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

• Sponsor: Incyte Corporation (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04896385
• Collaborator: (none)
• Enrollment: 60
• Locations: 13
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site: 4.6
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vitiligo	Drug: Ruxolitinib cream; Drug: Vehicle Cream	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized, double-blind, vehicle-controlled, with an open-label treatment extension.Randomized, double-blind, vehicle-controlled, with an open-label treatment extension.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Double-blind
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action of Ruxolitinib Cream for Vitiligo
• Actual Study Start Date: Jun 23, 2021
• Anticipated Primary Completion Date: Nov 19, 2022
• Anticipated Study Completion Date: Jun 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ruxolitinib cream Ruxolitinib cream will be administered twice a day (BID) for 24 weeks	Drug: Ruxolitinib cream; Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.; Other Names: INCB018424 cream
Placebo Comparator: Vehicle Cream Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.	Drug: Vehicle Cream; Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. To evaluate change in Immune Biomarkers [First 24 weeks of study]

   Percentage change from baseline in immune biomarkers, including CXCL10

Secondary Outcome Measures

1. Correlation of CXCL10 biomarker to Vitiligo Area Scoring Index (VASI) Repigmentation response in target lesions [First 24 weeks of study]

   Defined as correlation of change in biomarkers to VASI repigmentation measured at weeks 12 and 24.

2. Number of treatment emergency Adverse Events [56 weeks]

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

Eligibility Criteria

Criteria

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Oc Dermatology	Fountain Valley	California	United States	92708
2	UC Irvine	Irvine	California	United States	92697
3	George Washington Medical Faculty Associates	Washington	District of Columbia	United States	20037
4	Suny Downstate Medical Center	Brooklyn	New York	United States	11203
5	Mount Sinai Hospital	New York	New York	United States	10029
6	Dermatology Specialists of Spokane	Spokane	Washington	United States	99202
7	Dermatology Research Institute	Calgary	Alberta	Canada	T1Y 0B4
8	Simcoderm Medical and Surgical Dermatology Center	Barrie	Ontario	Canada	L4M 7G1
9	Lynderm Research Inc	Markham	Ontario	Canada	L3P 1X2
10	JRB Research Inc	Ottawa	Ontario	Canada	K1H 7X8
11	Hopital Saint Andre	Bordeaux		France	33000
12	Centre Hospitalier Universitaire Henri Mondor	Creteil		France	94010
13	Hopital Archet 2 Derm Dept	Nice		France	06200

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: NCT04896385
• Other Study ID Numbers: INCB 18424-214
• First Posted: May 21, 2021
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• 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: Vitiligo; depigmenting disorder; topical JAK inhibitor
• Additional relevant MeSH terms: Vitiligo

Study Results

No Results Posted as of Mar 25, 2022