Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

Study Identifier
M19-850
CT.gov Identifier
NCT04195698
EudraCT Identifier
2019-001227-12
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
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Scientific Result Summary
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Plain Language Summary
Available Language(s): English, Dutch, German, Polish, Spanish, Ukrainian
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Study Details

Medical Condition
  • Dermatology - Atopic Dermatitis
    • Study Drug
  • Upadacitinib
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants should have successfully completed treatment in the M16-046 study, without meeting any permanent discontinuation criteria. * Participant is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the study M16-046 to continue treatment in the long term extension study.
    Exclusion Criteria:
    * Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions. * Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

    Protocol Summary

    This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed.

    Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.

    Study Locations

    Location
    Status
    Location
    University of Arkansas for Medical Sciences /ID# 221021
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    Duplicate_First OC Dermatology Research Inc /ID# 218619
    Fountain Valley, California, United States, 92708-3701
    Status
    Not applicable
    Location
    UCSF Fresno /ID# 218453
    Fresno, California, United States, 93701-2302
    Status
    Not applicable
    Location
    California Allergy and Asthma Medical Group /ID# 218635
    Los Angeles, California, United States, 90025-7014
    Status
    Not applicable
    Location
    Dermatology Research Associates /ID# 218637
    Los Angeles, California, United States, 90045
    Status
    Not applicable
    Location
    Dermatology Clinical Trials /ID# 218627
    Newport Beach, California, United States, 92660-7853
    Status
    Not applicable
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