NCT07290036 A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
| NCT ID | NCT07290036 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | UCB Biopharma SRL |
| Condition | Psoriatic Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 392 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2028-05-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 392 participants in total. It began in 2025-12-10 with a primary completion date of 2028-05-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Eligibility Criteria
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)
Contact & Investigator
UCB Cares
STUDY DIRECTOR
001 844 599 22733 (UCB)
Frequently Asked Questions
Who can join the NCT07290036 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psoriatic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07290036 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07290036 currently recruiting?
Yes, NCT07290036 is actively recruiting participants. Contact the research team at ucbcares@ucb.com for enrollment information.
Where is the NCT07290036 trial being conducted?
This trial is being conducted at Peoria, United States, Apple Valley, United States, Covina, United States, Fullerton, United States and 11 additional locations.
Who is sponsoring the NCT07290036 clinical trial?
NCT07290036 is sponsored by UCB Biopharma SRL. The principal investigator is UCB Cares at 001 844 599 22733 (UCB). The trial plans to enroll 392 participants.