Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1 (TRuE-CHE1): A Phase 3, Double-Blind, Randomized, 16-Week, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Open-Label Extension Period in Adults With Chronic Hand Eczema (TRuE-CHE1)

  • End date
    Sep 22, 2024
  • participants needed
  • sponsor
    Incyte Corporation
Updated on 23 October 2022


The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).

Condition Hand Eczema
Treatment Vehicle, Ruxolitinib cream
Clinical Study IdentifierNCT05219864
SponsorIncyte Corporation
Last Modified on23 October 2022


Yes No Not Sure

Inclusion Criteria

Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3 months or ≥ 2 flares within the previous 12 months
Screening and baseline IGA-CHE 3 or 4
Baseline CHE-related Itch NRS ≥ 4
Recent history (within the past 1 year of baseline) of inadequate response to treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or oral alitretinoin; or intolerance or contraindication to TCS or TCI or oral alitretinoin
Willingness to avoid pregnancy or fathering children based on the criteria below

Exclusion Criteria

Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study
Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline
Participants with concurrent conditions and history of other diseases such as other active skin disease or infection on the hands; immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with study assessments or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids; current or history of hepatitis B or C virus infection
Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data
Laboratory values outside of the protocol-defined criteria
Use of protocol-defined treatments within the indicated washout period before baseline
Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline
Pregnant or lactating participants, or those considering pregnancy during the period of their study participation
Further exclusion criteria apply
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