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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
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
Conditions
Interventions
bimekizumab
Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study.
ustekinumab
Study participants receive ustekinumab (USTE) administered as subcutaneous injection at pre-specified timepoints during the study.
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