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Recruiting NCT07290036

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

Phase I Interventional Psoriatic Arthritis Axial Spondyloarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bimekizumab regimen 1 iv, Bimekizumab regimen 2 iv, Bimekizumab regimen 3 sc.
Who it may be relevant to
Registry conditions: Psoriatic Arthritis, Axial Spondyloarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Bulgaria, Czechia, Germany, Poland +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • 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.
  • Drug Bimekizumab regimen 3 sc
    Participants will receive bimekizumab (BKZ) at pre-specified time points.

Primary outcome measures

  • Steady-state Trough Concentration (Ctrough,ss) at Week 16 [Time frame: Week 16]
Secondary outcome measures (3)
  • 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)]
  • 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)]
  • Occurrence of TEAEs leading to withdrawal of study intervention [Time frame: From Baseline to the end of SFU Visit (up to Week 29)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 30 centers
  • Pa0019 114 — Peoria
  • Pa0019 127 — Apple Valley
  • Pa0019 111 — Covina
  • Pa0019 119 — Fullerton
  • Pa0019 117 — Riverside
  • Pa0019 125 — San Leandro
  • Pa0019 126 — Temecula
  • Pa0019 141 — Upland
  • … and 22 more centers
Poland · 18 centers
  • Pa0019 407 — Bialystok
  • Pa0019 418 — Bialystok
  • Pa0019 404 — Bytom
  • Pa0019 401 — Elblag
  • Pa0019 412 — Krakow
  • Pa0019 402 — Lodz
  • Pa0019 410 — Lublin
  • Pa0019 413 — Nowa Sól
  • … and 10 more centers
Bulgaria · 5 centers
  • Pa0019 204 — Lovech
  • Pa0019 205 — Pleven
  • Pa0019 201 — Plovdiv
  • Pa0019 202 — Plovdiv
  • Pa0019 203 — Plovdiv
Czechia · 4 centers
  • Pa0019 705 — Brno
  • Pa0019 703 — Hlučín
  • Pa0019 704 — Ostrava
  • Pa0019 702 — Uherské Hradiště
Germany · 4 centers
  • Pa0019 305 — Berlin
  • Pa0019 301 — Hamburg
  • Pa0019 302 — Ratingen
  • Pa0019 306 — Wetzlar
Slovakia · 2 centers
  • Pa0019 601 — Košice
  • Pa0019 603 — Piešťany

Identifiers

NCT: NCT07290036 · PA0019 · 2025-522782-30

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