Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)

• ClinicalTrials.gov Identifier: NCT04052425
• Recruitment Status: Active, not recruiting
• First Posted: August 9, 2019
• Last Update Posted: November 12, 2020
• Sponsor: Incyte Corporation
• Information provided by (Responsible Party): Incyte Corporation

Study Description

Brief Summary:

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

Condition or disease	Intervention/treatment	Phase
Non-segmental Vitiligo	Drug: Ruxolitinib cream; Drug: Vehicle	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 330 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Participants will receive ruxolitinib cream or vehicle for 24 weeks, after which they will be offered the opportunity to continue in the treatment extension period. Participants initially randomized to vehicle will be crossed over to active drug, and participants treated with ruxolitinib cream will receive an additional 28 weeks of treatment with ruxolitinib cream.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo
• Actual Study Start Date: September 20, 2019
• Estimated Primary Completion Date: April 16, 2021
• Estimated Study Completion Date: November 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ruxolitinib cream; Ruxolitinib cream 1.5% twice daily (BID) for 24 weeks followed by ruxolitinib cream 1.5% BID for an additional 28-week treatment extension period.	Drug: Ruxolitinib cream; Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.; Other Name: INCB018424 cream
Placebo Comparator: Vehicle; Vehicle cream for 24 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 28-week treatment extension period.	Drug: Vehicle; Vehicle cream is a topical formulation applied as a thin film to affected areas.

Outcome Measures

Primary Outcome Measures :

1. Proportion of participants achieving F-VASI75 [ Time Frame: Week 24 ]
   ≥ 75% improvement from baseline in Face Vitiligo Area Scoring Index (F-VASI) score.

Secondary Outcome Measures :

1. Percentage change from baseline in facial body surface area (F-BSA) [ Time Frame: Week 24 ]
2. Proportion of participants achieving F-VASI50 [ Time Frame: Week 24 ]
   ≥ 50% improvement from baseline in F-VASI score.
3. Proportion of participants achieving F-VASI75 [ Time Frame: Week 52 ]
   ≥ 75% improvement from baseline in F-VASI score.
4. Proportion of participants achieving F-VASI90 [ Time Frame: Week 24 ]
   ≥ 90% improvement from baseline in F-VASI score.
5. Proportion of participants achieving F-VASI90 [ Time Frame: Week 52 ]
   ≥ 90% improvement from baseline in F-VASI score.
6. Proportion of participants achieving T-VASI50 [ Time Frame: Week 24 ]
   ≥ 50% improvement in total body Vitiligo Area Scoring Index (T-VASI).
7. Proportion of participants achieving T-VASI50 [ Time Frame: Week 52 ]
   ≥ 50% improvement in T-VASI.
8. Proportion of participants achieving T-VASI75 [ Time Frame: Week 52 ]
   ≥ 75% improvement in T-VASI.
9. Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) of "4 - A lot less noticeable" or "5 - No longer noticeable" [ Time Frame: Week 24 ]
10. Number of treatment-emergent adverse events [ Time Frame: Up to 56 weeks ]
    Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
11. Proportion of participants achieving F-VASI25/50/75/90 [ Time Frame: During the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
    ≥ 25%/ 50%/ 75%/90% improvement from baseline in F-VASI score.
12. Percentage change from baseline in F-VASI [ Time Frame: From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
13. Percentage change from baseline in F-BSA [ Time Frame: From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
14. Percentage change from baseline in T-VASI [ Time Frame: From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
15. Percentage change from baseline in total body surface area (T-BSA) [ Time Frame: From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
16. Proportion of participants achieving T-VASI25/50/75/90 [ Time Frame: During the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
    ≥ 25%/ 50%/ 75%/90% improvement in T-VASI.
17. Proportion of participants in each category of VNS [ Time Frame: During the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
18. Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 4 ]
19. Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 24 ]
20. Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 40 ]

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key Inclusion Criteria:

• Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI, and total body vitiligo area (facial and nonfacial) not exceeding 10% BSA.
• 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.
• Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.

Key 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).
• Have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
• Use of protocol-defined treatments within the indicated washout period before baseline.

Contacts and Locations

Locations

United States, Alabama

Cahaba Dermatology

Hoover, Alabama, United States, 35244

United States, Arizona

Cognitive Clinical Trials Scottsdale Btc Ppds

Scottsdale, Arizona, United States, 85260

United States, Arkansas

Burke Pharmaceutical Research

Hot Springs National Park, Arkansas, United States, 71913

United States, California

First Oc Dermatology

Fountain Valley, California, United States, 92708

Marvel Clinical Research Llc

Huntington Beach, California, United States, 92647

Rady Children'S Hospital - San Diego

San Diego, California, United States, 92123

University of California San Francisco Sub Location

San Francisco, California, United States, 94158

United States, Connecticut

Clinical Research Center of Ct

Danbury, Connecticut, United States, 06810

United States, Florida

Harmony Medical Research Institute

Hialeah, Florida, United States, 33016

San Marcus Research Clinic Inc.

