Lichen Sclerosus

A Study to evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus

Incyte Study ID:
INCB 18424-220
CT.gov ID:
NCT05593445
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
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Results Available

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 evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 12 weeks followed by an open label period (OLE) period of 12 weeks.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Lichen Sclerosus
    • PRODUCT
  • Drug: Ruxolitinib cream
  • Drug: Vehicle cream
    • COLLABORATORS
    N/A
    DATE
    Nov 2022 - Dec 2023
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female only
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    CLINIQUE RSF
    QUEBEC, QC, Canada, G1V 3M7
    Name
    K. PAPP CLINICAL RESEARCH
    WATERLOO, ON, Canada, N2J 1C4
    Name
    CAHABA DERMATOLOGY
    BIRMINGHAM, AL, US, 35244
    Name
    BEXLEY DERMATOLOGY
    BEXLEY, OH, US, 43209
    Name
    UC IRVINE
    IRVINE, CA, US, 92697
    Name
    MAYO CLINIC - SCOTTSDALE
    SCOTTSDALE, AZ, US, 85259
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    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Inclusion Criteria:
    • Biopsy-proven LS in the anogenital area.

    Exclusion Criteria

    Requirements information
    Inclusion Criteria
    • Inclusion Criteria:
    • Biopsy-proven LS in the anogenital area.
    • Baseline IGA score ≥ 2 for LS.
    • Baseline Itch NRS score ≥ 4 in anogenital area.
    • Willingness to avoid pregnancy.
    • Exclusion Criteria:
    • Participants who do not have LS involving anogenital area.
    • Concurrent conditions and history of other diseases:
    • a. Are suspected clinically (or confirmed diagnostically) of having alternative causes of
    • vaginal symptoms including: candidiasis, chlamydia trachomatis, trichomonas
    • vaginalis, neisseria gonorrhoeae, bacterial vaginosis, or herpes simplex.
    • b. Have active genital/vulvar lesions at screening and Day 1, not related to LS
    • c. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals,
    • antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
    • Laboratory values outside of the protocol-defined criteria
    • Pregnant or lactating participants or those considering pregnancy during the period of their study participation..
    • Other exclusion criteria may apply.

    Protocol Summary

    Incyte Study ID:
    INCB 18424-220
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Triple (Participant, Care Provider, Investigator)
    Interventions:
  • Drug: Ruxolitinib cream
  • Drug: Vehicle cream
    • Enrollment:
    61
    Primary Outcome
    Open

    Proportion of participants with ITCH4

    Timeframe: Week 12

    Secondary Outcome
    Open

    Change from baseline in Clinical Lichen Sclerosus Score (CLISSCO) score

    Timeframe: Week 12

    Change from baseline in the Skin Pain NRS score

    Timeframe: Week 12

    Time to achieve ITCH4

    Timeframe: Up to Week 24

    Number of Treatment Emergent Adverse Events (TEAEs))

    Timeframe: Up to 28 weeks