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

NCT07290036
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Recruiting
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Participants
392
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Lead sponsor
UCB Biopharma SRL
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Start date
2025-12-10
clinicaltrials.gov
Number of sites
63
clinicaltrials.gov

Summary
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
clinicaltrials.gov
Short title
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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Official 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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-09-14
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First posted
2025-12-17
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Registry last updated
2026-07-06
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Primary completion date
2028-05-18
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Start date
2025-12-10
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Participants
392
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Participant count basis
Estimated
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Planned participants
392
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Protocol amendments
2
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Number of sites
63
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
UCB Biopharma SRL
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07290036
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ClinicalTrials.gov ID
NCT07290036
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

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

    Timeframe: Week 16

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

  1. Occurrence of treatment-emergent Adverse Events (TEAEs) from Baseline to the end of Safety Follow-Up (SFU) Visit

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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

  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)
Sources for eligibility
clinicaltrials.gov

  • Pa0019 114Peoria, United StatesRecruiting
  • Pa0019 127Apple Valley, United StatesRecruiting
  • Pa0019 111Covina, United StatesRecruiting
  • Pa0019 119Fullerton, United StatesRecruiting
  • Pa0019 117Riverside, United StatesRecruiting
  • Pa0019 125San Leandro, United StatesRecruiting
  • Pa0019 126Temecula, United StatesRecruiting
  • Pa0019 141Upland, United StatesRecruiting
  • Pa0019 120Whittier, United StatesRecruiting
  • Pa0019 128Whittier, United StatesRecruiting
  • Pa0019 123Fort Collins, United StatesRecruiting
  • Pa0019 143Ormond Beach, United StatesRecruiting
  • Pa0019 113South Miami, United StatesRecruiting
  • Pa0019 133Zephyrhills, United StatesRecruiting
  • Pa0019 132Chicago, United StatesRecruiting
  • Pa0019 134Lansing, United StatesRecruiting
  • Pa0019 140West Long Branch, United StatesRecruiting
  • Pa0019 131Albuquerque, United StatesRecruiting
  • Pa0019 144Vandalia, United StatesRecruiting
  • Pa0019 115Duncansville, United StatesRecruiting
  • Pa0019 142Rock Hill, United StatesRecruiting
  • Pa0019 116Jackson, United StatesRecruiting
  • Pa0019 138Murfreesboro, United StatesRecruiting
  • Pa0019 129Baytown, United StatesRecruiting
  • Pa0019 136Colleyville, United StatesRecruiting

And 38 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-522782-30
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (2)