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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned 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.
  • 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.
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.
  • Drug: Bimekizumab regimen 3 sc
    Participants will receive bimekizumab (BKZ) at pre-specified time points.

Recruiting Locations

Pa0019 114
Peoria, Arizona 85381-5025

Pa0019 127
Apple Valley, California 92307

Pa0019 111
Covina, California 91722

Pa0019 117
Riverside, California 92518

Pa0019 125
San Leandro, California 94578

Pa0019 126
Temecula, California 92592

Pa0019 141
Upland, California 91786

Pa0019 120
Whittier, California 90602

Pa0019 128
Whittier, California 90602

Pa0019 123
Fort Collins, Colorado 80528

Pa0019 143
Ormond Beach, Florida 32174

Pa0019 113
South Miami, Florida 33155

Pa0019 132
Chicago, Illinois 60661

Pa0019 134
Lansing, Michigan 48911

Pa0019 140
West Long Branch, New Jersey 07764-1503

Pa0019 131
Albuquerque, New Mexico 87102

Pa0019 144
Vandalia, Ohio 45377

Pa0019 115
Duncansville, Pennsylvania 16635

Pa0019 142
Rock Hill, South Carolina 29732

Pa0019 116
Jackson, Tennessee 38305

Pa0019 138
Murfreesboro, Tennessee 37128

Pa0019 129
Baytown, Texas 77521

Pa0019 136
Colleyville, Texas 76034

Pa0019 135
Mesquite, Texas 75150

Pa0019 124
Plano, Texas 75075

Pa0019 121
Bellevue, Washington 98004

Pa0019 145
Spokane, Washington 99216

Pa0019 130
Beckley, West Virginia 25801

More Details

Status
Recruiting
Sponsor
UCB Biopharma SRL

Study Contact

UCB Cares
+18445992273
ucbcares@ucb.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.