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

NCT05750823 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: INCB 18424-2192023-503737-22-00
• Study Type: interventional
• Target: 49
• Locations: 3 countries
• Sites: 13

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.

Conditions

Nonsegmental Vitiligo With Genital Involvement

Keywords

Vitiligo; Genital Vitiligo; INCB18424; Ruxolitinib Cream

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a Genital Vitiligo Noticeability Scale (VNS) of "4 - A Lot Less Noticeable" or "5 - No Longer Noticeable" at Week 48

  The VNS is a patient-reported measure of vitiligo treatment success that has a 5-point scale. The participant was asked to respond to the following query: "Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, or (5) no longer noticeable. The baseline genital photograph was shown to the participant for reference. A VNS score of 4 or 5 can be interpreted as representing treatment success.

  Baseline; Week 48

Secondary Outcomes (8)

• Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

  up to approximately 14 months

• Percentage of Participants Achieving Genital-Physician Global Vitiligo Assessment (PhGVA) of 0 or 1 at Week 48

  Week 48

• Change From Baseline in Affected Body Surface Area (BSA) in the Genital Region at Weeks 24 and 48

  Baseline; Weeks 24 and 48

• Percentage of Participants Achieving ≥50% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI50) at Weeks 24 and 48

  Baseline; Weeks 24 and 48

• Percentage of Participants Achieving ≥75% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI75) at Weeks 24 and 48

  Baseline; Weeks 24 and 48

Study Arms (1)

Ruxolitinib Cream

EXPERIMENTAL

Participants with non-segmental vitiligo with genital involvement will receive ruxolitinib 1.5% cream BID for up to 48 weeks

Drug: Ruxolitinib Cream

Interventions

Ruxolitinib Cream DRUG

Ruxolitinib cream will be applied twice daily for upto 48 weeks

Also known as: Opzelura

Ruxolitinib Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (13)

Center For Dermatology Clinical Research, Inc

Fremont, California, 94538, United States

Location

Vitiligo & Pigmentation Institute of Southern California

Los Angeles, California, 90036, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059-3526, United States

Location

Apex Clinical Research Center

Mayfield, Ohio, 44124, United States

Location

Austin Institute For Clinical Research Aicr Pflugerville

Pflugerville, Texas, 78660, United States

Location

Innovative Dermatology: Legacy Medical Village

Plano, Texas, 75024-4319, United States

Location

Dermatology Research Institute

Calgary, Alberta, T2J 7E1, Canada

Location

Simcomed Health Ltd

Barrie, Ontario, L4M 7G1, Canada

Location

Skin Centre For Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

Research Toronto

Toronto, Ontario, M3H 5Y8, Canada

Location

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33075, France

Location

Hopital Henri Mondor Service de Dermatologie

Créteil, 94000, France

Location

Chu Nice Hopital Archet 2

Nice, 06202, France

Location

MeSH Terms

Conditions

Vitiligo

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: April 11, 2023
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: March 20, 2026
• Results First Posted: March 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

US (6); CA (4); FR (3)