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

  • STATUS
    Recruiting
  • End date
    Aug 7, 2025
  • participants needed
    132
  • sponsor
    AbbVie
Updated on 20 October 2022
Investigator
AbbVie_Call Center
Primary Contact
Karma Clinical Trials /ID# 226177 (3.5 mi away) Contact
+46 other location
systemic therapy
ustekinumab
inflammatory disease
risankizumab
plaque psoriasis

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.

Details
Condition Psoriasis
Treatment ustekinumab, risankizumab
Clinical Study IdentifierNCT04435600
SponsorAbbVie
Last Modified on20 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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