Dermatitis

A study to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis (TRuE-AD3)

Incyte Study ID:
INCB 18424-305
CT.gov ID:
NCT04921969
View Results Summary
Eudra ID:
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 the study is to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis. This is a randomized, double-blind, Vehicle Controlled study. Participants will be randomized 2:2:1 to blinded treatment with ruxolitinib cream 0.75% ,1.5% , or vehicle cream, with stratification by baseline IGA score and age. At Week 8, efficacy will be evaluated. Participants who complete Week 8 assessments with no additional safety concerns will continue into the 44-week Long Term Safety (LTS) period with the same treatment regimen, except those initially randomized to vehicle cream will be rerandomized (1:1) in a blinded manner to 1 of the 2 active treatment groups (ruxolitinib cream 0.75% or 1.5%).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Dermatitis
    • PRODUCT
  • Drug: Ruxolitinib
  • Drug: Vehicle Cream
    • COLLABORATORS
    N/A
    DATE
    Jul 2021 - May 2023
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    2 - 11 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    ACEVEDO CLINICAL RESEARCH
    MIAMI, FL, US, 33142
    Name
    PROGRESSIVE CLINICAL RESEARCH
    SAN ANTONIO, TX, US, 78213
    Name
    DERMATOLOGY SPECIALISTS OF SPOKANE
    SPOKANE, WA, US, 99202
    Name
    PI COOR CLINICAL RESEARCH LLC
    BURKE, VA, US, 22015
    Name
    CLINICAL RESEARCH PARTNERS LLC
    RICHMOND, VA, US, 23220
    Name
    OHIO PEDIATRIC RESEARCH ASSOCIATION
    DAYTON, OH, US, 45414

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Participants diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin and Rajka criteria.
    • Participants with AD duration of at least 3 months (participant/parent/guardian may verbally report signs and symptoms of AD with onset at least 3 months prior).

    Exclusion Criteria

    • An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before the baseline visit.
    • Concurrent conditions and history of other diseases as follows:

    Protocol Summary

    Incyte Study ID:
    INCB 18424-305
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Triple (Participant, Care Provider, Investigator)
    Interventions:
    Drug
    Enrollment:
    330
    Primary Outcome
    Open

    Proportion of Participants who achieve Investigator's Global Assessment Treatment Success (IGA-TS)

    Timeframe: Week 8

    Secondary Outcome
    Open

    Proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score from baseline to Week 8

    Timeframe: Week 8

    Proportion of participants with a ≥ 4-point improvement in Itch NRS score from baseline to Day 7 (Week 1)

    Timeframe: Day 7 (Week 1)

    Proportion of participants with a ≥ 4-point improvement in Itch NRS score from baseline to Day 3

    Timeframe: Day 3

    Number of Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to 61 weeks

    Proportion of participants who achieve IGA-TS at Weeks 2 and 4

    Timeframe: Week 2 and 4

    Proportion of participants with a ≥ 4-point improvement in Itch NRS score from baseline to Weeks 2 and 4

    Timeframe: Weeks 2 and 4

    Proportion of participants who achieve EASI75 at Weeks 2, 4 and 8

    Timeframe: Weeks 2, 4 and 8

    Time to achieve Itch NRS score improvement of at least 2 or 4 points

    Timeframe: Week 8