Status:
COMPLETED
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
Lead Sponsor:
AbbVie
Conditions:
Psoriasis
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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 i...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2024
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT04435600
Start Date
July 14 2020
End Date
October 15 2024
Last Update
May 20 2025
Active Locations (53)
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1
UAB Department of Dermatology /ID# 218834
Birmingham, Alabama, United States, 35233
2
First OC Dermatology /ID# 217733
Fountain Valley, California, United States, 92708
3
Integrative Skin Science and Research /ID# 221741
Sacramento, California, United States, 95815
4
University of California San Diego - Rady Children's Hospital San Diego /ID# 217906
San Diego, California, United States, 92123