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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04896385
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : November 11, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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 : June 23, 2021
Estimated Primary Completion Date : August 23, 2022
Estimated Study Completion Date : March 26, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

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 Name: 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 Name: Placebo




Primary Outcome Measures :
  1. To evaluate change in Immune Biomarkers [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 56 weeks ]
    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04896385


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
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United States, California
First Oc Dermatology Recruiting
Fountain Valley, California, United States, 92708
UC Irvine Recruiting
Irvine, California, United States, 92697
United States, Washington
Dermatology Specialists of Spokane Recruiting
Spokane, Washington, United States, 99202
Canada, Alberta
Dermatology Research Institute Recruiting
Calgary, Alberta, Canada, T1Y 0B4
Canada, Ontario
Simcoderm Medical and Surgical Dermatology Center Recruiting
Barrie, Ontario, Canada, L4M 7G1
Lynderm Research Inc Recruiting
Markham, Ontario, Canada, L3P 1X2
Jbr Research Inc Recruiting
Ottawa, Ontario, Canada, K1H 7X8
Sponsors and Collaborators
Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04896385    
Other Study ID Numbers: INCB 18424-214
First Posted: May 21, 2021    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Supporting Materials: Study Protocol
Statistical Analysis Plan (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.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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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:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases