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 Identifier
M19-973
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2022-500408-22-00
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Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
  • Study Drug
  • Risankizumab
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    6 - 17 Years

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    UAB Department of Dermatology /ID# 252305
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    First OC Dermatology /ID# 226942
    Fountain Valley, California, United States, 92708
    Status
    Not applicable
    Location
    Integrative Skin Science and Research /ID# 226108
    Sacramento, California, United States, 95815
    Status
    Not applicable
    Location
    University of California San Diego - Rady Children's Hospital San Diego /ID# 252348
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    Solutions Through Adv Rch /ID# 226104
    Jacksonville, Florida, United States, 32256
    Status
    Not applicable
    Location
    Olympian Clinical Research- St. Petersburg /ID# 226106
    St. Petersburg, Florida, United States, 33709-1405
    Status
    Not applicable
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