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A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults

RECRUITINGPhase 1Sponsored by UCB Biopharma SRL
Actively Recruiting
PhasePhase 1
SponsorUCB Biopharma SRL
Started2025-12-10
Est. completion2028-04-04
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations17 sites

Summary

To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

1. Be 18+ years old and legally able to consent
2. Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment
3. Weigh between 45-100 kg (females) or 50-100 kg (males).
4. Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago

Exclusion Criteria:

1. Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro)
2. Severe psychiatric issues or substance abuse in the past year
3. Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB)
4. Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD))
5. Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year)
6. Recent use of glucagon-like peptide-1 (GLP-1) agonists (within 28 weeks)

Conditions3

ArthritisAxial SpondyloarthritisPsoriatic Arthritis

Locations17 sites

Pa0019 114
Peoria, Arizona, 85381-5025
Pa0019 127
Apple Valley, California, 92307
Pa0019 111
Covina, California, 91722
Pa0019 117
Riverside, California, 92518
Pa0019 125
San Leandro, California, 94578

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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