Dermatitis

A study to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to <18 Years Old) with moderate atopic dermatitis

Incyte Study ID:
INCB018424-316
CT.gov ID:
NCT06832618
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Will Be Recruiting
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Clinical Study Purpose

The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to <18 Years Old) with moderate atopic dermatitis.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Dermatitis
    • PRODUCT
  • Drug: Ruxolitinib
  • Drug: Vehicle Cream
    • COLLABORATORS
    N/A
    DATE
    May 2025 - Jul 2026
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    6 - 17 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    No locations found.

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Aged 6 to < 18 years at the VC Day 1 visit.
    • 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 the VC Day 1 visit.
    • Concurrent conditions and history of other diseases as follows:

    Protocol Summary

    Incyte Study ID:
    INCB018424-316
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    240
    Primary Outcome
    Open

    VC Period: Binary response status of Eczema Area and Severity Index 75 (EASI75)

    Timeframe: VC Week 8

    Secondary Outcome
    Open

    VC Period: Binary response status of Investigator's Global Assessment Treatment Success (IGA-TS)

    Timeframe: VC Week 8

    VC Period: Binary response status of ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)

    Timeframe: VC Week 8

    DC Period: Time to first disease exacerbation, defined as Investigator's Global Assessment score of ≥ 2 (DE) in the DC period

    Timeframe: Up to 44 Weeks

    Number of Treatment Emergent Adverse Events (TEAEs)

    Timeframe: From Baseline up to 70 weeks

    Binary response status of Eczema Area and Severity Index 75 (EASI75) at each postbaseline visit except Week 8

    Timeframe: Up to 44 weeks

    Binary response status of Investigator's Global Assessment Treatment Success (IGA-TS) at each postbaeline visit except Week 8

    Timeframe: Up to 44 weeks

    Binary response status of ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)

    Timeframe: Days 2, 3, and 7 and VC Weeks 2 and 4

    VC Period: Time to achieve ITCH4

    Timeframe: Up to 8 weeks

    VC Period: Binary response status of both EASI75 and IGA-TS at each postbaseline visit in the VC period

    Timeframe: Up to 44 weeks

    VC Period: The binary response status of DLQI-4/CDLQI-4 at VC Weeks 2, 4, and 8

    Timeframe: Weeks 2, 4 and 8

    VC Period and DC Period: Change from baseline in the CDLQI (or DLQI) score at each postbaseline visit

    Timeframe: Up to 52 weeks

    VC Period and DC Period: Change from baseline in the Patient-Oriented Eczema Measure (POEM) score at each postbaseline visit

    Timeframe: Up to 52 weeks

    VC Period and DC Period: Acceptability and tolerability assessment (exit interview/questionnaire)

    Timeframe: VC Period Week 8 and DC Period Week 44

    DC Period: Number of disease exacerbations (DEs)

    Timeframe: Up to 44 weeks

    DC Period: Amount of ruxolitinib cream used

    Timeframe: Up to 44 weeks

    VC Period: Plasma concentrations of ruxolitinib and PK parameters (Ctrough,ss)

    Timeframe: VC Week 2 and VC Week 8