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

NCT ID: NCT07290036

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2028-07-04

Brief Summary

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

Detailed Description

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Conditions

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Psoriatic Arthritis Axial Spondyloarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Bimekizumab regimen 1 iv

Intervention Type DRUG

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

Bimekizumab regimen 2 iv

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Bimekizumab regimen 3 sc

Intervention Type DRUG

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

Interventions

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Bimekizumab regimen 1 iv

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

Intervention Type DRUG

Bimekizumab regimen 2 iv

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

Intervention Type DRUG

Bimekizumab regimen 3 sc

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Biopharma SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

001 844 599 22733 (UCB)

Locations

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Pa0019 114

Peoria, Arizona, United States

Site Status RECRUITING

Pa0019 127

Apple Valley, California, United States

Site Status RECRUITING

Pa0019 111

Covina, California, United States

Site Status RECRUITING

Pa0019 120

Whittier, California, United States

Site Status RECRUITING

Pa0019 128

Whittier, California, United States

Site Status RECRUITING

Pa0019 113

South Miami, Florida, United States

Site Status RECRUITING

Pa0019 115

Duncansville, Pennsylvania, United States

Site Status RECRUITING

Pa0019 116

Jackson, Tennessee, United States

Site Status RECRUITING

Pa0019 121

Bellevue, Washington, United States

Site Status RECRUITING

Pa0019 130

Beckley, West Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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UCB Cares

Role: CONTACT

+18445992273

UCB Cares

Role: CONTACT

+18445992273

Other Identifiers

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2025-522782-30

Identifier Type: OTHER

Identifier Source: secondary_id

PA0019

Identifier Type: -

Identifier Source: org_study_id

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