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A Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects with Moderate to Severe Atopic Dermatitis (AD) and Inadequate Response to Dupilumab (SWITCH-UP)

Clinical Trial Details

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 who 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. 

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 who 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

As a courtesy, patients will receive $50 for each in-person visit.

Key Eligibility: 

Inclusion Criteria:

  1. Chronic AD with onset of symptoms at least 3 years
  2. Inadequate response to dupilumab treatment after at least 4 months of current use.

Exclusion Criteria: 

  1. Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline Visit or would interfere with assessment of AD lesions
  2. Two or more past episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;
  3. Participants with current or past history of infection including, Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV);

Detailed eligibility will be discussed when reaching out to the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Dermatology Research Team
(646) 962-2090
ann9055@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2407027728

ClinicalTrials.gov:

NCT06389136

Sponsor:

M24-601 (SWITCH-UP)

Status

Open to Enrollment

Age Group

Adult

Sponsor

Disease