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NCT06425549PHASE3Recruiting

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

UCB Biopharma SRL

Start Date

6/25/2024

Completion Date

11/8/2030

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 Criteria

Age Range: 6 years to 17 years

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 least 1 of the following: i) Clinically relevant facial involvement ii) Clinically relevant genital involvement iii) Clinically relevant hand and foot involvement * Study participant is a candidate for systemic PSO therapy and/or photo/chemotherapy and for treatment with ustekinumab per labeling * Study participant has body weight ≥15 kg and body mass index for age percentile of ≥5 at Screening Exclusion Criteria: * Primary failure (no response within 12 weeks) to 1 or more interleukin-17 (IL-17) biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17 * Study participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO * Study participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD * History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated * Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections) * Study participant has previously received bimekizumab * Study participant has previously received ustekinumab * Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments * Study participant has the presence of active suicidal ideation, or positive suicide behavior * Study participant diagnosed with severe depression in the past 6 months (prior to Screening) should be excluded * Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study

Interventions

DRUG

bimekizumab

DRUG

ustekinumab

DRUG

placebo

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Conditions

Moderate to Severe Plaque Psoriasis

Locations

Ps0021 50162

Fountain Valley, California 92708

United States

Ps0021 50161

Los Angeles, California 90045

United States

Ps0021 50196

Northridge, California 91325

United States

Ps0021 50581

Miami, Florida 33165

United States

Ps0021 50344

Indianapolis, Indiana 46250

United States

Ps0021 50599

Kew Gardens, New York 11415

United States

Ps0021 50084

Charleston, South Carolina 29425

United States

Ps0021 50201

Arlington, Texas 76011

United States

Ps0021 50355

Dallas, Texas 75235

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 40625

Lodz,

Poland

Ps0021 40832

Lodz,

Poland

Ps0021 40091

Nowa Sól,

Poland

Ps0021 40737

Rzeszów,

Poland

Ps0021 40743

Szczecin,

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