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

Last updated: October 18, 2022
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

3

Condition

Hand Dermatitis

Treatment

Vehicle

Ruxolitinib cream

Clinical Study ID

NCT05219864
INCB 18424-313
  • Ages 18-99
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Vehicle
Phase: 3
Study Start date:
January 31, 2023
Estimated Completion Date:
September 22, 2024

Study Description

Connect with a study center

  • CCA MEDICAL RESEARCH

    Ajax, Ontario L1S 7K8
    Canada

    Active - Recruiting

  • LYNDERM RESEARCH INC

    Markham, Ontario L3P 1X3
    Canada

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario Quironsalud Madrid

    Pozuelo De Alarcón, 28233
    Spain

    Active - Recruiting

  • FIRST OC DERMATOLOGY

    FOUNTAIN VALLEY, California 92708
    United States

    Active - Recruiting

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • JUVA Skin and Laser Center

    New York, New York 10022
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • INTERNATIONAL CLINICAL RESEARCH TENNESSEE LLC

    MURFREESBORO, Tennessee 37130
    United States

    Active - Recruiting

  • DERMATOLOGY SPECIALISTS OF SPOKANE

    SPOKANE, Washington 99202
    United States

    Active - Recruiting

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