A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUCB Biopharma SRL
About this trial
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Eligibility criteria
Qualifiers
Be 18+ years old and legally able to consent
Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment
Weigh between 45-100 kg (females) or 50-100 kg (males).
Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago
Disqualifiers
Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro)
Severe psychiatric issues or substance abuse in the past year
Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB)
Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD))
Trial design
Treatments tested in this trial
- Bimekizumab regimen 1 iv
- Bimekizumab regimen 2 iv
- Bimekizumab regimen 3 sc
Treatment groups
392 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov