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

Sponsor
Incyte Corporation (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05750823
Collaborator
(none)
45
1
24.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ruxolitinib Cream
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Phase 2, Safety, and Efficacy Study of Ruxolitinib Cream in Participants With Genital Vitiligo
Anticipated Study Start Date :
Mar 6, 2023
Anticipated Primary Completion Date :
Mar 28, 2025
Anticipated Study Completion Date :
Mar 28, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ruxolitinib Cream

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

Drug: Ruxolitinib Cream
Ruxolitinib cream will be applied twice daily for upto 48 weeks
Other Names:
  • Opzelura
  • Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5 [Week 48]

      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

    Secondary Outcome Measures

    1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) [52 weeks]

      Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

    2. Proportion of participants achieving Genital- Physician Global Vitiligo Assessment (PhGVA) [Week 48]

      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

    3. Change from baseline in affected Body Surface Area BSA in the genital region [Week 24 and 48]

      The BSA depigmented by vitiligo will be estimated at each visit.

    4. Proportion of participants achieving T-VASI50/75/90 [Week 24 and 48]

      ≥ 50%/75%/90% improvement in total body Vitiligo Area Scoring Index

    5. Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5 [Week 24]

      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

    6. Proportion of participants in each category of the color-matching question [Week 24 and 48]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT05750823
    Other Study ID Numbers:
    • INCB 18424-219
    First Posted:
    Mar 2, 2023
    Last Update Posted:
    Mar 2, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 2, 2023