Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
INCB 18424-226 Enrolling

Clinical Trial for Chronic Hand Eczema (18 Months)


Treatment: Topical Age: 18 Years


Adults aged 18 years or older with a diagnosis of chronic hand eczema (CHE) for 6 months or more are needed for this clinical research trial.  Eligible participants must have hand eczema lasting for 3 months or more, or 2 or more reoccurences within the previous 12 months. Eligible participants must also have been treated with at least 1 prescription CHE therapy, unless such therapy was not advisable or contraindicated.

Participants will receive a treatment via a topical cream.  Study treatment and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses may be provided.


Participating Locations

COUNTRY
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Canada
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United States

Participating Experts

Dr. Maryam Shayesteh Alam

Dermatologist

Dr. Alim Devani

Dermatologist

Dr. Vimal Prajapati

Dermatologist

Dr. Matthew Zirwas

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: February 25, 2024

Official Title

A Phase 2, 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

ClinicalTrials.gov ID

NCT05906628

Sponsor

Incyte Corporation

Study Description

  • Brief 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).

  • Condition or Disease:

    Hand Eczema

  • Intervention/Treatment:

    Drug: Ruxolitinib cream
    Drug: Vehicle
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Diagnosis of CHE for at least 6 months prior to screening. 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.
Have been treated with at least 1 prescription CHE therapy or if such therapy was not advisable or contraindicated.
Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol.

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.
Any serious illness or medical, physical, or psychiatric condition(s).
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.

Other protocol-defined Inclusion/Exclusion Criteria may apply.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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