Miami Lakes, Florida, United States, 33014

ForCare Medical Center

Tampa, Florida, United States, 33613

Forcare Clinical Research Fcr Forward Clinical Trials, Inc

Tampa, Florida, United States, 33624

Metabolic Research Institute Inc

West Palm Beach, Florida, United States, 33401

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

United States, Louisiana

Clinical Trials Management Llc

Metairie, Louisiana, United States, 70006

United States, Michigan

Great Lakes Research Group Inc

Bay City, Michigan, United States, 48706

Dermatology Specialists of Brighton

Brighton, Michigan, United States, 48114

United States, New York

Suny Downstate Medical Center

Brooklyn, New York, United States, 11203

Forest Hills Dermatology Group

Forest Hills, New York, United States, 11375

The Dermatology Specialists Greenwich

New York, New York, United States, 10012

United States, North Carolina

Wake Research Associates Llc

Raleigh, North Carolina, United States, 27612

Wake Forest University

Winston-Salem, North Carolina, United States, 27157

United States, Pennsylvania

Kgl Skin Study Center

Broomall, Pennsylvania, United States, 19008

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, United States, 19462

United States, South Carolina

Palmetto Clinical Trial Services

Anderson, South Carolina, United States, 29621

United States, Tennessee

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, United States, 37130

United States, Texas

Progressive Clinical Research

San Antonio, Texas, United States, 78213

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States, 78229

United States, Washington

Dermatology Specialists of Spokane

Spokane, Washington, United States, 99202

Bulgaria

Multiprofile Hospital For Active Treatement - Clinic of Dermatology and Venerology

Pleven, Bulgaria, 05800

DCC 28

Sofia, Bulgaria, 01592

Medical Center Eurohealth

Sofia, Bulgaria, 01606

Canada, Alberta

Dermatology Research Institute

Calgary, Alberta, Canada, T1Y 0B4

Institute For Skin Advancement

Calgary, Alberta, Canada, T3A 2N1

Canada, Ontario

Skin Centre For Dermatology

Peterborough, Ontario, Canada, K9J 5K2

Windsor Clinical Research Inc

Windsor, Ontario, Canada, N8W 5L7

Canada, Quebec

McGill University Health Centre / Carey/Wang Clinic

Montreal, Quebec, Canada, H3Z2S6

Siena Medical Reserch Corporation

Westmount, Quebec, Canada, H3Z 2S6

France

Centre Hospitalier Universitaire de Nantes

Nantes, France, 44000

Chu de Nice - Hopital L'Archet 1

Nice Cedex 3, France, 06202

Hopital Charles Nicolle Chu Rouen - Hopital de Bois-Guillaume

Rouen, France, 76031

Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol

Toulouse, France, 31059

Germany

University Clinic Carl Gustav Carus, Technical University Dresden

Dresden, Germany, 01307

Universitatsklinik Munster Dermatologie

Muenster, Germany, 48149

Italy

Presidio Ospedaliero Piero Palagi

Firenze, Italy, 50125

Istituto Dermatologico San Gallicano

Rome, Italy, 00144

Poland

Synexus - Polska Sp Z Oo Oddzial W Gdansk

Gdansk, Poland, 80-382

Synexus Polska Sp. Z O.O. Oddzial W Gdyni

Gdynia, Poland, 81-537

Synexus - Sp Z Oo Oddzial W Katowice

Katowice, Poland, 40-040

Dermedic Dr. Zdybski

Ostrowiec, Poland, 27-400

Synexus Polska Sp. Z O.O. Oddzial W Poznaniu

Poznan, Poland, 60-702

Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz

Torun, Poland, 87-100

Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu

Wroclaw, Poland, 50-381

Spain

Hospital Cima Sanitas

Barcelona, Spain, 08034

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Hospital Universitario San Cecilio

Granada, Spain, 18016

Clinica Universidad de Navarra (Cun)

Pamplona, Spain, 31008

Sponsors and Collaborators

Incyte Corporation

Investigators

• Study Director: Kathleen Butler, MD; Incyte Corporation

More Information

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT04052425
• Other Study ID Numbers: INCB 18424-306
• First Posted: August 9, 2019
• Last Update Posted: November 12, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:

Vitiligo; non-segmental; JAK inhibitor

Additional relevant MeSH terms:

Vitiligo; Hypopigmentation; Pigmentation Disorders; Skin Diseases