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 (NCT04862286)
OptIMMize-2: A Phase 3 Multicenter, Single-arm, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Risankizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Completed Participation in Study M19-977 (OptIMMize-1)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UAB Department of Dermatology /ID# 252305 — Birmingham, Alabama
Age range: 6 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (41 Sites)
Showing the first 25 of 41 sites.
- UAB Department of Dermatology /ID# 252305 — Birmingham, Alabama
- First OC Dermatology /ID# 226942 — Fountain Valley, California
- Integrative Skin Science and Research /ID# 226108 — Sacramento, California
- University of California San Diego - Rady Children's Hospital San Diego /ID# 252348 — San Diego, California
- Solutions Through Adv Rch /ID# 226104 — Jacksonville, Florida
- Olympian Clinical Research- St. Petersburg /ID# 226106 — St. Petersburg, Florida
- Advanced Clinical Research Institute /ID# 248827 — Tampa, Florida
- University Dermatology and Vein Clinic, LLC /ID# 226100 — Darien, Illinois
- Arlington Dermatology /ID# 226097 — Rolling Meadows, Illinois
- Skin Cancer and Dermatology Institute - Reno /ID# 248828 — Reno, Nevada
- Univ Hosp Cleveland /ID# 248825 — Cleveland, Ohio
- Apex Clinical Research Center /ID# 248830 — Mayfield Heights, Ohio
- Medical University of South Carolina /ID# 248831 — Charleston, South Carolina
- West Virginia University Hospitals /ID# 263438 — Morgantown, West Virginia
- Wisconsin Medical Center /ID# 263437 — Milwaukee, Wisconsin
- Karma Clinical Trials /ID# 233985 — St. John's, Newfoundland and Labrador
- Hospital for Sick Children /ID# 233986 — Toronto, Ontario
- Fachklinik Bad Bentheim /ID# 243904 — Bad Bentheim, Lower Saxony
- Universitaetsklinikum Bonn /ID# 243910 — Bonn, North Rhine-Westphalia
- Universitaetsklinikum Muenster /ID# 243905 — Münster, North Rhine-Westphalia
- Universitaetsmedizin Mainz /ID# 243907 — Mainz, Rhineland-Palatinate
- Universitaetsklinikum Carl Gustav Carus Dresden /ID# 243908 — Dresden, Saxony
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883 — Kiel, Schleswig-Holstein
- Nagoya City University Hospital /ID# 248429 — Nagoya, Aichi-ken
- Mie University Hospital /ID# 263008 — Tsu, Mie-ken
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Psoriasis Longitudinal Assessment and Registry — Birmingham, Alabama
- Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis — Birmingham, Alabama
- Prevention of Cardiovascular Disease and Mortality in Patients With Psoriasis or Psoriatic Arthritis — Scottsdale, Arizona
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.