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Clinical Trials in the USA / NCT07290036
Recruiting Phase 1

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

NCT07290036 · tracked via the Priya Life Science USA tracker
Sponsor
UCB Biopharma SRL
Phase
Phase 1
Started
2025-12-10
Last updated
2026-07-06

Condition(s) studied

Psoriatic ArthritisAxial Spondyloarthritis

Investigational drug(s) / intervention(s)

Bimekizumab regimen 1 ivBimekizumab regimen 2 ivBimekizumab regimen 3 sc

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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)

Primary outcome measure(s)

  • Steady-state Trough Concentration (Ctrough,ss) at Week 16 — Week 16
    Steady-state trough concentration (Ctrough,ss) will be reported.

Trial sites (63)

FacilityCityRegionStatus
Pa0019 114 Peoria Arizona Recruiting
Pa0019 127 Apple Valley California Recruiting
Pa0019 111 Covina California Recruiting
Pa0019 119 Fullerton California Recruiting
Pa0019 117 Riverside California Recruiting
Pa0019 125 San Leandro California Recruiting
Pa0019 126 Temecula California Recruiting
Pa0019 141 Upland California Recruiting
Pa0019 120 Whittier California Recruiting
Pa0019 128 Whittier California Recruiting
Pa0019 123 Fort Collins Colorado Recruiting
Pa0019 143 Ormond Beach Florida Recruiting
Pa0019 113 South Miami Florida Recruiting
Pa0019 133 Zephyrhills Florida Recruiting
Pa0019 132 Chicago Illinois Recruiting
Pa0019 134 Lansing Michigan Recruiting
Pa0019 140 West Long Branch New Jersey Recruiting
Pa0019 131 Albuquerque New Mexico Recruiting
Pa0019 144 Vandalia Ohio Recruiting
Pa0019 115 Duncansville Pennsylvania Recruiting
Pa0019 142 Rock Hill South Carolina Recruiting
Pa0019 116 Jackson Tennessee Recruiting
Pa0019 138 Murfreesboro Tennessee Recruiting
Pa0019 129 Baytown Texas Recruiting
Pa0019 136 Colleyville Texas Recruiting
Pa0019 135 Mesquite Texas Recruiting
Pa0019 124 Plano Texas Recruiting
Pa0019 121 Bellevue Washington Recruiting
Pa0019 145 Spokane Washington Recruiting
Pa0019 130 Beckley West Virginia Recruiting
Pa0019 204 Lovech Bulgaria Recruiting
Pa0019 205 Pleven Bulgaria Recruiting
Pa0019 201 Plovdiv Bulgaria Recruiting
Pa0019 202 Plovdiv Bulgaria Recruiting
Pa0019 203 Plovdiv Bulgaria Recruiting
Pa0019 705 Brno Czechia Recruiting
Pa0019 703 Hlučín Czechia Recruiting
Pa0019 704 Ostrava Czechia Recruiting
Pa0019 702 Uherské Hradiště Czechia Recruiting
Pa0019 305 Berlin Germany Recruiting

+ 23 more sites — see the full list on the official registry below.

More UCB Biopharma SRL trials in the USA

A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis Active, not recruiting
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures Recruiting
A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab) Recruiting
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOGAD) Active, not recruiting
A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis Active, not recruiting

Other trials for the same condition

Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System Active, not recruiting
Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis Active, not recruiting
A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab) Recruiting
A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis Active, not recruiting
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07290036 on ClinicalTrials.gov ↗ ← All trials in the USA