A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Recruiting · NCT07290036 · Interventional (participants receive a specific treatment) · Lead sponsor: UCB Biopharma SRL
View the official record on ClinicalTrials.gov →Interventions studied
Bimekizumab regimen 1 ivBimekizumab regimen 2 ivBimekizumab regimen 3 sc
What this trial is about
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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)
Where it is running
60 locations listed across 15 US states.
- Pa0019 114 - Peoria, Arizona, United States
- Pa0019 127 - Apple Valley, California, United States
- Pa0019 111 - Covina, California, United States
- Pa0019 119 - Fullerton, California, United States
- Pa0019 117 - Riverside, California, United States
- Pa0019 125 - San Leandro, California, United States
- Pa0019 126 - Temecula, California, United States
- Pa0019 141 - Upland, California, United States
- Pa0019 120 - Whittier, California, United States
- Pa0019 128 - Whittier, California, United States
- Pa0019 123 - Fort Collins, Colorado, United States
- Pa0019 143 - Ormond Beach, Florida, United States
- Pa0019 113 - South Miami, Florida, United States
- Pa0019 133 - Zephyrhills, Florida, United States
- Pa0019 132 - Chicago, Illinois, United States
- Pa0019 134 - Lansing, Michigan, United States
- Pa0019 140 - West Long Branch, New Jersey, United States
- Pa0019 131 - Albuquerque, New Mexico, United States
- Pa0019 144 - Vandalia, Ohio, United States
- Pa0019 115 - Duncansville, Pennsylvania, United States
- Pa0019 142 - Rock Hill, South Carolina, United States
- Pa0019 116 - Jackson, Tennessee, United States
- Pa0019 138 - Murfreesboro, Tennessee, United States
- Pa0019 129 - Baytown, Texas, United States
- Pa0019 136 - Colleyville, Texas, United States
- Pa0019 135 - Mesquite, Texas, United States
- Pa0019 124 - Plano, Texas, United States
- Pa0019 121 - Bellevue, Washington, United States
- Pa0019 145 - Spokane, Washington, United States
- Pa0019 130 - Beckley, West Virginia, United States
- Pa0019 305 - Berlin, Germany
- Pa0019 407 - Bialystok, Poland
- Pa0019 418 - Bialystok, Poland
- Pa0019 705 - Brno, Czechia
- Pa0019 404 - Bytom, Poland
- Pa0019 401 - Elblag, Poland
- Pa0019 301 - Hamburg, Germany
- Pa0019 703 - Hlučín, Czechia
- Pa0019 601 - Košice, Slovakia
- Pa0019 412 - Krakow, Poland
- Pa0019 402 - Lodz, Poland
- Pa0019 204 - Lovech, Bulgaria
- Pa0019 410 - Lublin, Poland
- Pa0019 413 - Nowa Sól, Poland
- Pa0019 417 - Olsztyn, Poland
- Pa0019 704 - Ostrava, Czechia
- Pa0019 603 - Piešťany, Slovakia
- Pa0019 205 - Pleven, Bulgaria
- Pa0019 201 - Plovdiv, Bulgaria
- Pa0019 202 - Plovdiv, Bulgaria
- Pa0019 203 - Plovdiv, Bulgaria
- Pa0019 406 - Poznan, Poland
- Pa0019 408 - Poznan, Poland
- Pa0019 411 - Poznan, Poland
- Pa0019 415 - Płońsk, Poland
- Pa0019 302 - Ratingen, Germany
- Pa0019 416 - Torun, Poland
- Pa0019 702 - Uherské Hradiště, Czechia
- Pa0019 405 - Warsaw, Poland
- Pa0019 409 - Warsaw, Poland
Showing 60 of 63 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →