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

Completed · Phase 3

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT04435600

Run by

AbbVie

People needed

139

Starts

2020-07-14

Expected to finish

2024-10-15

Last updated by the study team

2025-05-20

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify 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.

Where it is running

• First OC Dermatology /ID# 217733 — Fountain Valley, California, United States
• Integrative Skin Science and Research /ID# 221741 — Sacramento, California, United States
• University of California San Diego - Rady Children's Hospital San Diego /ID# 217906 — San Diego, California, United States
• Rybear, Inc /ID# 223164 — Fort Lauderdale, Florida, United States
• Solutions Through Adv Rch /ID# 217936 — Jacksonville, Florida, United States
• Olympian Clinical Research- St. Petersburg /ID# 217941 — St. Petersburg, Florida, United States
• Advanced Clinical Research Institute /ID# 222706 — Tampa, Florida, United States
• University Dermatology and Vein Clinic, LLC /ID# 222778 — Darien, Illinois, United States
• Duplicate_Arlington Dermatology /ID# 217472 — Rolling Meadows, Illinois, United States
• Duplicate_Skin Cancer and Dermatology Institute (SCDI) /ID# 221738 — Reno, Nevada, United States
• Duplicate_Forest Hills Dermatology Group /ID# 227941 — Kew Gardens, New York, United States
• Univ Hosp Cleveland /ID# 228483 — Cleveland, Ohio, United States
• The Ohio State University /ID# 217808 — Columbus, Ohio, United States
• Apex Clinical Research Center /ID# 228537 — Mayfield Heights, Ohio, United States
• Vital Prospects Clinical Research Institute, PC /ID# 217960 — Tulsa, Oklahoma, United States
• Medical University of South Carolina /ID# 217735 — Charleston, South Carolina, United States
• Arlington Research Center, Inc /ID# 217471 — Arlington, Texas, United States
• West Virginia University Hospitals /ID# 228352 — Morgantown, West Virginia, United States
• Clinical Investigation Specialist, Inc - Kenosha /ID# 223161 — Kenosha, Wisconsin, United States
• Wisconsin Medical Center /ID# 240005 — Milwaukee, Wisconsin, United States
• Duplicate_Dermatology Research Institute Inc. /ID# 226172 — Calgary, Alberta, Canada
• Karma Clinical Trials /ID# 226177 — St. John's, Newfoundland and Labrador, Canada
• Hospital for Sick Children /ID# 226167 — Toronto, Ontario, Canada
• CHU Sainte-Justine /ID# 226170 — Montreal, Quebec, Canada
• UAB Department of Dermatology /ID# 218834 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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