Psoriasis
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Psoriasis
M19-977 Enrolling

Research Trial for Pediatric Plaque Psoriasis


Treatment: Injection 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.


The following information is from ClinicalTrials.gov

Last Update Posted: November 27, 2022

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:

    Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. There is an unmet medical need for effective treatment in pediatric patients and this study is being done to evaluate risankizumab in pediatric participants with moderate to severe plaque psoriasis. This study will assess the change in disease symptoms. Risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric participants. This study has 4 parts. Part 1: Participants aged 12 < 18 will receive a fixed dose of risankizumab. Part 2: Participants aged 12 < 18 will receive; Period A: Risankizumab or ustekinumab based on body weight followed by; Period B: Risankizumab or no treatment. Period C: Re-treatment with risankizumab (if needed). Part 3 and Part 4: Participants aged 6 < 12 will receive risankizumab based on body weight. Around 132 participants will be enrolled in approximately 50 sites worldwide. Risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection. Parts 1, 3, and 4: Risankizumab for 40 weeks with a follow-up call 20 weeks later for a study duration of approximately 65 weeks. Part 2: Period A: Risankizumab or ustekinumab for 16 weeks. Period B: Risankizumab or no treatment for 36 weeks. Period C: Re-treatment with risankizumab for 16 weeks. Follow-up call 20 weeks later for a study duration of approximately 81 weeks. Participants from each Part who meet eligibility criteria for an open-label extension (OLE) study may continue on risankizumab for 216 additional weeks. There may be a higher burden for study participants compared to standard treatment. Participants will attend monthly visits and medical assessments will check the effect of treatment through blood tests, questionnaires, and checking for side effects.

  • Condition or Disease:

    Psoriasis

  • Intervention/Treatment:

    Drug: Risankizumab
    Drug: Risankizumab
    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.


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.


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Alim Devani

Dermatologist

Dr. Vimal Prajapati

Dermatologist

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