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 (25) 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
RECRUITING
Apple Valley
Pa0019 111
RECRUITING
Covina
Pa0019 117
RECRUITING
Riverside
Pa0019 125
RECRUITING
San Leandro
Pa0019 126
RECRUITING
Temecula
Pa0019 120
RECRUITING
Whittier
Pa0019 128
RECRUITING
Whittier
Colorado
Pa0019 123
RECRUITING
Fort Collins
Florida
Pa0019 113
RECRUITING
South Miami
Michigan
Pa0019 134
RECRUITING
Lansing
New Jersey
Pa0019 140
RECRUITING
West Long Branch
New Mexico
Pa0019 131
RECRUITING
Albuquerque
Pennsylvania
Pa0019 115
RECRUITING
Duncansville
Tennessee
Pa0019 116
RECRUITING
Jackson
Texas
Pa0019 136
RECRUITING
Colleyville
Pa0019 135
RECRUITING
Mesquite
Pa0019 124
RECRUITING
Plano
Washington
Pa0019 121
RECRUITING
Bellevue
West Virginia
Pa0019 130
RECRUITING
Beckley
Other Locations
Bulgaria
Pa0019 205
RECRUITING
Pleven
Germany
Pa0019 301
RECRUITING
Hamburg
Poland
Pa0019 417
RECRUITING
Olsztyn
Pa0019 415
RECRUITING
Płońsk
Pa0019 406
RECRUITING
Poznan
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