Dermatitis

Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE AD1) - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

Incyte Study ID:
INCB 18424-303
CT.gov ID:
NCT03745638
View Results Summary
Eudra ID:
2018-003712-45
EU CT Number:
N/A
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
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Statistical Analysis Plan (SAP)
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Clinical Study Purpose

The purpose of this study is to assess the efficacy and safety of twice daily 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 - Dec 2020
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    12+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    Elite Clinical Studies
    Phoenix, Arizona, US, 85018
    Name
    Northwest Arkansas Clinical Trials Center PLLC
    Rogers, Arkansas, US, 72758
    Name
    First OC Dermatology
    Fountain Valley, California, US, 92708
    Name
    Dermatology Research Associates
    Los Angeles, California, US, 90045
    Name
    Dermatology Specialists Inc
    Oceanside, California, US, 92056
    Name
    Stanford University
    Palo Alto, California, US, 94304
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    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:
    Requirements information
    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.
    • • AD duration of at least 2 years.
    • • Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and Baseline [Vehicle Controlled (VC) Period] and 0 to 4 at Week 8 [Long-Term Safety (LTS) Period].
    • • Participants with percentage of Body Surface Area (% BSA) (excluding scalp) of AD involvement of 3% to 20% at screening and Baseline (VC Period) and 0% to 20% at Week 8 (LTS Period).
    • • Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
    • • Participants who have at least 1 "target lesion" that measures approximately 10 cm^2 or more at screening and Baseline. Lesion must be representative of the participant's disease state and not be located on the hands, feet, or genitalia.
    • • Willingness to avoid pregnancy or fathering of children.
    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:
    • Immunocompromised.
    • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline.
    • Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline.
    • Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
    • Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds.
    • Other types of eczema.
    • • Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
    • • Use of any of the following treatments within the indicated washout period before Baseline:
    • 5 half-lives or 12 weeks, whichever is longer – biologic agents (eg. dupilumab).
    • 4 weeks – systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg. mycophenolate or tacrolimus).
    • 2 weeks – immunizations and sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted).
    • 1 week – use of other topical treatments for AD (other than bland emollients). Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.
    • • Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical.
    • • Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 2 weeks prior to Baseline and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD.
    • • Positive serology test results at screening for Human Immunodeficiency Virus (HIV) antibody.
    • • Liver function tests: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN); alkaline phosphatase and/or bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
    • • Pregnant or lactating participants, or those considering pregnancy.
    • • History of alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments.
    • • Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before Baseline with another investigational medication or current enrollment in another investigational drug protocol.

    Protocol Summary

    Incyte Study ID:
    INCB 18424-303
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Interventions:
  • Drug: Ruxolitinib Cream
  • Drug: Vehicle Cream
    • Enrollment:
    631
    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