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RECRUITING
NCT06425549
PHASE3

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

Sponsor: UCB Biopharma SRL

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2024-06-25

Completion Date

2030-11-08

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

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.

Locations (50)

Ps0021 50162

Fountain Valley, California, United States

Ps0021 50161

Los Angeles, California, United States

Ps0021 50196

Northridge, California, United States

Ps0021 50581

Miami, Florida, United States

Ps0021 50344

Indianapolis, Indiana, United States

Ps0021 50599

Kew Gardens, New York, United States

Ps0021 50084

Charleston, South Carolina, United States

Ps0021 50201

Arlington, Texas, United States

Ps0021 50355

Dallas, Texas, United States

Ps0021 40121

Brussels, Belgium

Ps0021 40420

Liège, Belgium

Ps0021 50618

Mississauga, Canada

Ps0021 50357

St. John's, Canada

Ps0021 50617

St. John's, Canada

Ps0021 40748

Plzen-bory, Czechia

Ps0021 40742

Argenteuil, France

Ps0021 40754

Nantes, France

Ps0021 40740

Bad Bentheim, Germany

Ps0021 40515

Berlin, Germany

Ps0021 40138

Bonn, Germany

Ps0021 40356

Dresden, Germany

Ps0021 40023

Erlangen, Germany

Ps0021 40645

Frankfurt am Main, Germany

Ps0021 40758

Hamburg, Germany

Ps0021 40249

Kiel, Germany

Ps0021 40747

Mainz, Germany

Ps0021 40177

Münster, Germany

Ps0021 40746

Debrecen, Hungary

Ps0021 40744

Kaposvár, Hungary

Ps0021 40745

Szeged, Hungary

Ps0021 40440

Ancona, Località Torrette, Italy

Ps0021 40749

Catania, Italy

Ps0021 40085

Pisa, Italy

Ps0021 40567

Roma, Italy

Ps0021 20071

Nagasaki, Japan

Ps0021 20033

Nagoya, Japan

Ps0021 20337

Shimotsuga-gun, Japan

Ps0021 40741

Bialystok, Poland

Ps0021 40832

Lodz, Poland

Ps0021 40091

Nowa Sól, Poland

Ps0021 40737

Rzeszów, Poland

Ps0021 40743

Szczecin, Poland

Ps0021 40625

Warsaw, Poland

Ps0021 40334

Wroclaw, Poland

Ps0021 40738

Wroclaw, Poland

Ps0021 40750

Alicante, Spain

Ps0021 40159

Barcelona, Spain

Ps0021 40751

Esplugues de Llobregat, Spain

Ps0021 40752

Granada, Spain

Ps0021 40753

Santiago de Compostela, Spain