Dermatitis

TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

Incyte Study ID:
INCB 18424-304
CT.gov ID:
NCT03745651
View Results Summary
Eudra ID:
2018-003713-18
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Results Available

Plain Language Summary
Available Languages: English
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Protocol
Available Languages: English
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Statistical Analysis Plan (SAP)
Available Languages: English
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Clinical Study Purpose

The purpose of this study is to assess the efficacy of ruxolitinib cream in adolescents and adults with atopic dermatitis (AD).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Dermatitis
    • PRODUCT
  • Drug: Ruxolitinib cream
  • Drug: Vehicle cream
    • COLLABORATORS
    N/A
    DATE
    Dec 2018 - Sep 2020
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    12+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    University Of Alabama At Birmingham
    Birmingham, Alabama, US, 35233
    Name
    Center For Dermatology Cosmetic And Laser Surgery
    Fremont, California, US, 94538
    Name
    Marvel Clinical Research - Clinedge - PPDS
    Huntington Beach, California, US, 92647
    Name
    Allergy And Asthma Associates Of Southern California - CRN
    Mission Viejo, California, US, 92691
    Name
    Synexus Clinical Research US Inc. Santa Rosa
    Santa Rosa, California, US, 95405
    Name
    Olympian Clinical Research
    Largo, Florida, US, 33770

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Adolescents aged ≥ 12 to 17 years, inclusive, and men and women aged ≥ 18 years.
    • Participants diagnosed with atopic dermatitis (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 in the 4 weeks prior to Baseline.
    • Concurrent conditions and history of other diseases:

    Protocol Summary

    Incyte Study ID:
    INCB 18424-304
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    618
    Primary Outcome
    Open

    Proportion of participants achieving Investigator's Global Assessment Treatment Success (IGA-TS)

    Timeframe: From baseline up to 8 weeks

    Secondary Outcome
    Open

    Proportion of participants who achieve EASI75

    Timeframe: Up to 8 weeks

    Proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score

    Timeframe: Up to 8 weeks

    Proportion of participants with a clinically meaningful improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form – Sleep Disturbance (8b) 24-hour recall score

    Timeframe: Up to 8 weeks

    Participants with treatment-emergent adverse events (TEAEs)

    Timeframe: Up to 52 weeks

    Proportion of participants achieving an IGA-TS

    Timeframe: From baseline up to 4 weeks

    Proportion of participants achieving an IGA of 0 or 1 at each visit

    Timeframe: Up to 8 weeks

    Proportion of participants with a ≥ 4-point improvement in Itch NRS score

    Timeframe: Up to 4 weeks

    Proportion of participants who achieve EASI50 at each visit during the VC period.

    Timeframe: Up to 8 weeks

    Proportion of participants who achieve EASI75

    Timeframe: Up to 4 weeks

    Proportion of participants who achieve EASI90 at each visit during the VC period

    Timeframe: Up to 8 weeks

    Mean percentage change from baseline in EASI score at each visit during the VC period

    Timeframe: From baseline up to 8 weeks

    Mean percentage change from baseline in SCORAD score at each visit during the VC period

    Timeframe: From baseline up to 8 weeks

    Change from baseline in Itch NRS score at each visit during the VC period

    Timeframe: From baseline up to 8 weeks

    Time to achieve Itch NRS score improvement of at least 2, 3, or 4 points

    Timeframe: Up to 8 weeks

    Change from baseline in Skin Pain NRS score at each visit during the VC period

    Timeframe: From baseline up to 8 weeks

    Proportion of participants with a clinically meaningful improvement in the PROMIS Short Form – Sleep-Related Impairment (8a) 24-hour recall score

    Timeframe: Up to 8 weeks

    Change from baseline in PROMIS Short Form – Sleep Related Impairment (8a) 24-hour recall and Short Form – Sleep Disturbance (8b) 24-hour recall score

    Timeframe: From baseline up to 8 weeks

    PROMIS Short Form – Sleep-Related Impairment (8a) 7-day recall and Short Form – Sleep Disturbance (8b) 7-day recall score

    Timeframe: Up to 52 weeks

    Change from baseline in AD afflicted percentage of body surface area (%BSA) at every visit

    Timeframe: From baseline up to 52 weeks

    Change from baseline in Patient-Oriented Eczema Measure (POEM) score at each visit

    Timeframe: From baseline up to 52 weeks

    Change from baseline in Dermatology Life Quality Index (DLQI) score

    Timeframe: From baseline up to 52 weeks

    Mean Patient Global Impression of Change (PGIC) score

    Timeframe: Up to 8 weeks

    Proportion of participants with each score on the PGIC

    Timeframe: Up to 8 weeks

    Proportion of participants with a score of either 1 or 2 on the PGIC

    Timeframe: Up to 8 weeks

    Change from baseline in EQ-5D-5L score during the VC period

    Timeframe: From baseline up to 8 weeks

    Change from baseline in WPAI-SHP v2.0

    Timeframe: From baseline up to 52 weeks

    Trough plasma concentrations of ruxolitinib at all study visits

    Timeframe: Up to 52 weeks