PA0019

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

Brief summary

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

Medical Condition

Psoriatic Arthritis

Min. Age

18
Years

Max. Age

-

Who Can Join?

All

Status

Recruiting
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)

Study Medication Description

Study Medication:

Bimzelx

Other Descriptive Name:

bimekizumab

Placebo

No

Comparator:

No

Study Dates

December 2025

Actual Start Date of Enrollment

July 2028

Planned Study Completion Date

General Information

Study ID:
PA0019
EudraCT Number:
2025-522782-30
CT.gov Number:
NCT07290036
Phase:
Phase 1

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