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A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
NCT07290036 · UCB Pharma
In plain English
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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
About this study
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Eligibility 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)
Study design
Enrollment target: 392 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-10
Estimated completion: 2028-09-14
Last updated: 2026-06-05
Interventions
Drug: Bimekizumab regimen 1 ivDrug: Bimekizumab regimen 2 ivDrug: Bimekizumab regimen 3 sc
Primary outcomes
- • Steady-state Trough Concentration (Ctrough,ss) at Week 16 (Week 16)
Sponsor
UCB Biopharma SRL · industry
Contacts & investigators
ContactUCB Cares · contact · ucbcares@ucb.com · +18445992273
ContactUCB Cares · contact · +18445992273
InvestigatorUCB Cares · study_director, 001 844 599 22733 (UCB)
All locations (61)
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Peoria, Arizona, United States
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Apple Valley, California, United States
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Covina, California, United States
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Riverside, California, United States
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San Leandro, California, United States
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Temecula, California, United States
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Upland, California, United States
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Whittier, California, United States
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Whittier, California, United States
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Fort Collins, Colorado, United States
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Ormond Beach, Florida, United States
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South Miami, Florida, United States
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Chicago, Illinois, United States
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Lansing, Michigan, United States
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West Long Branch, New Jersey, United States
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Albuquerque, New Mexico, United States
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Vandalia, Ohio, United States
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Duncansville, Pennsylvania, United States
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Rock Hill, South Carolina, United States
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Jackson, Tennessee, United States
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Murfreesboro, Tennessee, United States
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Baytown, Texas, United States
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Colleyville, Texas, United States
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Mesquite, Texas, United States
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Plano, Texas, United States
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Bellevue, Washington, United States
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Spokane, Washington, United States
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Beckley, West Virginia, United States
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Lovech, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Plovdiv, Bulgaria
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Plovdiv, Bulgaria
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Brno, Czechia
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Hlučín, Czechia
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Ostrava, Czechia
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Uherské Hradiště, Czechia
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Berlin, Germany
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Hamburg, Germany
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Ratingen, Germany
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Wetzlar, Germany
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Bialystok, Poland
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Bialystok, Poland
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Bytom, Poland
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Elblag, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Nowa Sól, Poland
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Olsztyn, Poland
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Poznan, Poland
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Poznan, Poland
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Poznan, Poland
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Płońsk, Poland
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Torun, Poland
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Warsaw, Poland
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Warsaw, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Košice, Slovakia
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Piešťany, Slovakia