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NCT07290036 | RECRUITING | Psoriatic Arthritis

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

UCB Biopharma SRL

Brief Summary:

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

Condition or disease

Psoriatic Arthritis

Axial Spondyloarthritis

Intervention/treatment

Bimekizumab regimen 1 iv

Bimekizumab regimen 2 iv

Bimekizumab regimen 3 sc

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 392 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-12-10
Estimated Primary Completion Date : 2028-04-04
Estimated Study Completion Date : 2028-07-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults

Location Details

NCT07290036

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Pa0019 114

Peoria, arizona, United States, 85381-5025

RECRUITING

United States, California

Pa0019 111

Covina, California, United States, 91722

RECRUITING

United States, California

Pa0019 120

Destination, California, United States, 91042

RECRUITING

United States, California

Pa0019 128

Whittier, California, United States, 90602

RECRUITING

United States, Florida

Pa0019 113

South Miami, florida, United States, 33143