Eczema

Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2

Incyte Study ID:
INCB 18424-314
CT.gov ID:
NCT05233410
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
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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
    Jan 2023 - Apr 2024
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18 - 99 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    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.

    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.

    Clinical Study Locations

    Location
    Status
    Location
    DCC XXVIII
    SOFIA, Bulgaria, 01592
    Status
    Not yet recruiting
    Location
    DCC 'ALEXANDROVSKA', EOOD
    SOFIA, Bulgaria, 01431
    Status
    Not yet recruiting
    Location
    MEDICAL CENTER UNIMED EOOD
    SEVLIEVO, Bulgaria, 05402
    Status
    Not yet recruiting
    Location
    MEDICAL CENTER HERA EOOD
    SOFIA, Bulgaria, 01510
    Status
    Not yet recruiting
    Location
    MC 'SYNEXUS - SOFIA', EOOD
    SOFIA, Bulgaria, 01784
    Status
    Not yet recruiting
    Location
    DR. CHIH-HO HONG MEDICAL INC.
    SURREY, BC, Canada, V3R 6A7
    Status
    Not yet recruiting

    Protocol Summary

    Incyte Study ID:
    INCB 18424-314
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Triple (Participant, Care Provider, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    0
    Primary Outcome
    Open

    Percentage of Participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS)

    Timeframe: Week 16

    Secondary Outcome
    Open

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

    Timeframe: Baseline to Week 16

    Percentage of Participants with a ≥ 2-point improvement in CHE-related Skin Pain NRS score

    Timeframe: Baseline to Week 16

    Change from baseline in the mTLSS (modified Total Lesion Symptom Score

    Timeframe: Up to Week 32

    Percentage of Participants achieving an IGA CHE-TS

    Timeframe: Up to Week 32

    Change from baseline in CHE-related Itch NRS score (weekly average)

    Timeframe: Up to Week 32

    Change from baseline in CHE-related Skin Pain NRS score (weekly average)

    Timeframe: Up to Week 32

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

    Timeframe: Up to Week 32

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

    Timeframe: Up to Week 32

    Percentage change in Hand Eczema Severity Index (HECSI)

    Timeframe: Baseline to Week 16

    Percentage of participants with HECSI-75

    Timeframe: Weeks 2, 8, 16, 32

    Percentage of participants with HECSI-90

    Timeframe: Weeks 2, 8, 16, 32

    Mean Patient Global Impression of Change (PGIC) score

    Timeframe: Up to Week 32

    Percentage of participants with each score on the PGIC

    Timeframe: Up to Week 32

    Percentage of participants with a score of either 1 or 2 on the PGIC

    Timeframe: Up to Week 32

    Change from baseline in Dermatology Life Quality Index (DLQI) score

    Timeframe: Up to Week 32

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

    Timeframe: Up to Week 32

    Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) score

    Timeframe: Up to Week 32

    Change from baseline in Working Limitations Questionnaire (WLQ) score

    Timeframe: Up to Week 32

    Change from baseline in Work Productivity and Activity Impairment Questionnaire Specific Health Problem v2.0 in Chronic Hand Eczema (WPAI-SHP-CHE)

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

    Number of Participants with Treatment Emergent Adverse Events (TEAE)

    Timeframe: Up to 40 weeks