PS0021 Enrolling

Plaque Psoriasis Clinical Trial for Children and Adolescents


Treatment: Injection Age: 6-17 Years


Clinical trial testing an investigational drug for moderate to severe plaque psoriasis in children and adolescents.

 

To qualify for the study, individuals must meet the following inclusion criteria:

      • be 6 to less than 18 years of age
      • have a diagnosis of moderate to severe plaque psoriasis for at least 3 months prior to the Screening Visit
      • have body surface area (BSA)* affected by psoriasis ≥10%
      • have no other medical condition (including other dermatological conditions) that would preclude participation/assessment in the study

* 1% of your body surface area is roughly equal to the palm of your hand (no wrists or fingers)

 

Participants will receive an investigational drug (active study drug) or comparator drug, via injection.  Study medication and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses may be provided.

 

Study participation will last about 169 weeks and involve about 26 visits to the study research centre.


Participating Locations

COUNTRY
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Canada

Participating Experts

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The following information is from ClinicalTrials.gov

Last Update Posted: October 16, 2024

Official Title

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

ClinicalTrials.gov ID

NCT06425549

Sponsor

UCB Biopharma SRL

Study Description

  • Brief Summary:

    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).

  • Condition or Disease:

    Moderate to Severe Plaque Psoriasis

  • Intervention/Treatment:

    Drug: bimekizumab,Drug: placebo Drug: bimekizumab,Drug: ustekinumab,Drug: placebo
  • Phase:

    PHASE 3

  • Ages Eligible for Study:

    6 Years and 17 Years (CHILD)

  • Sexes Eligible for Study:

    ALL


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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