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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-17
SponsorUCB Biopharma SRL

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

Treatment groups

168 Participants
are divided into 2 treatment groups

Sponsors and collaborators