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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. completion2028-05-18
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations28 sites
View on ClinicalTrials.gov →
NCT07290036
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
Interventions3
Locations28 sites
Pa0019 114
Pa0019 127
Pa0019 111
Pa0019 117
Pa0019 125
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Actively Recruiting
PhasePhase 1
SponsorUCB Biopharma SRL
Started2025-12-10
Est. completion2028-05-18
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations28 sites
View on ClinicalTrials.gov →
NCT07290036