A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

Study Identifier
M19-977
CT.gov Identifier
NCT04435600
EudraCT Identifier
Not available
EUCTIS ID
2023-504156-10-00
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
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Statistical Analysis Plan
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Plain Language Summary
Available Language(s): English, German, Japanese, Polish, Spanish
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Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
    • Study Drug
  • Risankizumab
  • Ustekinumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    6 - 17 Years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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: Participants aged 6 \< 12 will receive risankizumab based on body weight.

    Part 4: Participants aged 6 \< 12 will receive risankizumab based on body weight (Japan only: Participants aged 12 \> 18 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.

    Study Locations

    Location
    Status
    Location
    UAB Department of Dermatology /ID# 218834
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    First OC Dermatology /ID# 217733
    Fountain Valley, California, United States, 92708
    Status
    Not applicable
    Location
    Integrative Skin Science and Research /ID# 221741
    Sacramento, California, United States, 95815
    Status
    Not applicable
    Location
    University of California San Diego - Rady Children's Hospital San Diego /ID# 217906
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    Rybear, Inc /ID# 223164
    Fort Lauderdale, Florida, United States, 33316-1952
    Status
    Not applicable
    Location
    Solutions Through Adv Rch /ID# 217936
    Jacksonville, Florida, United States, 32256
    Status
    Not applicable
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