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
UCB Biopharma SRL
Summary
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugBimekizumab regimen 1 iv
Participants will receive bimekizumab (BKZ) at pre-specified time points.
- DrugBimekizumab regimen 2 iv
Participants will receive bimekizumab (BKZ) at pre-specified time points.
- DrugBimekizumab regimen 3 sc
Participants will receive bimekizumab (BKZ) at pre-specified time points.
Locations (52)
- Pa0019 114Peoria, Arizona
- Pa0019 127Apple Valley, California
- Pa0019 111Covina, California
- Pa0019 117Riverside, California
- Pa0019 125San Leandro, California
- Pa0019 126Temecula, California