Dermatitis

Study of Ruxolitinib Cream in Adolescents with Atopic Dermatitis

Incyte Study ID:
INCB 18424-315
CT.gov ID:
NCT05456529
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 long-term safety and tolerability of ruxolitinib cream in adolescents with Atopic Dermatitis (AD).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Dermatitis
    • PRODUCT
  • Drug: Ruxolitinib Cream
    • COLLABORATORS
    N/A
    DATE
    Sep 2022 - May 2024
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    12 - 17 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • A diagnosis of Atopic Dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria.
    • Duration of AD of at least 2 years.

    Exclusion Criteria

    • An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
    • Concurrent conditions and history of other diseases

    Clinical Study Locations

    Location
    Status
    Location
    DR. CHIH-HO HONG MEDICAL INC.
    SURREY, BC, Canada, V3R 6A7
    Status
    Not yet recruiting
    Location
    K. PAPP CLINICAL RESEARCH
    WATERLOO, ON, Canada, N2J 1C4
    Status
    Recruiting
    Location
    XLR8 MEDICAL RESEARCH
    WINDSOR, ON, Canada, N8W 1E6
    Status
    Recruiting
    Location
    LMC MANNA RESEARCH (LONDON)
    LONDON, ON, Canada, N6A 2C2
    Status
    Recruiting
    Location
    KLINIKA AMBROZIAK
    WARSAW, Poland, 02-953
    Status
    Not yet recruiting
    Location
    CENTRUM MEDYCZNE ANGELIUS PROVITA
    KATOWICE, Poland, 40-611
    Status
    Not yet recruiting

    Protocol Summary

    Incyte Study ID:
    INCB 18424-315
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    103
    Primary Outcome
    Open

    Number of Treatment-emergent adverse events (TEAEs)

    Timeframe: Baseline up to 56 weeks

    Secondary Outcome
    Open

    Number of participants with clinically notable vital sign changes from baseline

    Timeframe: Baseline up to week 52

    Number of participants with clinically significant changes from Baseline in height

    Timeframe: Baseline up to week 52

    Number of participants with clinically significant changes from Baseline in weight

    Timeframe: Baseline up to week 52

    Number of participants with changes from baseline outside the normal range for clinically laboratory parameter values

    Timeframe: Baseline up to week 52

    Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations

    Timeframe: Predose at weeks 2, 4, 8 followed by every 8 weeks through end of treatment (weeks 12, 20, 28, 36, 44 and 52)