A Study to Evaluate the Efficacy, Safety, and Drug Concentration of Certolizumab Pegol (CZP) in Children and Adolescent Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO) (CIMcare)
A Study to Evaluate the Efficacy, Safety, and Drug Concentration of Certolizumab Pegol (CZP) in Children and Adolescent Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO) (CIMcare)
ClinicalTrials.gov ID: NCT04123795
Sponsor: UCB Biopharma SRL
Information provided by: UCB Pharma (UCB Biopharma SRL) (Responsible Party)
Last Update Posted: 2024-02-16
Brief Summary:
The purpose of the study is to demonstrate the efficacy and safety of certolizumab pegol in the treatment of moderate to severe chronic plaque psoriasis in study participants aged 6 to 11 and 12 to 17 years.
Official Title:
Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled (12-17 Years) Including a Single Open-Label Arm (6-11 Years) Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol (CZP) in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)
Intervention / Treatment:
- Drug: Certolizumab pegol
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2020-01-21 |
| Primary Completion (Estimated) | 2029-09-18 |
| Study Completion (Estimated) | 2034-08-14 |
| Enrollment (Estimated) | 150 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
PS0007
|