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Recruiting Phase 1 NCT07290036

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

Phase 1 – testing safety in a small group of people
Conditions: Psoriatic Arthritis Axial Spondyloarthritis

Sponsor: UCB Biopharma SRL

trial.available_in: БГ
Overview
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Who can participate
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)
Interventions
Bimekizumab regimen 1 iv
DRUG
Bimekizumab regimen 2 iv
DRUG
Bimekizumab regimen 3 sc
DRUG
Locations 42
Bulgaria (4)
Pa0019 205
Pleven
Pa0019 201
Plovdiv
Pa0019 202
Plovdiv
Pa0019 203
Plovdiv
Germany (2)
Pa0019 301
Hamburg
Pa0019 302
Ratingen
Poland (12)
Pa0019 407
Bialystok
Pa0019 418
Bialystok
Pa0019 401
Elblag
Pa0019 412
Krakow
Pa0019 410
Lublin
Pa0019 417
Olsztyn
Pa0019 415
Płońsk
Pa0019 406
Poznan
Pa0019 408
Poznan
Pa0019 411
Poznan
Pa0019 414
Warsaw
Pa0019 420
Wroclaw
United States (24)
Pa0019 131
Albuquerque , New Mexico
Pa0019 127
Apple Valley , California
Pa0019 129
Baytown , Texas
Pa0019 130
Beckley , West Virginia
Pa0019 121
Bellevue , Washington
Pa0019 132
Chicago , Illinois
Pa0019 136
Colleyville , Texas
Pa0019 111
Covina , California
Pa0019 115
Duncansville , Pennsylvania
Pa0019 123
Fort Collins , Colorado
Pa0019 116
Jackson , Tennessee
Pa0019 134
Lansing , Michigan
Pa0019 135
Mesquite , Texas
Pa0019 114
Peoria , Arizona
Pa0019 124
Plano , Texas
Pa0019 117
Riverside , California
Pa0019 142
Rock Hill , South Carolina
Pa0019 125
San Leandro , California
Pa0019 113
South Miami , Florida
Pa0019 145
Spokane Valley , Washington
Pa0019 126
Temecula , California
Pa0019 140
West Long Branch , New Jersey
Pa0019 120
Whittier , California
Pa0019 128
Whittier , California
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
10.12.2025
Completion date
14.09.2028
Registry ID
NCT07290036
Source
clinicaltrials.gov
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