Phase 1: testing Bimekizumab regimen 1 iv for Psoriatic Arthritis
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Official registry: https://clinicaltrials.gov/study/NCT07290036 · UCB Biopharma SRL · enrollment listed as 392
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Bimekizumab regimen 1 iv, Bimekizumab regimen 2 iv, or Bimekizumab regimen 3 sc. The registry lists allocation as randomized. To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
They plan to enroll about 392 people at 65 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: Bimekizumab regimen 1 iv, Bimekizumab regimen 2 iv, Bimekizumab regimen 3 sc
Primary outcome (registry wording): Steady-state Trough Concentration (Ctrough,ss) at Week 16
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- 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))
- Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year)
- Recent use of glucagon-like peptide-1 (GLP-1) agonists (within 28 weeks)
Public study contact (from the registry)
UCB Cares
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
65 listed- Pa0019 114 — Peoria, Arizona (recruiting)
- Pa0019 127 — Apple Valley, California (recruiting)
- Pa0019 111 — Covina, California (recruiting)
- Pa0019 119 — Fullerton, California (recruiting)
- Pa0019 117 — Riverside, California (recruiting)
- Pa0019 125 — San Leandro, California (recruiting)
- Pa0019 126 — Temecula, California (recruiting)
- Pa0019 141 — Upland, California (recruiting)
- Pa0019 120 — Whittier, California (recruiting)
- Pa0019 128 — Whittier, California (recruiting)
- Pa0019 123 — Fort Collins, Colorado (recruiting)
- Pa0019 143 — Ormond Beach, Florida (recruiting)
+ 35 sites outside the US on the same record
FAQ about this NCT record
Is NCT07290036 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07290036?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07290036?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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