Lichen Planus

A study to evaluate the efficacy and safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus

Incyte Study ID:
INCB 18424-216
CT.gov ID:
NCT05593432
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Clinical Study Purpose

The purpose of this study will be to evaluate efficacy and safety of Ruxolitinib cream in participants With Cutaneous Lichen Planus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 16 weeks followed by an open label period (OLE) period of 16 weeks.

Clinical Study Summary

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

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Clinical diagnosis of LP with predominant cutaneous involvement.
    • IGA score of 3 or 4 at screening and baseline.

    Exclusion Criteria

    • Concurrent conditions and history of other diseases:
    • a. Variants of LP deemed by the investigators to be inappropriate for topical treatment, including but not limited to predominant mucosal (such as oral or vaginal) LP.

    Clinical Study Locations

    Location
    Status
    Location
    WISEMAN DERMATOLOGY RESEARCH INC
    WINNIPEG, MB, Canada, R3M 3Z4
    Status
    Recruiting
    Location
    DR. S. K. SIDDHA MEDICINE PROFESSIONAL CORPORATION
    NEWMARKET, ON, Canada, L3Y 5G8
    Status
    Recruiting
    Location
    OREGON MEDICAL RESEARCH CENTER
    PORTLAND, OR, US, 97223
    Status
    Recruiting
    Location
    ARLINGTON CENTER FOR DERMATOLOGY
    ARLINGTON, TX, US, 76011-3800
    Status
    Recruiting
    Location
    BEXLEY DERMATOLOGY
    BEXLEY, OH, US, 43209
    Status
    Recruiting
    Location
    CAHABA DERMATOLOGY
    BIRMINGHAM, AL, US, 35244
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCB 18424-216
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Triple (Participant, Care Provider, Investigator)
    Interventions:
    Drug
    Enrollment:
    64
    Primary Outcome
    Open

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

    Timeframe: Week 16

    Secondary Outcome
    Open

    Proportion of Participants achieving IGA-TS

    Timeframe: Up to Week 32

    Proportion of Participants with ITCH4 response

    Timeframe: Up to Week 32

    Time to achieve ITCH4

    Timeframe: Up to Week 32

    Change from baseline in the Skin Pain Numeric Rating Scale (NRS) score

    Timeframe: Up to Week 32

    Number of Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to 36 weeks