NCT06425549

A 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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Moderate to Severe Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	bimekizumab	Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study.
DRUG	ustekinumab	Study participants receive ustekinumab (USTE) administered as subcutaneous injection at pre-specified timepoints during the study.
DRUG	placebo	Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding.

Timeline

• Start date: 2024-06-25
• Primary completion: 2028-08-21
• Completion: 2030-11-08
• First posted: 2024-05-22
• Last updated: 2026-04-13

Locations

50 sites across 11 countries: United States, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Poland, Spain

Regulatory

• FDA-regulated drug study