Dermatitis

Study of Ruxolitinib Cream in Adolescents with Atopic Dermatitis

Incyte Study ID:
INCB 18424-315
CT.gov ID:
NCT05456529
View Results Summary
Eudra ID:
N/A
EU CT Number:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
Subscribe to UpdatesContact Us

Results Available

Protocol
Available Languages: English
Download document(s)
Statistical Analysis Plan (SAP)
Available Languages: English
Download document(s)

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

    Clinical Study Locations

    Name
    Contact Us
    Name
    DR. CHIH-HO HONG MEDICAL INC.
    SURREY, BC, Canada, V3R 6A7
    Name
    K. PAPP CLINICAL RESEARCH
    WATERLOO, ON, Canada, N2J 1C4
    Name
    XLR8 MEDICAL RESEARCH
    WINDSOR, ON, Canada, N8W 1E6
    Name
    LMC MANNA RESEARCH (LONDON)
    LONDON, ON, Canada, N6A 2C2
    Name
    KLINIKA AMBROZIAK
    WARSAW, Poland, 02-953
    Name
    CENTRUM MEDYCZNE ANGELIUS PROVITA
    KATOWICE, Poland, 40-611
    Go to page

    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

    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: Ruxolitinib Cream
    • 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)