Eczema

Topical Ruxolitinib Evaluation in Chronic Hand Eczema

Incyte Study ID:
INCB 18424-226
CT.gov ID:
NCT05906628
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Clinical Study Purpose

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).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Eczema
    • PRODUCT
  • Drug: Ruxolitinib cream
  • Drug: Vehicle
    • COLLABORATORS
    N/A
    DATE
    Jul 2023 - Jul 2024
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    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.

    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).

    Clinical Study Locations

    Location
    Status
    Location
    CARE CLINIC
    RED DEER, AB, Canada, T4P-1K4
    Status
    Recruiting
    Location
    SIMCOMED HEALTH LTD
    BARRIE, ON, Canada, L4M 1G7
    Status
    Recruiting
    Location
    DERMATOLOGY RESEARCH INSTITUTE INC.
    CALGARY, AB, Canada, T2J 7E1
    Status
    Recruiting
    Location
    FACHKLINIK BAD BENTHEIM DERMATOLOGIE
    BAD BENTHEIM, Germany, 48455
    Status
    Recruiting
    Location
    DERMATOLOGISCHE GEMEINSCHAFTSPRAXIS MAHLOW
    MAHLOW, Germany, 15831
    Status
    Recruiting
    Location
    BELDIO RESEARCH GMBH
    MEMMINGEN, Germany, 87700
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCB 18424-226
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Triple (Participant, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    186
    Primary Outcome
    Open

    Proportion of participants achieving IGA-CHE-TS

    Timeframe: Week 16

    Secondary Outcome
    Open

    Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch Numerical Rating Scale (NRS) score

    Timeframe: Week 16

    Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score

    Timeframe: Week 4

    Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score

    Timeframe: Week 1 (Day 7)

    Proportion of participants achieving an IGA-CHE-TS from baseline

    Timeframe: Up to Week 32

    Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score

    Timeframe: Day 3

    Change from baseline in CHE-related Itch NRS score

    Timeframe: Up to Week 32

    Time to ≥ 4-point improvement from baseline in CHE-related Itch NRS score

    Timeframe: Up to Week 32

    Change from baseline in CHE-related Skin Pain NRS score

    Timeframe: Up to Week 32

    Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score

    Timeframe: Week 16

    Time to ≥ 2-point improvement from baseline in CHE-related Pain NRS score

    Timeframe: Up to Week 32

    Percentage change from baseline in Hand Eczema Severity Index (HECSI)

    Timeframe: Week 16

    Proportion of participants with each score on the PGIC

    Timeframe: Up to Week 32

    Change from baseline in DLQI score

    Timeframe: Up to week 32

    Change from baseline in EQ-5D-5L score

    Timeframe: Up to Week 32

    Change from baseline in QOLHEQ score

    Timeframe: Up to week 32, followed by 30 days follow-up

    Change from baseline in WPAI-ChHD

    Timeframe: Up to week 32, followed by 30 days follow-up

    Number of Participants with Treatment Emergent Adverse Events (TEAE)

    Timeframe: Up to week 32, followed by 30 days follow-up