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

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

Phase 1 Interventional UCB Pharma · NCT07290036

This trial tests whether bimekizumab given by intravenous (IV) infusion behaves the same in the body as the usual subcutaneous injection in adults with psoriatic arthritis or axial spondyloarthritis.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment392 (estimated)
Ages18 Years and up
SexAll
SponsorUCB Pharma Industry-sponsored
Drugs / interventionsbimekizumab
Locations52 sites (Peoria, Arizona and 51 other locations)
Trial IDNCT07290036 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older with active psoriatic arthritis or axial spondyloarthritis who meet the study weight criteria and are bDMARD‑naïve or have completed the required biologic washout are ideal candidates.

Not a fit: Patients with serious organ dysfunction, recent or chronic infections including TB/NTM, other inflammatory diseases (e.g., RA, lupus, IBD), recent live vaccines or recent GLP‑1 agonist use, or severe psychiatric/substance use problems are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, IV dosing could offer an alternative way to receive bimekizumab with similar drug exposure and safety, giving patients and clinicians more flexibility.

How similar studies have performed: Bimekizumab has demonstrated efficacy in PsA and axSpA in prior trials using subcutaneous dosing, but direct IV versus SC pharmacokinetic noninferiority comparisons in this population are relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Peoria, Arizona and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Psoriatic ArthritisAxial SpondyloarthritisBimekizumab, BKZ, Phase 1B
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.