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
Study ID:
M19-973ClinicalTrials.gov ID:
NCT04862286EudraCT ID:
Not AvailableEU CT ID:
2022-500408-22-00Call us @: 844 663-3742
Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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| Location | Status | Site Contact Details |
|---|---|---|
Location UAB Department of Dermatology, Birmingham, Alabama, 35233 | Status Not Available | |
Location First OC Dermatology, Fountain Valley, California, 92708 | Status Not Available | |
Location Integrative Skin Science and Research, Sacramento, California, 95815 | Status Not Available | |
Location University of California San Diego - Rady Children's Hospital San Diego, San Diego, California, 92123 | Status Not Available | |
Location Solutions Through Adv Rch, Jacksonville, Florida, 32256 | Status Not Available | |
Location Olympian Clinical Research- St. Petersburg, Saint Petersburg, Florida, 33709-1405 | Status Not Available | |
Location Advanced Clinical Research Institute, Tampa, Florida, 33607 | Status Not Available | |
Location University Dermatology and Vein Clinic, LLC, Darien, Illinois, 60561 | Status Not Available | |
Location Arlington Dermatology, Rolling Meadows, Illinois, 60008 | Status Not Available | |
Location Skin Cancer and Dermatology Institute - Reno, Reno, Nevada, 89509 | Status Not Available | |
Location Univ Hosp Cleveland, Cleveland, Ohio, 44106 | Status Not Available | |
Location Apex Clinical Research Center, Mayfield Heights, Ohio, 44124 | Status Not Available | |
Location Medical University of South Carolina, Charleston, South Carolina, 29425 | Status Not Available | |
Location Karma Clinical Trials, St. John's, Newfoundland and Labrador, A1A 4Y3 | Status Not Available | |
Location Hospital for Sick Children, Toronto, Ontario, M5G 1X8 | Status Not Available | |
Location Hospital General Universitario Gregorio Maranon, Madrid, 28007 | Status Not Available | |
Location Hospital Universitario Infanta Leonor, Madrid, 28031 | Status Not Available | |
Location Hospital Universitario 12 de Octubre, Madrid, 28041 | Status Not Available | |
Location Complejo Hospitalario Universitario de Pontevedra, Pontevedra, 36071 | Status Not Available | |
Location Royal Devon & Exeter Hospital, Exeter, Devon, EX2 5DW | Status Not Available | |
Location Derriford Hospital and the Royal Eye Infirmary, Plymouth, Devon, PL6 8DH | Status Not Available | |
Location Guys and St Thomas NHS Foundation Trust, London, London, City Of, SE1 9RT | Status Not Available | |
Location Chelsea and Westminster Hospital NHS Foundation Trust, London, SW10 9NH | Status Not Available |
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.
Number of Participants With Adverse Events
Time Frame: Up to approximately 224 weeks
- Not Available
Interventions:
- Drug: Risankizumab
Enrollment:
132
Additional Information
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