Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoriasis Treated With Subcutaneous (SC) Injection of Risankizumab Who Have Completed Participation in Study M19-977

Running, not enrolling · 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. This study evaluates adverse events and change in disease activity with risankizumab in pediatric participants with moderate to severe plaque psoriasis who completed the study M19-977. Risankizumab is an approved drug for treatment of moderate to severe plaque psoriasis in adults and is being studied in the pediatric population (6 to 17 years). A maximum of 132 participants will be enrolled in the study across approximately 50 sites worldwide. Participants will receive subcutaneous injection of risankizumab every 12 weeks for 204 weeks and are followed up for safety for 20 weeks after last dose. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key facts

Study ID

NCT04862286

Run by

AbbVie

People needed

132

Starts

2021-07-24

Expected to finish

2028-04-01

Last updated by the study team

2025-08-12

Who can join

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

You may qualify if…

• -Participants who have completed participation in study M19-977 and who meet all eligibility criteria for participation in Study M19-973 will be allowed to enroll in study M19-973.

You may not qualify if…

• -Participants who have developed any discontinuation criteria as defined in Study M19-977.

Where it is running

• UAB Department of Dermatology /ID# 252305 — Birmingham, Alabama, United States
• First OC Dermatology /ID# 226942 — Fountain Valley, California, United States
• Integrative Skin Science and Research /ID# 226108 — Sacramento, California, United States
• University of California San Diego - Rady Children's Hospital San Diego /ID# 252348 — San Diego, California, United States
• Solutions Through Adv Rch /ID# 226104 — Jacksonville, Florida, United States
• Olympian Clinical Research- St. Petersburg /ID# 226106 — St. Petersburg, Florida, United States
• Advanced Clinical Research Institute /ID# 248827 — Tampa, Florida, United States
• University Dermatology and Vein Clinic, LLC /ID# 226100 — Darien, Illinois, United States
• Arlington Dermatology /ID# 226097 — Rolling Meadows, Illinois, United States
• Skin Cancer and Dermatology Institute - Reno /ID# 248828 — Reno, Nevada, United States
• Univ Hosp Cleveland /ID# 248825 — Cleveland, Ohio, United States
• Apex Clinical Research Center /ID# 248830 — Mayfield Heights, Ohio, United States
• Medical University of South Carolina /ID# 248831 — Charleston, South Carolina, United States
• West Virginia University Hospitals /ID# 263438 — Morgantown, West Virginia, United States
• Wisconsin Medical Center /ID# 263437 — Milwaukee, Wisconsin, United States
• Karma Clinical Trials /ID# 233985 — St. John's, Newfoundland and Labrador, Canada
• Hospital for Sick Children /ID# 233986 — Toronto, Ontario, Canada
• Fachklinik Bad Bentheim /ID# 243904 — Bad Bentheim, Lower Saxony, Germany
• Universitaetsklinikum Bonn /ID# 243910 — Bonn, North Rhine-Westphalia, Germany
• Universitaetsklinikum Muenster /ID# 243905 — Münster, North Rhine-Westphalia, Germany
• Universitaetsmedizin Mainz /ID# 243907 — Mainz, Rhineland-Palatinate, Germany
• Universitaetsklinikum Carl Gustav Carus Dresden /ID# 243908 — Dresden, Saxony, Germany
• Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883 — Kiel, Schleswig-Holstein, Germany
• Nagoya City University Hospital /ID# 248429 — Nagoya, Aichi-ken, Japan
• Mie University Hospital /ID# 263008 — Tsu, Mie-ken, Japan

Full record on ClinicalTrials.gov

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