A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- UCB Biopharma SRL
- Study ID
- NCT03248531
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Bimekizumab — DRUGBimekizumab in different dosages (dose 1 and 2).
- Adalimumab — DRUGAdalimumab in different dosages (dose 1, 2 and 3).
- Placebo — OTHERPlacebo will be provided matching Bimekizumab.
Study Details
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.
Key Dates
- Start date
- Sep 22, 2017
- Status verified
- Jan 2022
- Primary completion
- Nov 23, 2018
- Completion
- Feb 21, 2019
Study Design
- Enrollment
- 90 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: BimekizumabSubjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.
- Active Comparator: AdalimumabSubjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.
- Placebo Comparator: PlaceboSubjects will receive several placebo applications to keep the blinding.
Primary Outcome Measure
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [ Time Frame: Week 12 ]
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Hs0001 121 | Los Angeles | California | 90033 | - |
| Hs0001 119 | Coral Gables | Florida | 33134 | - |
| Hs0001 111 | Orange | Florida | 32073 | - |
| Hs0001 117 | Tampa | Florida | 33624 | - |
| Hs0001 112 | Sandy Springs | Georgia | 30328 | - |
| Hs0001 113 | Boston | Massachusetts | 02215 | - |
| Hs0001 115 | Las Vegas | Nevada | 89074 | - |
| Hs0001 126 | Manhasset | New York | 11030 | - |
| Hs0001 125 | Chapel Hill | North Carolina | 27599 | - |
| Hs0001 123 | Hershey | Pennsylvania | 17033 | - |
| Hs0001 120 | Nashville | Tennessee | 37215 | - |
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