Psoriatic arthritis
Conditions
Brief summary
American College of Rheumatology 50 (ACR50) at Week 16
Detailed description
• Minimal Disease Activity (MDA) at Week 16, • Composite endpoint composed of ACR50 and Psoriasis Area and Severity Index 100% (PASI100) response at Week 16 in the subgroup of study participants with PSO involving at least 3% body surface area (BSA) at Baseline, • Treatment-emergent adverse events (TEAEs), • Treatment-emergent serious AEs, • TEAEs leading to withdrawal from investigational medicinal product (IMP), • American College of Rheumatology 50 (ACR50) at Week 4
Interventions
DRUGbimekizumab
DRUGPlacebo matching test
and comparator. 0.9%
sodium chloride solution
for injection
(unauthorized).
Sponsors
UCB Biopharma
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| American College of Rheumatology 50 (ACR50) at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Minimal Disease Activity (MDA) at Week 16, • Composite endpoint composed of ACR50 and Psoriasis Area and Severity Index 100% (PASI100) response at Week 16 in the subgroup of study participants with PSO involving at least 3% body surface area (BSA) at Baseline, • Treatment-emergent adverse events (TEAEs), • Treatment-emergent serious AEs, • TEAEs leading to withdrawal from investigational medicinal product (IMP), • American College of Rheumatology 50 (ACR50) at Week 4 | — |
Countries
Bulgaria, Czechia, Germany, Hungary, Poland, Spain
Outcome results
None listed