A Multicenter, Randomized, Parallel-Group, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
UCB Biopharma SRL
Summary
The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to \<18 years of age with moderate to severe plaque psoriasis (PSO).
Eligibility
- Age range
- 6–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Study participant must be 6 to \<18 years of age, inclusive, at the time of signing the informed consent/assent according to local regulation * Study participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit * Study participant meets the following at both the Screening and Baseline Visits: 1. Body surface area (BSA) affected by PSO ≥10% 2. . Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4) 3. . Psoriasis Area and Severity Index (PASI) score ≥12 OR PASI score ≥10 plus at…
Interventions
- Drugbimekizumab
Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study.
- Drugustekinumab
Study participants receive ustekinumab (USTE) administered as subcutaneous injection at pre-specified timepoints during the study.
- Drugplacebo
Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding.
Locations (50)
- Ps0021 50162Fountain Valley, California
- Ps0021 50161Los Angeles, California
- Ps0021 50196Northridge, California
- Ps0021 50581Miami, Florida
- Ps0021 50344Indianapolis, Indiana
- Ps0021 50599Kew Gardens, New York