A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- UCB Biopharma SRL
- Study ID
- NCT03896581
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bimekizumab — DRUGSubjects will receive bimekizumab at pre-specified time-points.
- Placebo — OTHERSubjects will receive placebo at pre-specified time-points.
Study Details
This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFα-IR) subjects with active Psoriatic Arthritis (PsA).
Key Dates
- Start date
- Mar 28, 2019
- Status verified
- Jan 2026
- Primary completion
- Dec 8, 2021
- Completion
- Feb 14, 2022
Study Design
- Enrollment
- 400 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Bimekizumab dosage regimenSubjects randomized to this arm will receive assigned bimekizumab dosage regimen.
- Placebo Comparator: PlaceboSubjects randomized to this arm will receive placebo.
Primary Outcome Measure
Percentage of Participants With American College of Rheumatology 50 (ACR50) Response [ Time Frame: From Baseline to Week 16 ]
Locations (33)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Pa0011 50017 | Phoenix | Arizona | 85037 | - |
| Pa0011 50035 | San Diego | California | 92128 | - |
| Pa0011 50004 | Tustin | California | 92780 | - |
| Pa0011 50033 | Palm Harbor | Florida | 34684 | - |
| Pa0011 50037 | Tampa | Florida | 33613 | - |
| Pa0011 50039 | Atlanta | Georgia | 30342 | - |
| Pa0011 50024 | Boise | Idaho | 83702 | - |
| Pa0011 50028 | Lexington | Kentucky | 40504 | - |
| Pa0011 50023 | Baton Rouge | Louisiana | 70836 | - |
| Pa0011 50015 | Hagerstown | Maryland | 21740 | - |
| Pa0011 50026 | Wheaton | Maryland | 20902 | - |
| Pa0011 50047 | Boston | Massachusetts | 02115-5817 | - |
| Pa0011 50019 | Lansing | Michigan | 48911 | - |
| Pa0011 50016 | St Louis | Missouri | 63141 | - |
| Pa0011 50005 | Freehold | New Jersey | 07728 | - |
| Pa0011 50029 | Albuquerque | New Mexico | 87102 | - |
| Pa0011 50010 | Brooklyn | New York | 11201 | - |
| Pa0011 50011 | New York | New York | 10003 | - |
| Pa0011 50034 | Rochester | New York | 14642 | - |
| Pa0011 50125 | Charlotte | North Carolina | 28210 | - |
| Pa0011 50031 | Salisbury | North Carolina | 28144 | - |
| Pa0011 50040 | Vandalia | Ohio | 45377 | - |
| Pa0011 50020 | Duncansville | Pennsylvania | 16635 | - |
| Pa0011 50064 | Philadelphia | Pennsylvania | 19104 | - |
| Pa0011 50006 | Wyomissing | Pennsylvania | 19610 | - |
| Pa0011 50008 | Johnston | Rhode Island | 02919 | - |
| Pa0011 50021 | Summerville | South Carolina | 29486 | - |
| Pa0011 50001 | Jackson | Tennessee | 38305 | - |
| Pa0011 50012 | Memphis | Tennessee | 38119-5214 | - |
| Pa0011 50002 | Austin | Texas | 78731 | - |
| Pa0011 50036 | Mesquite | Texas | 75150 | - |
| Pa0011 50009 | Waco | Texas | 76710 | - |
| Pa0011 50050 | Beckley | West Virginia | 25801 | - |
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