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RECRUITINGPhase 1INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DRUG

Bimekizumab regimen 1 iv

Participants will receive bimekizumab (BKZ) at pre-specified time points.

DRUG

Bimekizumab regimen 2 iv

Participants will receive bimekizumab (BKZ) at pre-specified time points.

DRUG

Bimekizumab regimen 3 sc

Participants will receive bimekizumab (BKZ) at pre-specified time points.

Locations (20)

Pa0019 114
Peoria, Arizona, United States
Pa0019 127
Apple Valley, California, United States
Pa0019 111
Covina, California, United States
Pa0019 117
Riverside, California, United States
Pa0019 125
San Leandro, California, United States
Pa0019 126
Temecula, California, United States
Pa0019 120
Whittier, California, United States
Pa0019 128
Whittier, California, United States
Pa0019 123
Fort Collins, Colorado, United States
Pa0019 113
South Miami, Florida, 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 115
Duncansville, Pennsylvania, United States
Pa0019 116
Jackson, Tennessee, 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 130
Beckley, West Virginia, United States