An Open-label, Randomized, Parallel-group, Noninferiority Study to Evaluate the Pharmacokinetics of Bimekizumab Administered Intravenously or as a Subcutaneous Injection in Participants With Active Psoriatic Arthritis and/or Active Axial Spondyloarthritis
Status: Recruiting
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Be 18+ years old and legally able to consent
• Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment
• Weigh between 45-100 kg (females) or 50-100 kg (males).
• Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago
Locations
United States
Arizona
Pa0019 114
RECRUITING
Peoria
California
Pa0019 127
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Apple Valley
Pa0019 111
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Covina
Pa0019 117
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Riverside
Pa0019 125
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San Leandro
Pa0019 126
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Temecula
Pa0019 141
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Upland
Pa0019 120
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Whittier
Pa0019 128
RECRUITING
Whittier
Colorado
Pa0019 123
RECRUITING
Fort Collins
Florida
Pa0019 143
RECRUITING
Ormond Beach
Pa0019 113
RECRUITING
South Miami
Illinois
Pa0019 132
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Chicago
Michigan
Pa0019 134
RECRUITING
Lansing
New Jersey
Pa0019 140
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West Long Branch
New Mexico
Pa0019 131
RECRUITING
Albuquerque
Ohio
Pa0019 144
RECRUITING
Vandalia
Pennsylvania
Pa0019 115
RECRUITING
Duncansville
South Carolina
Pa0019 142
RECRUITING
Rock Hill
Tennessee
Pa0019 116
RECRUITING
Jackson
Pa0019 138
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Murfreesboro
Texas
Pa0019 129
RECRUITING
Baytown
Pa0019 136
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Colleyville
Pa0019 135
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Mesquite
Pa0019 124
RECRUITING
Plano
Washington
Pa0019 121
RECRUITING
Bellevue
Pa0019 145
RECRUITING
Spokane
West Virginia
Pa0019 130
RECRUITING
Beckley
Other Locations
Bulgaria
Pa0019 204
RECRUITING
Lovech
Pa0019 205
RECRUITING
Pleven
Pa0019 201
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Plovdiv
Pa0019 202
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Plovdiv
Pa0019 203
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Plovdiv
Germany
Pa0019 305
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Berlin
Pa0019 301
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Hamburg
Pa0019 302
RECRUITING
Ratingen
Pa0019 306
RECRUITING
Wetzlar
Poland
Pa0019 407
RECRUITING
Bialystok
Pa0019 418
RECRUITING
Bialystok
Pa0019 404
RECRUITING
Bytom
Pa0019 401
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Elblag
Pa0019 412
RECRUITING
Krakow
Pa0019 402
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Lodz
Pa0019 410
RECRUITING
Lublin
Pa0019 413
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Nowa Sól
Pa0019 417
RECRUITING
Olsztyn
Pa0019 415
RECRUITING
Płońsk
Pa0019 406
RECRUITING
Poznan
Pa0019 408
RECRUITING
Poznan
Pa0019 411
RECRUITING
Poznan
Pa0019 416
RECRUITING
Torun
Pa0019 405
RECRUITING
Warsaw
Pa0019 409
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Warsaw
Pa0019 414
RECRUITING
Warsaw
Pa0019 420
RECRUITING
Wroclaw
Slovakia
Pa0019 601
RECRUITING
Košice
Pa0019 603
RECRUITING
Piešťany
Contact Information
Primary
UCB Cares
ucbcares@ucb.com
+18445992273
Backup
UCB Cares
+18445992273
Time Frame
Start Date: 2025-12-10
Estimated Completion Date: 2028-09-14
Participants
Target number of participants: 392
Treatments
Experimental: Bimekizumab arm 1
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 or 2 during the PK Lead-In Phase and dosing regimen 1 or 2 during Treatment Period.
Experimental: Bimekizumab arm 2
Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the PK Lead-In Phase and dosing regimen 3 during Treatment Period.
Related Therapeutic Areas
Sponsors
Leads: UCB Biopharma SRL