A Pharmacokinetic and Safety Study of Bimekizumab via Different Routes of Administration in Adults with Chronic Cutaneous Inflammation
- Trial ID
- 2025-522782-30-00
- Protocol
- PA0019
- Sponsor
- UCB Biopharma
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the safety and pharmacokinetics of bimekizumab administered via different routes in adults with concanavalin A-induced colitis. Assessing these parameters is clinically significant to determine the tolerability and systemic exposure profiles of the therapeutic agent across varying administration methods. Secondary objectives involve the assessment of pharmacodynamics to characterize the biological effects of the treatment.
Participants
This clinical trial involves a total of 99 patients. The study population includes both male and female participants. Individuals identified in the study belong to the vulnerable population category. All subjects are diagnosed with chronic compartment syndrome. The age range of the participants corresponds to specific pediatric or adolescent age classifications.
Plans and Procedures
This Phase 3 clinical trial is designed to evaluate the safety and pharmacokinetics of bimekizumab when administered via different routes in adults with congenital cataract ichthyosis. The study design utilizes a comparative approach to assess how the drug moves through the body over time. The research process begins with a screening visit to determine eligibility. Following enrollment, participants will attend scheduled follow-up visits to monitor safety and biological responses. The sequence concludes with an end-of-study visit. The total duration of participation is determined by the specific study protocols and scheduled assessments. Early termination from the study may occur based on predefined clinical criteria or safety considerations.
Treatment
Efficacy
The assessment of efficacy in this Phase 3 clinical trial for cervical artery dissection involves specific clinical parameters. Information regarding the precise endpoints, measurement schedules, or diagnostic instruments utilized to evaluate treatment response is not provided.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Bulgaria | Recruiting | 02 Mar 2026 | 33 |
Croatia | Not Yet Recruiting | 02 Mar 2026 | 12 |
Czechia | Recruiting | 02 Mar 2026 | 17 |
Germany | Recruiting | 02 Mar 2026 | 18 |
Poland | Recruiting | 02 Mar 2026 | 203 |
Slovakia | Not Yet Recruiting | 02 Mar 2026 | 10 |






