A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus

Conditions
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Cutaneous Lichen Planus

Intervention / Treatment
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* Drug: Ruxolitinib cream
* Drug: Vehicle cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of LP with predominant cutaneous involvement. IGA score of 3 or 4 at screening and baseline. Baseline LP-related Itch NRS score ≥ 4. Willingness to avoid pregnancy or fathering children. Exclusion Criteria: Concurrent conditions and history of other diseases: 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. Active ongoing inflammatory diseases of the skin other than LP that might confound the evaluation of LP lesions or compromise participant safety. Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of LP lesions or compromise participant safety. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome). 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 (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, or impetigo) within 1 week 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 exclusive criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study will include a 16 week double-blind period followed by a 16 week open-label period.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ruxolitinib cream<br>Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension. | Drug: Ruxolitinib cream<br>* Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.<br>* Other names: INCB018424 cream;Drug: Vehicle cream<br>* Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.<br>|
| Placebo Comparator: Vehicle Cream<br>Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension. | Drug: Vehicle cream<br>* Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants with Investigator's Global Assessment Treatment Success (IGA-TS) | Defined as an IGA score of 0 or 1 with ≥ 2-grade improvement from baseline. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants achieving IGA-TS | Defined as the percentage of participants achieving IGA-TS at each scheduled postbaseline visit. | Up to Week 32 | 
| Proportion of Participants with ITCH4 response | Defined as a ≥ 4-point improvement in the Itch Numeric Rating Scale (Itch NRS) score from baseline. | Up to Week 32 | 
| Time to achieve ITCH4 | Time to achieve >=4 point improvement in Itch NRS score | Up to Week 32 | 
| Change from baseline in the Skin Pain Numeric Rating Scale (NRS) score | Defined as skin pain severity on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) in the past 24 hours. | Up to Week 32 | 
| Number of Treatment Emergent Adverse Events (TEAEs) | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. | Up to 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lichen Planus, Skin Diseases, 18424, Ruxolitinib, topical cream