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

UCB

Status and phase: Enrolling; Phase 1

Conditions: Axial Spondyloarthritis; Psoriatic Arthritis

Treatments: Drug: Bimekizumab regimen 1 iv; Drug: Bimekizumab regimen 3 sc; Drug: Bimekizumab regimen 2 iv

Study type: Interventional

Funder types: Industry

Identifiers

NCT07290036

PA0019

2025-522782-30 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 392 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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392 participants in 2 patient groups

Bimekizumab arm 1

Experimental group

Description:

Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 or 2 during the PK Lead-In Phase and dosing regimen 1 or 2 during Treatment Period.

Treatment:

Drug: Bimekizumab regimen 2 iv

Drug: Bimekizumab regimen 1 iv

Bimekizumab arm 2

Experimental group

Description:

Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the PK Lead-In Phase and dosing regimen 3 during Treatment Period.

Treatment:

Drug: Bimekizumab regimen 3 sc