Overview

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

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