A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis

Study Identifier
M16-046
CT.gov Identifier
NCT03738397
EudraCT Identifier
2018-002264-57
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
Download document(s)
Statistical Analysis Plan
Available Language(s): English
Download document(s)
Scientific Result Summary
Available Language(s): English
Download document(s)
Plain Language Summary
Available Language(s): English, German, Chinese (Taiwan), Dutch, Polish
Download document(s)

Study Details

Medical Condition
  • Dermatology - Atopic Dermatitis
    • Study Drug
  • Upadacitinib
  • Dupilumab
  • Placebo to dupilumab
  • Placebo to upadacitinib
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 76 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI) ≥ 16, Investigator's Global Assessment (IGA) ≥ 3, ≥ 10% body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and Baseline weekly average of daily Worst Pruritus NRS ≥ 4. * Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.
    Exclusion Criteria:
    * Participant has prior exposure to Janus Kinase (JAK) inhibitor. * Participant has prior exposure to dupilumab. * Participant is unable or unwilling to discontinue current AD treatments prior to the study. * Participant has requirement of prohibited medications during the study. * Participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of AD lesions. * Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

    Protocol Summary

    This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

    Study Locations

    Location
    Status
    Location
    Clinical Research Center AL /ID# 210277
    Birmingham, Alabama, United States, 35209-6802
    Status
    Not applicable
    Location
    University of Arkansas for Medical Sciences /ID# 211688
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    Tien Q Nguyen MD, Inc /ID# 208934
    Fountain Valley, California, United States, 92708-3701
    Status
    Not applicable
    Location
    UCSF Fresno /ID# 213253
    Fresno, California, United States, 93701-2302
    Status
    Not applicable
    Location
    Jonathan Corren, MD. INC /ID# 208987
    Los Angeles, California, United States, 90025-4749
    Status
    Not applicable
    Location
    California Allergy and Asthma Medical Group /ID# 213680
    Los Angeles, California, United States, 90025-7014
    Status
    Not applicable
    Showing {first} - {last} of {total} Results