 0 and 12
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
Intervention: risankizumab (Drug)
Risankizumab 75 mg Week 0
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
Intervention: risankizumab (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 16
Time Frame: Week 16
Response defined by ACR20 criteria (improvement from baseline) at Week 16: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient assessment of pain * Patient global assessment of disease activity * Investigator's global assessment of disease activity * Health Assessment Questionnaire Disability Index (HAQ-DI) * Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.
Secondary Outcomes
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 16(Week 16)
- Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16(Week 16)
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 16(Week 16)
- Tender Joint Count (TJC68): Change From Baseline to Week 16(Baseline, Week 16)
- Short Form-36 Health Status Survey (SF-36) Physical Component: Change From Baseline to Week 16(Baseline, Week 16)
- Modified Nail Psoriasis Severity Index (mNAPSI): Change From Baseline to Week 16(Baseline, Week 16)
- Swollen Joint Count (SJC): Change From Baseline to Week 16(Baseline, Week 16)
- Health Assessment Questionnaire Disability Index (HAQ-DI) Score: Change From Baseline to Week 16(Baseline, Week 16)
- SF-36 Mental Component: Change From Baseline to Week 16(Baseline, Week 16)
- Dactylitis Count: Change From Baseline to Week 16 in Participants With Dactylitis at Baseline(Baseline, Week 16)
- Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Change From Baseline to Week 16 in Participants With Enthesitis at Baseline(Baseline, Week 16)