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

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)

Facility	City	Region	Status
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 Recruiting

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab) Recruiting

A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis Recruiting

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis 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

Other trials for the same condition

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 Active, not recruiting

A Study of SPY072 in Rheumatic Disease 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