PS0007 Enrolling

Youth Plaque Psoriasis Research Trial (3 Years)


Treatment: Injection Age: 12-17 Years


Youth aged 12 to 17 years old diagnosed with chronic plaque psoriasis for at least 6 months, may qualify to participate.  Individuals must have moderate to severe plaque psoriasis involving 10% or more body surface area (BSA), and a body weight of 20 kg or more.

Participants will receive investigational medication (active study drug) or placebo via subcutaneous injection.  From Week 16 onwards, all participants will receive active study drug for the duration of the trial.  Study medication and study-related care will be provided at no cost.  Reimbursement for study-related expenses will also be provided.

Study participation will last about 3 years and involve about 83 study visits (this includes 26 clinic visits, 7 home nurse visits, and 50 at-home visits for self-administration of study medication).


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The following information is from ClinicalTrials.gov

Last Update Posted: July 16, 2024

Official Title

Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled (12-17 Years) Including a Single Open-Label Arm (6-11 Years) Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol (CZP) in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)

ClinicalTrials.gov ID

NCT04123795

Sponsor

UCB Biopharma SRL

Study Description

  • Brief Summary:

    The purpose of the study is to demonstrate the efficacy and safety of certolizumab pegol in the treatment of moderate to severe chronic plaque psoriasis in study participants aged 6 to 11 and 12 to 17 years.

  • Condition or Disease:

    Moderate Chronic Plaque Psoriasis,Severe Chronic Plaque Psoriasis,Mixed Guttate/Plaque Psoriasis

  • Intervention/Treatment:

    Drug: Certolizumab pegol Drug: Certolizumab pegol,Drug: Placebo Drug: Certolizumab pegol
  • Phase:

    PHASE3

  • Ages Eligible for Study:

    6 Years and 17 Years (CHILD)

  • Sexes Eligible for Study:

    ALL

Youth aged 12 to 17 years old diagnosed with chronic plaque psoriasis for at least 6 months, may qualify to participate.  Individuals must have moderate to severe plaque psoriasis involving 10% or more body surface area (BSA), and a body weight of 20 kg or more.


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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