Back to resultsA Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)
Primary Purpose
Vitiligo
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ruxolitinib cream
Vehicle Cream
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring Vitiligo, depigmenting disorder, topical JAK inhibitor
Eligibility Criteria
Inclusion Criteria
- A clinical diagnosis of nonsegmental vitiligo with depigmented areas including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, and ≥ 3 T-VASI; total body vitiligo area (facial and nonfacial) should not exceed 50% BSA.
- At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy.
- 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
- No pigmented hair within any of the vitiligo areas on the face.
- Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
- Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas except hydroquinone.
- Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
- Conditions at baseline that would interfere with evaluation of vitiligo.
- Use of any protocol-defined treatments within the indicated washout period before baseline.
Sites / Locations
- First Oc Dermatology
- UC Irvine
- George Washington Medical Faculty Associates
- Suny Downstate Medical Center
- Mount Sinai Hospital
- Dermatology Specialists of Spokane
- Dermatology Research Institute
- Simcoderm Medical and Surgical Dermatology Center
- Lynderm Research Inc
- JRB Research Inc
- Hopital Saint Andre
- Centre Hospitalier Universitaire Henri Mondor
- Hopital Archet 2 Derm Dept
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ruxolitinib cream
Vehicle Cream
Arm Description
Ruxolitinib cream will be administered twice a day (BID) for 24 weeks
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Outcomes
Primary Outcome Measures
To evaluate change in Immune Biomarkers
Percentage change from baseline in immune biomarkers, including CXCL10
Secondary Outcome Measures
Correlation of CXCL10 biomarker to Vitiligo Area Scoring Index (VASI) Repigmentation response in target lesions
Defined as correlation of change in biomarkers to VASI repigmentation measured at weeks 12 and 24.
Number of treatment emergency Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04896385
Brief Title
A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)
Official Title
A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action of Ruxolitinib Cream for Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
November 17, 2022 (Actual)
Study Completion Date
July 10, 2023 (Actual)
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
The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
Vitiligo, depigmenting disorder, topical JAK inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double-blind, vehicle-controlled, with an open-label treatment extension.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ruxolitinib cream
Arm Type
Experimental
Arm Description
Ruxolitinib cream will be administered twice a day (BID) for 24 weeks
Arm Title
Vehicle Cream
Arm Type
Placebo Comparator
Arm Description
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib cream
Other Intervention Name(s)
INCB018424 cream
Intervention Description
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Intervention Type
Drug
Intervention Name(s)
Vehicle Cream
Other Intervention Name(s)
Placebo
Intervention Description
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Primary Outcome Measure Information:
Title
To evaluate change in Immune Biomarkers
Description
Percentage change from baseline in immune biomarkers, including CXCL10
Time Frame
First 24 weeks of study
Secondary Outcome Measure Information:
Title
Correlation of CXCL10 biomarker to Vitiligo Area Scoring Index (VASI) Repigmentation response in target lesions
Description
Defined as correlation of change in biomarkers to VASI repigmentation measured at weeks 12 and 24.
Time Frame
First 24 weeks of study
Title
Number of treatment emergency Adverse Events
Description
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time Frame
56 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
A clinical diagnosis of nonsegmental vitiligo with depigmented areas including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, and ≥ 3 T-VASI; total body vitiligo area (facial and nonfacial) should not exceed 50% BSA.
At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy.
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
No pigmented hair within any of the vitiligo areas on the face.
Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas except hydroquinone.
Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
Conditions at baseline that would interfere with evaluation of vitiligo.
Use of any protocol-defined treatments within the indicated washout period before baseline.
Facility Information:
Facility Name
First Oc Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
UC Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
George Washington Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Suny Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Dermatology Specialists of Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Dermatology Research Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 0B4
Country
Canada
Facility Name
Simcoderm Medical and Surgical Dermatology Center
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Lynderm Research Inc
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
JRB Research Inc
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7X8
Country
Canada
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital Archet 2 Derm Dept
City
Nice
ZIP/Postal Code
06200
Country
France
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 Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)
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