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
- Registration Number
- NCT04862286
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 132
--Participants who have completed participation in study M19-977 and who meet all eligibility criteria for participation in Study M19-973 will be allowed to enroll in study M19-973.
--Participants who have developed any discontinuation criteria as defined in Study M19-977.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Risankizumab Risankizumab Participants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events Up to approximately 224 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
West Virginia University Hospitals /ID# 263438
🇺🇸Morgantown, West Virginia, United States
Wisconsin Medical Center /ID# 263437
🇺🇸Milwaukee, Wisconsin, United States
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 243908
🇩🇪Dresden, Sachsen, Germany
Kansai Medical University Hirakata Hospital /ID# 252332
🇯🇵Hirakata-shi, Osaka, Japan
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
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
Scroll for more (31 remaining)West Virginia University Hospitals /ID# 263438🇺🇸Morgantown, West Virginia, United States