A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- UCB Biopharma SRL
- Study ID
- NCT07219420
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Palmoplantar Pustulosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bimekizumab — DRUGStudy participants will receive bimekizumab at pre-specified time points.
- Placebo — DRUGStudy participants will receive matching placebo at pre-specified time points.
Study Details
The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).
Key Dates
- First listed
- Oct 21, 2025
- Start date
- Nov 14, 2025
- Status verified
- Aug 2026
- Primary completion
- Dec 27, 2027
- Completion
- Nov 22, 2029
Study Design
- Enrollment
- 320 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: BimekizumabSubjects randomized to this arm will receive the bimekizumab dosing regimen for the entire duration of the study.
- Placebo Comparator: PlaceboSubjects randomized to this arm will receive placebo during the initial treatment period before transitioning to bimekizumab in the maintenance treatment period.
Primary Outcome Measure
Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16 [ Time Frame: At Week 16 ]
Central Contacts
- UCB Cares+18445992273
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ppp001 50754 | Birmingham | Alabama | 35205 | - |
| Ppp001 50176 | Fremont | California | 94538 | - |
| Ppp001 50746 | Miami | Florida | 33126 | - |
| Ppp001 50757 | Auburn Hills | Michigan | 48326 | - |
| Ppp001 50745 | Columbus | Ohio | 43213 | - |
| Ppp001 50202 | Fairborn | Ohio | 45324 | - |
| Ppp001 50733 | Mayfield Heights | Ohio | 44124 | - |
| Ppp001 50744 | Oklahoma City | Oklahoma | 73170 | - |
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