Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)
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ClinicalTrials.gov Identifier: NCT04052425 |
Recruitment Status :
Active, not recruiting
First Posted : August 9, 2019
Last Update Posted : November 12, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-segmental Vitiligo | Drug: Ruxolitinib cream Drug: Vehicle | Phase 3 |
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 |

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.
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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.
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Drug: Vehicle
Vehicle cream is a topical formulation applied as a thin film to affected areas. |
- Proportion of participants achieving F-VASI75 [ Time Frame: Week 24 ]≥ 75% improvement from baseline in Face Vitiligo Area Scoring Index (F-VASI) score.
- Percentage change from baseline in facial body surface area (F-BSA) [ Time Frame: Week 24 ]
- Proportion of participants achieving F-VASI50 [ Time Frame: Week 24 ]≥ 50% improvement from baseline in F-VASI score.
- Proportion of participants achieving F-VASI75 [ Time Frame: Week 52 ]≥ 75% improvement from baseline in F-VASI score.
- Proportion of participants achieving F-VASI90 [ Time Frame: Week 24 ]≥ 90% improvement from baseline in F-VASI score.
- Proportion of participants achieving F-VASI90 [ Time Frame: Week 52 ]≥ 90% improvement from baseline in F-VASI score.
- Proportion of participants achieving T-VASI50 [ Time Frame: Week 24 ]≥ 50% improvement in total body Vitiligo Area Scoring Index (T-VASI).
- Proportion of participants achieving T-VASI50 [ Time Frame: Week 52 ]≥ 50% improvement in T-VASI.
- Proportion of participants achieving T-VASI75 [ Time Frame: Week 52 ]≥ 75% improvement in T-VASI.
- Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) of "4 - A lot less noticeable" or "5 - No longer noticeable" [ Time Frame: Week 24 ]
- 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.
- 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.
- 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. ]
- 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. ]
- 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. ]
- 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. ]
- 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.
- Proportion of participants in each category of VNS [ Time Frame: During the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
- Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 4 ]
- Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 24 ]
- Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 40 ]

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

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): NCT04052425

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 |
Study Director: | Kathleen Butler, MD | Incyte Corporation |
Responsible Party: | Incyte Corporation |
ClinicalTrials.gov Identifier: | NCT04052425 |
Other Study ID Numbers: |
INCB 18424-306 |
First Posted: | August 9, 2019 Key Record Dates |
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 |
Vitiligo non-segmental JAK inhibitor |
Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases |