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Taking people in BulgariaPhase 1

Bimekizumab given by vein or by injection in psoriatic arthritis and axial spondyloarthritis

Compares bimekizumab given by vein or injection in adults with active joint disease.

Key facts

Who runs it
UCB Biopharma SRL
Where
Lovech, Pleven, and Plovdiv, BulgariaSee the 5 sitesAlso in 5 other countries, 60 sites
Registry title
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Status
Recruiting
Phase
Phase 1
People taking part
392 people, planned
Started
10 Dec 2025
Expected to end
14 Sept 2028
Type of study
Interventional, 2 groups
Treatments tested
  • Bimekizumab regimen 1 iv
  • Bimekizumab regimen 2 iv
  • Bimekizumab regimen 3 sc
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with active psoriatic arthritis or active axial spondyloarthritis who can have bimekizumab treatment. It compares bimekizumab given into a vein with bimekizumab given as an injection under the skin.

Age
18 years or older, and able to give legal consent.
Sex
All sexes can join.
Disease stage
Active psoriatic arthritis (PsA) or active axial spondyloarthritis (axSpA).
Earlier treatment
People must have had no biologic disease-modifying anti-rheumatic drug (bDMARD) before, or must have stopped it at least 3 months or 5 half-lives ago.

Main reasons for not taking part

  • Serious organ disorders (for example heart, liver, kidney, gut or nervous system)
  • Severe psychiatric problems or substance abuse in the past year
  • Recent or long-lasting infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB)
  • Other inflammatory diseases (for example rheumatoid arthritis, lupus, inflammatory bowel disease)
  • Recent live vaccine (within 8 weeks), BCG vaccine (within 1 year) or GLP-1 agonist use (within 28 weeks)

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year)
  • 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 use of glucagon-like peptide-1 (GLP-1) agonists (within 28 weeks)

Where in Bulgaria

Also in 5 other countries, 60 sites

  • Pa0019 204Lovech, BulgariaContact: UCB CaresTaking people
  • Pa0019 205Pleven, BulgariaContact: UCB CaresTaking people
  • Pa0019 201Plovdiv, BulgariaContact: UCB CaresTaking people
  • Pa0019 202Plovdiv, BulgariaContact: UCB CaresTaking people
  • Pa0019 203Plovdiv, BulgariaContact: UCB CaresTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Bimekizumab arm 1Treatment being tested

    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.

    Treatment: Bimekizumab regimen 1 iv and Bimekizumab regimen 2 iv

  • Bimekizumab arm 2Treatment being tested

    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.

    Treatment: Bimekizumab regimen 3 sc

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Bimekizumab given by vein or by injection in psoriatic arthritis and axial spondyloarthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 November 2026