A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Study Identifier
M17-377
CT.gov Identifier
NCT03661138
EudraCT Identifier
2022-002777-29
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Plain Language Summary
Available Language(s): English, Japanese
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Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Dermatology - Atopic Dermatitis
    • Study Drug
  • Upadacitinib
  • Placebo for upadacitinib
  • Topical Corticosteroids (TCS)
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    12 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus. * Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis. * Able to tolerate topical corticosteroids for atopic dermatitis lesions.
    Exclusion Criteria:
    * Prior exposure to any Janus kinase (JAK) inhibitor. * Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study. * Requirement of prohibited medications during the study. * Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

    Protocol Summary

    The objective of this study is to assess the safety of upadacitinib combined with topical corticosteroids (TCS) in adolescent and adult participants in Japan with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

    Study Locations

    Location
    Status
    Location
    Ichinomiya Municipal Hospital /ID# 205942
    Ichinomiya-shi, Aichi-ken, Japan, 491-8558
    Status
    Not applicable
    Location
    Central Clinic /ID# 206558
    Nagoya, Aichi-ken, Japan, 464-0821
    Status
    Not applicable
    Location
    Nagoya City University Hospital /ID# 207566
    Nagoya, Aichi-ken, Japan, 467-8602
    Status
    Not applicable
    Location
    Yasumoto Dermatology Clinic /ID# 206480
    Chikushino-shi, Fukuoka, Japan, 818-0083
    Status
    Not applicable
    Location
    Kiryu Dermatology Clinic /ID# 206044
    Fukuoka, Fukuoka, Japan, 813-0044
    Status
    Not applicable
    Location
    Medical Corporation Matsuo Clinic /ID# 207323
    Fukuoka, Fukuoka, Japan, 819-0373
    Status
    Not applicable
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