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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
Sponsor: AbbVie
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. 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.
Official title: 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)
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2021-07-24
Completion Date
2028-04
Last Updated
2025-08-12
Healthy Volunteers
No
Conditions
Interventions
Risankizumab
Subcutaneous (SC) injection.
Locations (41)
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
Kansai Medical University Hirakata Hospital /ID# 252332
Hirakata-shi, Osaka, Japan
Tokyo Medical University Hospital /ID# 252331
Shinjuku-ku, Tokyo, Japan
High-Med Przychodnia Specjalistyczna /ID# 243846
Warsaw, Masovian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 243850
Rzeszów, Podkarpackie Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 243849
Gdansk, Pomeranian Voivodeship, Poland
Dermed Centrum Medyczne Sp. z o.o /ID# 243847
Lodz, Łódź Voivodeship, Poland
Dermoklinika Medical Center /ID# 243848
Lodz, Łódź Voivodeship, Poland
Hospital Sant Joan de Deu /ID# 241103
Esplugues de Llobregat, Barcelona, Spain
Hospital General Universitario Gregorio Maranon /ID# 241099
Madrid, Spain
Hospital Universitario Infanta Leonor /ID# 241100
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 241102
Madrid, Spain
Complejo Hospitalario Universitario de Pontevedra /ID# 241101
Pontevedra, Spain
Royal Devon & Exeter Hospital /ID# 245101
Exeter, Devon, United Kingdom
Derriford Hospital and the Royal Eye Infirmary /ID# 245104
Plymouth, Devon, United Kingdom
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 245100
London, Greater London, United Kingdom
Chelsea and Westminster Hospital /ID# 245102
London, Greater London, United Kingdom