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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus

Conditions
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Lichen Sclerosus

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: 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: 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. Have active genital/vulvar lesions at screening and Day 1, not related to LS 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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 be a 12 week double-blind period followed by a 12 week open label period.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ruxolitinib cream<br>Ruxolitinib 1.5% cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an 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 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an 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 ITCH4 | ITCH4 response defined as a ≥ 4-point improvement in Itch Numerical Rating Scale (Itch NRS) from baseline | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Clinical Lichen Sclerosus Score (CLISSCO) score | The CLISSCO is a validated tool to assess disease severity in lichen sclerosus. Symptoms, signs, and architectural changes will be rated on a 4-point Likert scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe). | Week 12 | 
| Change from baseline in the Skin Pain 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. | Week 12 | 
| Time to achieve ITCH4 | ITCH4 response defined as a ≥ 4-point improvement in Itch Numerical Rating Scale (Itch NRS) from baseline | Up to Week 24 | 
| 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 28 weeks | 

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