Clinical trial NCT05750823: A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo
Official title: An Open-Label, Phase 2, Safety, and Efficacy Study of Ruxolitinib Cream in Participants With Genital Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonsegmental Vitiligo With Genital Involvement
Keywords: Vitiligo
Genital Vitiligo
INCB18424
Ruxolitinib Cream
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2023-03-02
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5
timeFrame: Week 48
Secondary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: 52 weeks
measure: Proportion of participants achieving Genital- Physician Global Vitiligo Assessment (PhGVA)
timeFrame: Week 48
measure: Change from baseline in affected Body Surface Area BSA in the genital region
timeFrame: Week 24 and 48
measure: Proportion of participants achieving T-VASI50/75/90
timeFrame: Week 24 and 48
measure: Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5
timeFrame: Week 24
measure: Proportion of participants in each category of the color-matching question
timeFrame: Week 24 and 48
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc
state: California
city: Los Angeles
country: United States
facility: Vitiligo & Pigmentation Institute of Southern California
state: California
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Mayfield
country: United States
facility: Apex Clinical Research Center
state: Ohio
city: Pflugerville
country: United States
facility: Austin Institute For Clinical Research Aicr Pflugerville
state: Texas
city: Plano
country: United States
facility: Innovative Dermatology: Legacy Medical Village
state: Texas
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Barrie
country: Canada
facility: Simcomed Health Ltd
state: Ontario
city: Peterborough
country: Canada
facility: Skin Centre For Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Creteil
country: France
facility: Hopital Henri Mondor Service de Dermatologie
city: Nice
country: France
facility: Chu Nice Hopital Archet 2
Study officials:
References: