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

Primary Purpose

Nonsegmental Vitiligo With Genital Involvement

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ruxolitinib Cream
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonsegmental Vitiligo With Genital Involvement focused on measuring Vitiligo, Genital Vitiligo, INCB18424, Ruxolitinib Cream

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center For Dermatology Clinical Research, IncRecruiting
  • Vitiligo & Pigmentation Institute of Southern CaliforniaRecruiting
  • Hamzavi DermatologyRecruiting
  • Apex Clinical Research CenterRecruiting
  • Austin Institute For Clinical Research Aicr PflugervilleRecruiting
  • Innovative Dermatology: Legacy Medical Village
  • Dermatology Research InstituteRecruiting
  • Simcomed Health LtdRecruiting
  • Skin Centre For DermatologyRecruiting
  • Toronto Research CenreRecruiting
  • Centre Hospitalier Universitaire de Bordeaux
  • Hopital Henri Mondor Service de Dermatologie
  • Chu Nice Hopital Archet 2

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ruxolitinib Cream

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
Change from baseline in affected Body Surface Area BSA in the genital region
The BSA depigmented by vitiligo will be estimated at each visit.
Proportion of participants achieving T-VASI50/75/90
≥ 50%/75%/90% improvement in total body Vitiligo Area Scoring Index
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
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.

Full Information

First Posted
February 20, 2023
Last Updated
August 10, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05750823
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsegmental Vitiligo With Genital Involvement
Keywords
Vitiligo, Genital Vitiligo, INCB18424, Ruxolitinib Cream

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ruxolitinib Cream
Arm Type
Experimental
Arm Description
Participants with non-segmental vitiligo with genital involvement will receive ruxolitinib 1.5% cream BID for up to 48 weeks
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib Cream
Other Intervention Name(s)
Opzelura
Intervention Description
Ruxolitinib cream will be applied twice daily for upto 48 weeks
Primary Outcome Measure Information:
Title
Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5
Description
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
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Description
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time Frame
52 weeks
Title
Proportion of participants achieving Genital- Physician Global Vitiligo Assessment (PhGVA)
Description
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
Time Frame
Week 48
Title
Change from baseline in affected Body Surface Area BSA in the genital region
Description
The BSA depigmented by vitiligo will be estimated at each visit.
Time Frame
Week 24 and 48
Title
Proportion of participants achieving T-VASI50/75/90
Description
≥ 50%/75%/90% improvement in total body Vitiligo Area Scoring Index
Time Frame
Week 24 and 48
Title
Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5
Description
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
Time Frame
Week 24
Title
Proportion of participants in each category of the color-matching question
Description
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.
Time Frame
Week 24 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
eumedinfo@incyte.com
Facility Information:
Facility Name
Center For Dermatology Clinical Research, Inc
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Recruiting
Facility Name
Vitiligo & Pigmentation Institute of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Individual Site Status
Recruiting
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059-3526
Country
United States
Individual Site Status
Recruiting
Facility Name
Apex Clinical Research Center
City
Mayfield
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin Institute For Clinical Research Aicr Pflugerville
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Individual Site Status
Recruiting
Facility Name
Innovative Dermatology: Legacy Medical Village
City
Plano
State/Province
Texas
ZIP/Postal Code
75024-4319
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Dermatology Research Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Simcomed Health Ltd
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Skin Centre For Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Research Cenre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Bordeaux
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hopital Henri Mondor Service de Dermatologie
City
Creteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Chu Nice Hopital Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing 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.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

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

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