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

May 21, 2026 updated by: UCB Biopharma SRL

An Open-label, Randomized, Parallel-group, Noninferiority Study to Evaluate the Pharmacokinetics of Bimekizumab Administered Intravenously or as a Subcutaneous Injection in Participants With Active Psoriatic Arthritis and/or Active Axial Spondyloarthritis

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

392

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: UCB Cares
  • Phone Number: +18445992273

Study Locations

  • Bulgaria
      • Lovech, Bulgaria
        • Recruiting
        • Pa0019 204
      • Pleven, Bulgaria
        • Recruiting
        • Pa0019 205
      • Plovdiv, Bulgaria
        • Recruiting
        • Pa0019 201
      • Plovdiv, Bulgaria
        • Recruiting
        • Pa0019 202
      • Plovdiv, Bulgaria
        • Recruiting
        • Pa0019 203
  • Czechia
      • Brno, Czechia
        • Recruiting
        • Pa0019 705
      • Ostrava, Czechia
        • Recruiting
        • Pa0019 704
      • Uherské Hradiště, Czechia
        • Recruiting
        • Pa0019 702
  • Germany
      • Berlin, Germany
        • Recruiting
        • Pa0019 305
      • Hamburg, Germany
        • Recruiting
        • Pa0019 301
      • Ratingen, Germany
        • Recruiting
        • Pa0019 302
      • Wetzlar, Germany
        • Recruiting
        • Pa0019 306
  • Poland
      • Bialystok, Poland
        • Recruiting
        • Pa0019 407
      • Bialystok, Poland
        • Recruiting
        • Pa0019 418
      • Bytom, Poland
        • Recruiting
        • Pa0019 404
      • Elblag, Poland
        • Recruiting
        • Pa0019 401
      • Krakow, Poland
        • Recruiting
        • Pa0019 412
      • Lodz, Poland
        • Recruiting
        • Pa0019 402
      • Lublin, Poland
        • Recruiting
        • Pa0019 410
      • Nowa Sól, Poland
        • Recruiting
        • Pa0019 413
      • Olsztyn, Poland
        • Recruiting
        • Pa0019 417
      • Poznan, Poland
        • Recruiting
        • Pa0019 406
      • Poznan, Poland
        • Recruiting
        • Pa0019 408
      • Poznan, Poland
        • Recruiting
        • Pa0019 411
      • Płońsk, Poland
        • Recruiting
        • Pa0019 415
      • Warsaw, Poland
        • Recruiting
        • Pa0019 414
      • Warsaw, Poland
        • Recruiting
        • Pa0019 405
      • Wroclaw, Poland
        • Recruiting
        • Pa0019 420
  • Slovakia
      • Košice, Slovakia
        • Recruiting
        • Pa0019 601
  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381-5025
        • Recruiting
        • Pa0019 114
    • California
      • Apple Valley, California, United States, 92307
        • Recruiting
        • Pa0019 127
      • Covina, California, United States, 91722
        • Recruiting
        • Pa0019 111
      • Riverside, California, United States, 92518
        • Recruiting
        • Pa0019 117
      • San Leandro, California, United States, 94578
        • Recruiting
        • Pa0019 125
      • Temecula, California, United States, 92592
        • Recruiting
        • Pa0019 126
      • Upland, California, United States, 91786
        • Recruiting
        • Pa0019 141
      • Whittier, California, United States, 90602
        • Recruiting
        • Pa0019 128
      • Whittier, California, United States, 90602
        • Recruiting
        • Pa0019 120
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • Pa0019 123
    • Florida
      • Ormond Beach, Florida, United States, 32174
        • Recruiting
        • Pa0019 143
      • South Miami, Florida, United States, 33155
        • Recruiting
        • Pa0019 113
    • Illinois
      • Chicago, Illinois, United States, 60661
        • Recruiting
        • Pa0019 132
    • Michigan
      • Lansing, Michigan, United States, 48911
        • Recruiting
        • Pa0019 134
    • New Jersey
      • West Long Branch, New Jersey, United States, 07764-1503
        • Recruiting
        • Pa0019 140
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • Pa0019 131
    • Ohio
      • Vandalia, Ohio, United States, 45377
        • Recruiting
        • Pa0019 144
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Recruiting
        • Pa0019 115
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Pa0019 142
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Recruiting
        • Pa0019 116
      • Murfreesboro, Tennessee, United States, 37128
        • Recruiting
        • Pa0019 138
    • Texas
      • Baytown, Texas, United States, 77521
        • Recruiting
        • Pa0019 129
      • Colleyville, Texas, United States, 76034
        • Recruiting
        • Pa0019 136
      • Mesquite, Texas, United States, 75150
        • Recruiting
        • Pa0019 135
      • Plano, Texas, United States, 75075
        • Recruiting
        • Pa0019 124
    • Washington
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • Pa0019 121
      • Spokane, Washington, United States, 99216
        • Recruiting
        • Pa0019 145
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Recruiting
        • Pa0019 130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Steady-state Trough Concentration (Ctrough,ss) at Week 16
Time Frame: Week 16
Steady-state trough concentration (Ctrough,ss) will be reported.
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of treatment-emergent Adverse Events (TEAEs) from Baseline to the end of Safety Follow-Up (SFU) Visit
Time Frame: From Baseline to the end of SFU Visit (up to Week 29)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention and on or before 17 weeks after the final administration of study intervention. This includes AEs that worsen in intensity after the start of study intervention.
From Baseline to the end of SFU Visit (up to Week 29)
Occurrence of treatment-emergent Serious Adverse Events (SAEs) from Baseline to the end of SFU Visit
Time Frame: From Baseline to the end of SFU Visit (up to Week 29)
An SAE is any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; Other situations: Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention and on or before 17 weeks after the final administration of study intervention. This includes AEs that worsen in intensity after the start of study intervention.
From Baseline to the end of SFU Visit (up to Week 29)
Occurrence of TEAEs leading to withdrawal of study intervention
Time Frame: From Baseline to the end of SFU Visit (up to Week 29)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention and on or before 17 weeks after the final administration of study intervention. This includes AEs that worsen in intensity after the start of study intervention. TEAEs leading to withdrawal of IMP of the study will be reported.
From Baseline to the end of SFU Visit (up to Week 29)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Biopharma SRL

Investigators

  • Study Director: UCB Cares, 001 844 599 22733 (UCB)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2025

Primary Completion (Estimated)

May 18, 2028

Study Completion (Estimated)

September 14, 2028

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA0019
  • 2025-522782-30 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The sponsor does not plan to share IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriatic Arthritis

Clinical Trials on Bimekizumab regimen 1 iv

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe