A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis

Study Identifier
M16-813
CT.gov Identifier
NCT03706040
EudraCT Identifier
2021-002203-34
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Plain Language Summary
Available Language(s): English, Japanese, Spanish (United States)
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Study Details

Medical Condition
  • Dermatology - Atopic Dermatitis
    • Study Drug
  • Placebo
  • Risankizumab
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    12+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * adults who are ≥ 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old * a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to Baseline and subject meets Hanifin and Rajka criteria * moderate to severe AD at the Baseline Visit * history of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments
    Exclusion Criteria:
    * prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor * concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments

    Protocol Summary

    The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.

    Study Locations

    Location
    Status
    Location
    UAB Department of Dermatology /ID# 211561
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    Cognitive Clinical Trials /ID# 208895
    Scottsdale, Arizona, United States, 85258-4446
    Status
    Not applicable
    Location
    Cosmetic Dermatology of Orange County /ID# 205801
    Anaheim, California, United States, 92807-4780
    Status
    Not applicable
    Location
    Center for Dermatology Clinical Research /ID# 204950
    Fremont, California, United States, 94538
    Status
    Not applicable
    Location
    Integrative Skin Science and Research /ID# 212486
    Sacramento, California, United States, 95815-4500
    Status
    Not applicable
    Location
    Cosmetic Laser Dermatology /ID# 210560
    San Diego, California, United States, 92121-2119
    Status
    Not applicable
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