assignment
Recruiting

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

Trial statistics

location_city
38
research sites
public
6
countries
medical_information
2
diseases
person_search
42
investigators

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

Please provide the source data containing the specific details of the medications, dosages, and administration protocols. Once the data is provided, a description will be generated following all your specified structural and stylistic constraints.

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 BulgariaRecruiting02 Mar 202633
Croatia CroatiaNot Yet Recruiting02 Mar 202612
Czechia CzechiaRecruiting02 Mar 202617
Germany GermanyRecruiting02 Mar 202618
Poland PolandRecruiting02 Mar 2026203
Slovakia SlovakiaNot Yet Recruiting02 Mar 202610

Sites & Investigators

Conditions Studied in This Trial