Bimekizumab by IV infusion versus subcutaneous injection for adults with psoriatic arthritis or axial spondyloarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study compares two IV dosing regimens and one subcutaneous (SC) regimen of bimekizumab to measure safety and how the drug moves through the body over time (pharmacokinetics). Participants with active PsA or axSpA who meet weight and prior‑therapy requirements will be assigned to one of the dosing arms and undergo blood sampling and safety monitoring at scheduled visits. Key eligibility includes being 18+ years old, within the specified weight ranges, and bDMARD‑naïve or off prior biologics for the required washout. The primary objective is to demonstrate that IV administration is noninferior to SC administration in systemic exposure while tracking adverse events.

Why it matters

Who can join: the full rules

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)

Where it's running

• Pa0019 114
  Peoria, Arizona, United States Recruiting
• Pa0019 127
  Apple Valley, California, United States Recruiting
• Pa0019 111
  Covina, California, United States Recruiting
• Pa0019 119
  Fullerton, California, United States Recruiting
• Pa0019 117
  Riverside, California, United States Recruiting
• Pa0019 125
  San Leandro, California, United States Recruiting

+15 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: UCB Cares
• Email: ucbcares@ucb.com
• Phone: +18445992273

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.