A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Purpose
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Conditions
- Psoriatic Arthritis
- Axial Spondyloarthritis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Bimekizumab arm 1 |
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 or 2 during the PK Lead-In Phase and dosing regimen 1 or 2 during Treatment Period. |
|
|
Experimental Bimekizumab arm 2 |
Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the PK Lead-In Phase and dosing regimen 3 during Treatment Period. |
|
Recruiting Locations
Pa0019 114
Peoria, Arizona 85381-5025
Peoria, Arizona 85381-5025
Pa0019 127
Apple Valley, California 92307
Apple Valley, California 92307
Pa0019 111
Covina, California 91722
Covina, California 91722
Pa0019 117
Riverside, California 92518
Riverside, California 92518
Pa0019 125
San Leandro, California 94578
San Leandro, California 94578
Pa0019 126
Temecula, California 92592
Temecula, California 92592
Pa0019 141
Upland, California 91786
Upland, California 91786
Pa0019 120
Whittier, California 90602
Whittier, California 90602
Pa0019 128
Whittier, California 90602
Whittier, California 90602
Pa0019 123
Fort Collins, Colorado 80528
Fort Collins, Colorado 80528
Pa0019 143
Ormond Beach, Florida 32174
Ormond Beach, Florida 32174
Pa0019 113
South Miami, Florida 33155
South Miami, Florida 33155
Pa0019 132
Chicago, Illinois 60661
Chicago, Illinois 60661
Pa0019 134
Lansing, Michigan 48911
Lansing, Michigan 48911
Pa0019 140
West Long Branch, New Jersey 07764-1503
West Long Branch, New Jersey 07764-1503
Pa0019 131
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87102
Pa0019 144
Vandalia, Ohio 45377
Vandalia, Ohio 45377
Pa0019 115
Duncansville, Pennsylvania 16635
Duncansville, Pennsylvania 16635
Pa0019 142
Rock Hill, South Carolina 29732
Rock Hill, South Carolina 29732
Pa0019 116
Jackson, Tennessee 38305
Jackson, Tennessee 38305
Pa0019 138
Murfreesboro, Tennessee 37128
Murfreesboro, Tennessee 37128
Pa0019 129
Baytown, Texas 77521
Baytown, Texas 77521
Pa0019 136
Colleyville, Texas 76034
Colleyville, Texas 76034
Pa0019 135
Mesquite, Texas 75150
Mesquite, Texas 75150
Pa0019 124
Plano, Texas 75075
Plano, Texas 75075
Pa0019 121
Bellevue, Washington 98004
Bellevue, Washington 98004
Pa0019 145
Spokane, Washington 99216
Spokane, Washington 99216
Pa0019 130
Beckley, West Virginia 25801
Beckley, West Virginia 25801
More Details
- Status
- Recruiting
- Sponsor
- UCB Biopharma SRL