Dermatitis

A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis

Incyte Study ID:
INCB 18424-102
CT.gov ID:
NCT03257644
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 safety, tolerability and the pharmacokinetics (PK) of topical ruxolitinib cream applied to pediatric subjects (age ≥ 2 to 17 years) with atopic dermatitis (AD).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Dermatitis
    • PRODUCT
  • Drug: Ruxolitinib phosphate cream
    • COLLABORATORS
    N/A
    DATE
    Sep 2017 - Oct 2020
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    2 - 17 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Pediatric subjects aged ≥ 2 to 17 years, inclusive
    • Subjects diagnosed with AD as defined by the Hanifin and Rajka criteria.

    Exclusion Criteria

    • Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before baseline.
    • Use of topical treatments for AD (other than bland moisturizer such as Eucerin® cream) within 2 weeks of baseline.

    Clinical Study Locations

    Location
    Status
    Location
    DESERT SKY DERMATOLOGY
    GILBERT, AZ, US, 85295
    Status
    Recruiting
    Location
    APPLIED RESEARCH CENTER OF ARKANSAS
    LITTLE ROCK, AR, US, 72212
    Status
    Recruiting
    Location
    CHILDREN'S HOSPITAL LOS ANGELES SPECIALT
    LOS ANGELES, CA, US, 90027
    Status
    Recruiting
    Location
    RADY CHILDREN'S HOSPITAL - SAN DIEGO
    SAN DIEGO, CA, US, 92123
    Status
    Recruiting
    Location
    NATIONAL JEWISH HEALTH
    DENVER, CO, US, 80206
    Status
    Recruiting
    Location
    ACEVEDO CLINICAL RESEARCH
    MIAMI, FL, US, 33142
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCB 18424-102
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    70
    Primary Outcome
    Open

    Participants with treatment-emergent adverse events (TEAEs)

    Timeframe: Screening through 30-37 days after end of treatment, up to approximately 12 weeks.

    Secondary Outcome
    Open

    Plasma concentrations of ruxolitinib for Cohorts 1 and 2

    Timeframe: Day 1, Day 15, and Day 29

    Plasma concentrations of ruxolitinib for Cohorts 3, 4, 5 and 6

    Timeframe: Day 1, Day 10, and Day 29