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NCT Number: NCT07290036

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

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

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Key information

Conditions

Psoriatic Arthritis Ankylosis Arthritis Arthritis, Psoriatic Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pa0019 204, Lovech, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be 18+ years old and legally able to consent
  • Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment
  • Weigh between 45-100 kg (females) or 50-100 kg (males).
  • Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago

Exclusion criteria

  • Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro)
  • Severe psychiatric issues or substance abuse in the past year
  • Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB)
  • Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD))
  • Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year)
  • Recent use of glucagon-like peptide-1 (GLP-1) agonists (within 28 weeks)

Treatment and study plan

Bimekizumab regimen 1 iv

Drug

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

Bimekizumab regimen 2 iv

Drug

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

Bimekizumab regimen 3 sc

Drug

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

Primary outcomes

  1. Steady-state Trough Concentration (Ctrough,ss) at Week 16

    Time frame: Week 16

    Steady-state trough concentration (Ctrough,ss) will be reported.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

UCB Cares

CONTACT

[email protected]

+18445992273

UCB Cares

CONTACT

+18445992273

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 17, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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