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).
Eligibility criteria
Qualifiers
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
Body surface area (BSA) affected by PSO ≥10%
. Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
Disqualifiers
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
Trial design
Treatments tested in this trial
- bimekizumab
- ustekinumab
- placebo