A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

Study Identifier
M24-601
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2025-523347-35
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Study Details

Medical Condition
  • Dermatology - Atopic Dermatitis
  • Study Drug
  • Upadacitinib 15mg Dose
  • Dupilumab 300mg Dose
  • Upadacitinib 30mg Dose
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 63 Years

    Protocol Summary

    Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD.

    Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib 15mg or dupilumab 300mg. Based on the participants response to upadacitinib 15mg, they may have their dose increased to upadacitinib 30mg after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 200 adult participants ages 18 to less than 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 130 sites worldwide.

    The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days.

    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
    Skin Care Research - Tampa /ID# 263750
    Tampa, Florida, United States, 33607-6438
    4.9 miles (7.8 km) away from your location
    Status
    Recruiting
    Location
    Alliance Clinical Research of Tampa /ID# 264531
    Tampa, Florida, United States, 33615
    8.6 miles (13.8 km) away from your location
    Status
    Recruiting
    Location
    Apex Clinical Trials /ID# 263747
    Brandon, Florida, United States, 33511
    10.7 miles (17.1 km) away from your location
    Status
    Completed
    Location
    TrueBlue Clinical Research - Brandon /ID# 265037
    Brandon, Florida, United States, 33511
    10.7 miles (17.1 km) away from your location
    Status
    Recruiting
    Location
    Global Clinical Professionals (GCP) /ID# 266474
    St. Petersburg, Florida, United States, 33705
    18.4 miles (29.4 km) away from your location
    Status
    Recruiting