Summary

Eligibility
for people ages 6-17 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

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 30 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 52 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.

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

Keywords

Psoriasis Plaque Psoriasis Risankizumab Ustekinumab Biologic ABBV-066 SKYRIZI

Eligibility

You can join if…

Open to people ages 6-17

  • 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 PASI and 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.

You CAN'T join if...

  • 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.

Locations

  • UCSD Rady's Children's Hospital /ID# 217906 not yet accepting patients
    San Diego California 92123-4232 United States
  • Tien Q Nguyen MD, Inc /ID# 217733 accepting new patients
    Fountain Valley California 92708-3701 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT04435600
Phase
Phase 3
Study Type
Interventional
Last Updated