The purpose of this study is to investigate the long-term safety and efficacy of risankizumab in the treatment of moderate to severe chronic plaque psoriasis.
This is a Phase 3, single-arm, multicenter open label extension (OLE) study designed to investigate the long-term safety and efficacy of 150 mg risankizumab in the treatment of moderate to severe chronic plaque psoriasis. Approximately 2200 participants who meet the entry criteria are planned to be enrolled in this study, rolling over from the preceding Phase 2/3 studies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2,170
Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events
An adverse event 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 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: Median follow-up time of 1905 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Total Skin and Beauty Dermatology Center /ID# 154000
Birmingham, Alabama, United States
University of Alabama at Birmingham - Main /ID# 153983
Birmingham, Alabama, United States
NW Arkansas Clinical Trials Center /ID# 154014
Rogers, Arkansas, United States
Bakersfield Derma & Skin Cance /ID# 154008
Bakersfield, California, United States
California Dermatology and Research Institute /ID# 154007
Encinitas, California, United States
T. Joseph Raoof, MD, Inc. /ID# 154078
Encino, California, United States
Center for Dermatology Clinical Research /ID# 154009
Fremont, California, United States
Kaiser Permanente Los Angeles /ID# 154079
Los Angeles, California, United States
Dermatology Research Associates /ID# 153977
Los Angeles, California, United States
Wallace Medical Group /ID# 154025
Los Angeles, California, United States
...and 223 more locations