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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Subcutaneous (SC) injection.
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
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Time frame: Up to approximately 224 weeks
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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
...and 31 more locations