A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)

NCT04896385 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: INCB 18424-2142021-000361-32
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 13

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.

Conditions

Vitiligo

Keywords

Vitiligo; depigmenting disorder; topical JAK inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24

  Baseline was defined as the last non-missing measurement obtained on or before the first application of study drug. Percentage change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] / Baseline value)\*100.

  Baseline; Week 4, Week 12, and Week 24

Secondary Outcomes (5)

• Correlation of Key Skin Inflammatory Biomarkers of Vitiligo in Target Lesions to Efficacy Readouts

  Baseline, Week 12, and Week 24

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period

  from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days)

• Number of Participants With TEAEs During the Treatment-Extension Period

  from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days

• Number of Participants With a Grade 3 or Higher TEAE During the Double-Blind Period

  from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days)

• Number of Participants With a Grade 3 or Higher TEAE During the Treatment-Extension Period

  from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days

Study Arms (2)

Ruxolitinib cream

EXPERIMENTAL

Ruxolitinib cream will be administered twice a day (BID) for 24 weeks

Drug: Ruxolitinib cream

Vehicle Cream

PLACEBO COMPARATOR

Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Drug: Vehicle Cream

Interventions

Ruxolitinib cream DRUG

Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

Also known as: INCB018424 cream

Ruxolitinib cream

Vehicle Cream DRUG

Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Also known as: Placebo

Vehicle Cream

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (13)

First Oc Dermatology

Fountain Valley, California, 92708, United States

Location

UC Irvine

Irvine, California, 92697, United States

Location

George Washington Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Suny Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Dermatology Research Institute

Calgary, Alberta, T1Y 0B4, Canada

Location

Simcoderm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X2, Canada

Location

JRB Research Inc

Ottawa, Ontario, K1H 7X8, Canada

Location

Hopital Saint Andre

Bordeaux, 33000, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Hopital Archet 2 Derm Dept

Nice, 06200, France

Location

MeSH Terms

Conditions

Vitiligo

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, vehicle-controlled, with an open-label treatment extension.

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 21, 2021
• Study Start: June 23, 2021
• Primary Completion: November 17, 2022
• Study Completion: July 10, 2023
• Last Updated: August 5, 2025
• Results First Posted: December 7, 2023

Record last verified: 2025-08

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

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