Recruiting

Phase 1

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

Sponsor:

UCB Biopharma SRL

Code:

NCT07290036

Conditions

Psoriatic Arthritis

Axial Spondyloarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bimekizumab regimen 1 iv

Bimekizumab regimen 2 iv

Bimekizumab regimen 3 sc

Study Details

Brief summary:

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

Conditions

Psoriatic Arthritis

Axial Spondyloarthritis

Study ID

NCT07290036

Start date

Dec 10, 2025

Status verified date

Jul, 2026

Completion date

Sep 14, 2028

Anticipated

Primary completion date

May 18, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

392 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Bimekizumab regimen 1 iv

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

Bimekizumab regimen 2 iv

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

Bimekizumab regimen 3 sc

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

Primary outcome measure

Steady-state Trough Concentration (Ctrough,ss) at Week 16 [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

UCB Cares

+18445992273 ucbcares@ucb.com

UCB Cares

+18445992273

Locations

Pa0019 114

Recruiting

Peoria, Arizona, United States, 85381-5025

Pa0019 127

Recruiting

Apple Valley, California, United States, 92307

Pa0019 111

Recruiting

Covina, California, United States, 91722

Pa0019 119

Recruiting

Fullerton, California, United States, 92835

Pa0019 117

Recruiting

Riverside, California, United States, 92518

Pa0019 125

Recruiting

San Leandro, California, United States, 94578

Pa0019 126

Recruiting

Temecula, California, United States, 92592

Pa0019 141

Recruiting

Upland, California, United States, 91786

Pa0019 120

Recruiting

Whittier, California, United States, 90602

Pa0019 128

Recruiting

Whittier, California, United States, 90602

Pa0019 123

Recruiting

Fort Collins, Colorado, United States, 80528

Pa0019 143

Recruiting

Ormond Beach, Florida, United States, 32174

Pa0019 113

Recruiting

South Miami, Florida, United States, 33155

Pa0019 133

Recruiting

Zephyrhills, Florida, United States, 33542

Pa0019 132

Recruiting

Chicago, Illinois, United States, 60661

Pa0019 134

Recruiting

Lansing, Michigan, United States, 48911

Pa0019 140

Recruiting

West Long Branch, New Jersey, United States, 07764-1503

Pa0019 131

Recruiting

Albuquerque, New Mexico, United States, 87102

Pa0019 144

Recruiting

Vandalia, Ohio, United States, 45377

Pa0019 115

Recruiting

Duncansville, Pennsylvania, United States, 16635

Pa0019 142

Recruiting

Rock Hill, South Carolina, United States, 29732

Pa0019 116

Recruiting

Jackson, Tennessee, United States, 38305

Pa0019 138

Recruiting

Murfreesboro, Tennessee, United States, 37128

Pa0019 129

Recruiting

Baytown, Texas, United States, 77521

Pa0019 136

Recruiting

Colleyville, Texas, United States, 76034

Pa0019 135

Recruiting

Mesquite, Texas, United States, 75150

Pa0019 124

Recruiting

Plano, Texas, United States, 75075

Pa0019 121

Recruiting

Bellevue, Washington, United States, 98004

Pa0019 145

Recruiting

Spokane, Washington, United States, 99216

Pa0019 130

Recruiting

Beckley, West Virginia, United States, 25801

More Information

Sponsor

UCB Biopharma SRL

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

Bimekizumab, BKZ, Phase 1B

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by UCB Biopharma SRL on 2026-07-06.