Health Trials

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

ConditionsPsoriatic ArthritisAxial Spondyloarthritis
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 groups

Locations

62
Bulgaria
Pa0019 204 Lovech Bulgaria
Pa0019 205 Pleven Bulgaria
Pa0019 201 Plovdiv Bulgaria
Pa0019 202 Plovdiv Bulgaria

Sponsors and collaborators

UCB Biopharma SRL

Lead sponsor

Source ClinicalTrials.gov