A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo

Study Overview
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Brief Summary
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An open-label study in which participants with non-segmental vitiligo with genital involvement will apply ruxolitinib 1.5% cream twice a day (BID) to all depigmented areas (up to 10% BSA) for up to 48 weeks. Participants should continue to treat depigmented areas identified for treatment at baseline regardless of whether the area begins to improve or fully repigment.

Official Title
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An Open-Label, Phase 2, Safety, and Efficacy Study of Ruxolitinib Cream in Participants With Genital Vitiligo

Conditions
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Nonsegmental Vitiligo With Genital Involvement

Intervention / Treatment
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* Drug: Ruxolitinib Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of nonsegmental vitiligo with genital involvement At least ≥ 0.25% BSA of nonsegmental vitiligo in the genital area. Pigmented hair within some of the genital vitiligo areas. At least 1 genital target lesion that is ≥ 0.1% BSA that has a pigmented hair within it. Vitiligo on areas of the body besides the genitals. Total body vitiligo area not exceeding 10% BSA. Willing to have genital photography conducted. Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted. Exclusion Criteria: Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders. Prior or current use of depigmentation treatments (eg, monobenzone). Active or recurrent genital warts or herpes. Male participants with partners with known current/active cervical intraepithelial neoplasia or anal intraepithelial neoplasia. An active sexually transmitted disease, sexually transmitted infection, or other skin disorder affecting the genital area (eg, scabies, fungal infection, molluscum). Had ≥ 3 laser hair removal treatments in an area to be treated for vitiligo. Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study or interpretation of study data. Clinical laboratory test results outside of protocol defined ranges Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ruxolitinib Cream<br>Participants with non-segmental vitiligo with genital involvement will receive ruxolitinib 1.5% cream BID for up to 48 weeks | Drug: Ruxolitinib Cream<br>* Ruxolitinib cream will be applied twice daily for upto 48 weeks<br>* Other names: Opzelura;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5 | Vitiligo Noticeable Score (VNS) is a patient-reported outcome measure on a scale of 1-5, 1- more noticeable, 4 - a lot less noticeable, and 5- no longer noticeable | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with 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. | 52 weeks | 
| Proportion of participants achieving Genital- Physician Global Vitiligo Assessment (PhGVA) | The severity of total body vitiligo will be assessed by the physician using the PhGVA on a scale of 0-4, 0 being clear to 4 being severe disease | Week 48 | 
| Change from baseline in affected Body Surface Area BSA in the genital region | The BSA depigmented by vitiligo will be estimated at each visit. | Week 24 and 48 | 
| Proportion of participants achieving T-VASI50/75/90 | ≥ 50%/75%/90% improvement in total body Vitiligo Area Scoring Index | Week 24 and 48 | 
| Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5 | Vitiligo Noticeable Score (VNS) is a patient-reported outcome measure on a scale of 1-5, 1- more noticeable, 4 - a lot less noticeable, and 5- no longer noticeable | Week 24 | 
| Proportion of participants in each category of the color-matching question | Participants will answer how well the color of the treated skin matches the normal skin on a scale of 1-5, 1 being excellent to 5 being very poor. | Week 24 and 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitiligo, Genital Vitiligo, INCB18424, Ruxolitinib Cream