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
- ENROLLING_BY_INVITATION
- 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 (39)
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883
๐ฉ๐ชKiel, Schleswig-Holstein, Germany
First OC Dermatology /ID# 226942
๐บ๐ธFountain Valley, California, United States
Solutions Through Adv Rch /ID# 226104
๐บ๐ธJacksonville, Florida, United States
University Dermatology and Vein Clinic, LLC /ID# 226100
๐บ๐ธDarien, Illinois, United States
Olympian Clinical Research- St. Petersburg /ID# 226106
๐บ๐ธSaint Petersburg, Florida, United States
Arlington Dermatology /ID# 226097
๐บ๐ธRolling Meadows, Illinois, United States
Apex Clinical Research Center /ID# 248830
๐บ๐ธMayfield Heights, Ohio, United States
Hospital for Sick Children /ID# 233986
๐จ๐ฆToronto, Ontario, Canada
Universitaetsklinikum Muenster /ID# 243905
๐ฉ๐ชMuenster, Nordrhein-Westfalen, Germany
Universitaetsklinikum Bonn /ID# 243910
๐ฉ๐ชBonn, Nordrhein-Westfalen, Germany
Universitaetsmedizin Mainz /ID# 243907
๐ฉ๐ชMainz, Rheinland-Pfalz, Germany
Fachklinik Bad Bentheim /ID# 243904
๐ฉ๐ชBad Bentheim, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 243908
๐ฉ๐ชDresden, Germany
Kansai Medical University Hospital /ID# 252332
๐ฏ๐ตHirakata-shi, Osaka, Japan
Nagoya City University Hospital /ID# 248429
๐ฏ๐ตNagoya shi, Aichi, Japan
High-Med Przychodnia Specjalistyczna /ID# 243846
๐ต๐ฑWarszawa, Mazowieckie, Poland
Tokyo Medical University Hospital /ID# 252331
๐ฏ๐ตShinjuku-ku, Tokyo, Japan
Dermoklinika Medical Center /ID# 243848
๐ต๐ฑLodz, Lodzkie, Poland
Dermed Centrum Medyczne Sp. z o.o /ID# 243847
๐ต๐ฑLodz, Lodzkie, Poland
Hospital Sant Joan de Deu /ID# 241103
๐ช๐ธEsplugues de Llobregat, Barcelona, Spain
Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 243850
๐ต๐ฑRzeszow, Podkarpackie, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 243849
๐ต๐ฑGdansk, Pomorskie, Poland
Hospital General Universitario Gregorio Maranon /ID# 241099
๐ช๐ธMadrid, Spain
Hospital Universitario Infanta Leonor /ID# 241100
๐ช๐ธMadrid, Spain
Hospital Universitario 12 de Octubre /ID# 241102
๐ช๐ธMadrid, Spain
Guys and St Thomas NHS Foundation Trust /ID# 245100
๐ฌ๐งLondon, London, City Of, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust /ID# 245102
๐ฌ๐งLondon, United Kingdom
Skin Cancer and Dermatology Institute - Reno /ID# 248828
๐บ๐ธReno, Nevada, United States
Mie University Hospital /ID# 263008
๐ฏ๐ตTsu, Mie, Japan
Complejo Hospitalario Universitario de Pontevedra /ID# 241101
๐ช๐ธPontevedra, Spain
UAB Department of Dermatology /ID# 252305
๐บ๐ธBirmingham, Alabama, United States
Integrative Skin Science and Research /ID# 226108
๐บ๐ธSacramento, California, United States
University of California San Diego - Rady Children's Hospital San Diego /ID# 252348
๐บ๐ธSan Diego, California, United States
Advanced Clinical Research Institute /ID# 248827
๐บ๐ธTampa, Florida, United States
Univ Hosp Cleveland /ID# 248825
๐บ๐ธCleveland, Ohio, United States
Medical University of South Carolina /ID# 248831
๐บ๐ธCharleston, South Carolina, United States
Derriford Hospital and the Royal Eye Infirmary /ID# 245104
๐ฌ๐งPlymouth, Devon, United Kingdom
Karma Clinical Trials /ID# 233985
๐จ๐ฆSt. John's, Newfoundland and Labrador, Canada
Royal Devon & Exeter Hospital /ID# 245101
๐ฌ๐งExeter, Devon, United Kingdom