A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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
UCB Biopharma SRL
392 participants
Dec 10, 2025
INTERVENTIONAL
Conditions
Summary
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria6
- Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro)
- Severe psychiatric issues or substance abuse in the past year
- Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB)
- Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD))
- Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year)
- Recent use of glucagon-like peptide-1 (GLP-1) agonists (within 28 weeks)
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Interventions
Participants will receive bimekizumab (BKZ) at pre-specified time points.
Participants will receive bimekizumab (BKZ) at pre-specified time points.
Participants will receive bimekizumab (BKZ) at pre-specified time points.
Locations(52)
View Full Details on ClinicalTrials.gov
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NCT07290036