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

Description

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).

Conditions

Moderate to Severe Plaque Psoriasis

Study Overview

Study Details

Study 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).

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

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

Condition
Moderate to Severe Plaque Psoriasis
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Ps0021 50161, Los Angeles, California, United States, 90045

Northridge

Ps0021 50196, Northridge, California, United States, 91325

Indianapolis

Ps0021 50344, Indianapolis, Indiana, United States, 46250

Kew Gardens

Ps0021 50599, Kew Gardens, New York, United States, 11415

Arlington

Ps0021 50201, Arlington, Texas, United States, 76011

Dallas

Ps0021 50355, Dallas, Texas, United States, 75235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

UCB Biopharma SRL,

UCB Cares, STUDY_DIRECTOR, 001 844 599 2273

Study Record Dates

2030-11-08