Dermatitis

A study to evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis

Incyte Study ID:
INCB18424-326
CT.gov ID:
NCT06238817
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
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Clinical Study Purpose

This study is being conducted to establish the efficacy of ruxolitinib cream in participants with moderate AD who had an inadequate

response to, or are intolerant to, or contraindicated to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Dermatitis
    • PRODUCT
  • Drug: Ruxolitinib Cream
  • Drug: Vehicle Cream
    • COLLABORATORS
    N/A
    DATE
    Apr 2024 - Aug 2025
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    SKIN HEALTH INSTITUTE INC.
    CARLTON, VIC, Australia, 03053
    Name
    CLINICAL TRIALS SA
    CAMPBELLTOWN, SA, Australia, 05074
    Name
    AUSTRALIAN CLINICAL RESEARCH NETWORK
    MAROUBRA, NSW, Australia, 02035
    Name
    PARATUS CLINICAL RESEARCH, WODEN
    PHILLIP, Australia, 02606
    Name
    VERACITY CLINICAL RESEARCH
    WOOLLOONGABBA, QLD, Australia, 04102
    Name
    PREMIER SPECIALISTS PTY LTD
    KOGARAH, NSW, Australia, 02217

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Adults aged ≥ 18 years at screening (Note: Legal adult age for Korea is ≥ 19 years).
    • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.

    Exclusion Criteria

    • Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Day 1.
    • Concurrent conditions and history of other diseases as follows:

    Protocol Summary

    Incyte Study ID:
    INCB18424-326
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    241
    Primary Outcome
    Open

    VC Period: Proportion of participants who achieved Eczema Area and Severity Index 75 (EASI75)

    Timeframe: Baseline to Week 8

    VC Period: Proportion of participants who achieved Investigator's Global Assessment Treatment Success (IGA-TS)

    Timeframe: Baseline to Week 8

    Secondary Outcome
    Open

    VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)

    Timeframe: Baseline to Week 8

    VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)

    Timeframe: Baseline to Day 7

    VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)

    Timeframe: Baseline to Day 3

    VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)

    Timeframe: Baseline to Day 2

    VC Period: Number of Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to Week 24, followed by 30 days follow-up

    VC Period: Proportion of participants who achieved Eczema Area and Severity Index 75 (EASI75)

    Timeframe: Baseline to Weeks 2 and 4

    VC Period: Proportion of participants who achieved Investigator's Global Assessment - Treatment Success (IGA-TS)

    Timeframe: Baseline to Weeks 2 and 4

    VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)

    Timeframe: Baseline to Weeks 2 and 4

    VC Period: Time to achieve a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)

    Timeframe: Baseline to Week 8

    VC Period: Time to achieve ≥ 2-point improvement from in Itch Numeric Rating Scale (NRS) score (ITCH2)

    Timeframe: Baseline to Week 8

    VC Period: Change from baseline (pre–study cream application) in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post–initial dose on Day 1.

    Timeframe: Baseline to Day 1

    VC Period: Proportion of participants achieving at least a 2-point decrease from baseline in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post–initial dose on Day 1.

    Timeframe: Baseline to Day 1

    VC Period: Proportion of participants achieving at least a 4-point decrease from baseline in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post–initial dose on Day 1.

    Timeframe: Baseline to Day 1

    VC and VCE Periods: Proportion of participants who achieved EASI50

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Periods: Proportion of participants who achieved EASI90

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Periods: Proportion of participants achieving both EASI75 and IGA-TS

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Periods: Change from Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Periods: Change from baseline in EASI score

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Periods: Change from baseline in SCORAD score

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Periods: Change from baseline in Itch NRS score

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Periods: Change from baseline in Skin Pain NRS score

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VCE Period: Time to open-label escape arm

    Timeframe: Baseline to Week 24

    VC and VCE Periods: Proportion of participants concurrently meeting all of the following criteria: IGA score ≥ 3, EASI score ≥ 16, Itch NRS score ≥ 4, BSA ≥ 10%, and DLQI score > 10

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Periods: Time to concurrently meeting all of the following criteria: IGA score ≥ 3, EASI score ≥ 16, Itch NRS score ≥ 4, BSA ≥ 10%, and DLQI score > 10

    Timeframe: Baseline to Week 24

    VC Period: Proportion of participants who experience a relapse after study treatment discontinuation

    Timeframe: Week 24 to Follow-up (30 days)

    VCE period: Time to first re-treatment

    Timeframe: Week 8 to Week 24

    VCE Period: Proportion of time off study treatment due to lesion clearance

    Timeframe: Week 8 to Week 24

    VCE period: Proportion of time on study treatment

    Timeframe: Week 8 to Week 24

    VC and VCE Periods: Proportion of participants who achieve ≥ 4-point improvement in DLQI from baseline

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Periods: Change From Baseline in Dermatology Life Quality Index (DLQI) Score

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Periods: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Periods: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Periods: Change from baseline in the HADS scores

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Periods: Change from baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score

    Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

    VC and VCE Periods: Change from baseline score in Work Productivity and Activity Impairment – Atopic Dermatitis (WPAI-AD)

    Timeframe: Baseline to Week 8 and Week 24