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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - Study participant must be 6 to \<18 years of age, inclusive, at the time of signing the willing to sign a consent form/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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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 (20)

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