Trials Today

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.	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 5308480, Arizona 5551752 85381-5025

Pa0019 127
Apple Valley 5324363, California 5332921 92307

Pa0019 111
Covina 5340175, California 5332921 91722

Pa0019 120
Whittier 5409059, California 5332921 90602

Pa0019 128
Whittier 5409059, California 5332921 90602

Pa0019 113
South Miami 4173495, Florida 4155751 33155

Pa0019 115
Duncansville 5187508, Pennsylvania 6254927 16635

Pa0019 116
Jackson 4632595, Tennessee 4662168 38305

Pa0019 121
Bellevue 5786882, Washington 5815135 98004

Pa0019 130
Beckley 4798308, West Virginia 4826850 25801

More Details

NCT ID: NCT07290036
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.