Psoriasis
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Psoriasis
M19-977 Enrolling

Research Trial for Pediatric Plaque Psoriasis


Age: 6 Years

Individuals aged 6 to less than 18 years old with a diagnosis of chronic plaque psoriasis for at least 6 months, may qualify to participate.

The study consists of 4 parts, each with distinct populations:

  • Part 1: for adolescents (aged 12 to less than 18 years old) with severe disease involving 20% or more body surface area (or 10% or more body surface area that includes facial or genital areas).
  • Part 2: for adolescents (aged 12 to less than 18 years old) with moderate to severe disease involving 10% or more body surface area.
  • Part 3: for children (aged 6 to less than 12 years old) with severe disease involving 20% or more body surface area (or 10% or more body surface area that includes facial or genital areas).
  • Part 4: for children (aged 6 to less than 12 years old) with moderate to severe disease involving 10% or more body surface area.

As the study progresses, some parts may no longer be enrolling.

Parts 1, 3, and 4 are open-label and all participants will receive investigational medication (active study drug), via injection. In Part 2, participants will receive one of two active study drugs during Period A; medication assignment may then change for Period B. Study medication and study-related procedures will be provided at no cost. Reimbursement for study-related expenses will also be provided.

Study participation in Parts 1, 3, and 4 will be about 65 weeks and involve about 9 visits to the study centre, plus a follow-up phone call.

In Part 2, study duration may be longer (81 weeks) and involve additional visits to the study centre.


Official Title

A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients From 6 to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov ID

NCT04435600

Sponsor

AbbVie

Study Description

  • Brief Summary:

    AbbVie

  • Condition or Disease:

    Psoriasis

  • Intervention/Treatment:

    Drug: Risankizumab Drug: Risankizumab,Drug: Ustekinumab Drug: Risankizumab Drug: Risankizumab Drug: Risankizumab
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    6 Years and 17 Years (Child)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Diagnosis of chronic plaque psoriasis for at least 6 months before the Baseline Visit.
Stable severe or moderate to severe plaque psoriasis as defined in each study part by body surface area (BSA) psoriasis involvement and scores on the Psoriasis Area and Severity Index (PASI) and Static Physician Global Assessment (sPGA).
Candidate for systemic therapy as assessed by the investigator and meet the disease activity criteria at both the Screening and Baseline Visits per the protocol.

Exclusion Criteria:

– Concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the participant’s participation in this study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk by participating in the study.


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Alim Devani

Dermatologist

Dr. Vimal Prajapati

Dermatologist

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