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

• ClinicalTrials.gov Identifier: NCT04052425
• Recruitment Status: Completed
• First Posted: August 9, 2019
• Results First Posted: September 21, 2022
• Last Update Posted: September 21, 2022
• 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
• Actual Primary Completion Date: March 18, 2021
• Actual Study Completion Date: October 21, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Double-Blind Period: Ruxolitinib cream 1.5% BID; Participants applied ruxolitinib 1.5% cream twice daily (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: Double-Blind Period: Vehicle cream BID; Participants applied matching vehicle cream BID for 24 weeks.	Drug: Vehicle; Vehicle cream is a topical formulation applied as a thin film to affected areas.
Experimental: Treatment-Extension Period: Ruxolitinib cream 1.5% BID; Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Drug: Ruxolitinib cream; Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.; Other Name: INCB018424 cream
Experimental: Treatment-Extension Period: Vehicle cream to Ruxolitinib cream 1.5% BID; Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period.	Drug: Ruxolitinib cream; Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.; Other Name: INCB018424 cream; Drug: Vehicle; Vehicle cream is a topical formulation applied as a thin film to affected areas.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24 [ Time Frame: Baseline; Week 24 ]
   An F-VASI75 responder achieved at least 75% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area [BSA]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).

Secondary Outcome Measures :

1. Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Week 24 [ Time Frame: Baseline; Week 24 ]
   An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
2. Percentage of Participants Achieving a ≥ 90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Week 24 [ Time Frame: Baseline; Week 24 ]
   An F-VASI90 responder achieved at least 90% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
3. Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24 [ Time Frame: Baseline; Week 24 ]
   A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).
4. Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) of 4 or 5 at Week 24 [ Time Frame: Baseline; Week 24 ]
   The VNS is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. The Baseline facial photograph was shown to the participants for reference, and a mirror was provided for the participants to assess the vitiligo on their face. The participant was asked to respond to the following query: Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, and (5) no longer noticeable.
5. Percentage Change From Baseline in Facial Body Surface Area (F-BSA) at Week 24 [ Time Frame: Baseline; Week 24 ]
   F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-Baseline (BL) value minus BL value]/BL value) X 100.
6. Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period [ Time Frame: from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 24) ]
   An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
7. Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Treatment-Extension Period [ Time Frame: from the completion of the Week 24 assessments until at least 30 days after the last application of study drug (up to Week 52 + 30 days) ]
   An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
8. Percentage of Participants Achieving a ≥ 25% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25) Score at Week 24 [ Time Frame: Baseline; Week 24 ]
   An F-VASI25 responder achieved at least 25% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
9. Percentage of Participants Achieving a ≥ %25, ≥ %50, ≥ 75%, and ≥ 90% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25/50/75/90) Score at Week 52 [ Time Frame: Baseline; Week 52 ]
   An F-VASI25/50/75/90 responder achieved at least 25/50/75/90% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
10. Percentage Change From Baseline in F-VASI at Week 24 [ Time Frame: Baseline; Week 24 ]
    F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100.
11. Percentage Change From Baseline in F-VASI at Week 52 [ Time Frame: Baseline; Week 52 ]
    F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100.
12. Percentage Change From Baseline in F-BSA at Week 52 [ Time Frame: Baseline; Week 52 ]
    F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-BL value minus BL value]/BL value) X 100.
13. Percentage Change From Baseline in T-VASI at Week 24 [ Time Frame: Baseline; Week 24 ]
    T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100.
14. Percentage Change From Baseline in T-VASI at Week 52 [ Time Frame: Baseline; Week 52 ]
    T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100.
15. Percentage Change From Baseline in T-BSA at Week 24 [ Time Frame: Baseline; Week 24 ]
    T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-BL value minus BL value]/BL value) X 100.
16. Percentage Change From Baseline in T-BSA at Week 52 [ Time Frame: Baseline; Week 52 ]
    T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-BL value minus BL value]/BL value) X 100.
17. Percentage of Participants Achieving a ≥ 25%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/75/90) Score at Week 24 [ Time Frame: Baseline; Week 24 ]
    A T-VASI25/75/90 responder achieved at least 25/75/90% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).
18. Percentage of Participants Achieving a ≥ 25%, ≥ 50%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/50/75/90) Score at Week 52 [ Time Frame: Baseline; Week 52 ]
    A T-VASI25/50/75/90 responder achieved ≥25/50/75/90% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).
19. Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) [ Time Frame: Baseline; Week 24 and Week 52 ]
    The VNS is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. The Baseline facial photograph was shown to the participants for reference, and a mirror was provided for the participants to assess the vitiligo on their face. The participant was asked to respond to the following query: Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, and (5) no longer noticeable.
20. Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24 [ Time Frame: Baseline; Week 24 ]
    The DLQI is a 10-question validated questionnaire for use in participants aged 16 years and over to measure how much the skin problem has affected the participant over the previous 7 days. Each question is scored as: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0. For Question 7, "Prevented work or studying" = 3. The DLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
21. Change From Baseline in DLQI at Week 52 [ Time Frame: Baseline; Week 52 ]
    The DLQI is a 10-question validated questionnaire for use in participants aged 16 years and over to measure how much the skin problem has affected the participant over the previous 7 days. Each question is scored as: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0. For Question 7, "Prevented work or studying" = 3. The DLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
22. Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) During the Treatment Period (Double-Blind and Treatment-Extension Periods) [ Time Frame: Baseline; Week 24 and Week 52 ]
    The DLQI is a 10-question validated questionnaire for use in participants aged 16 years and over to measure how much the skin problem has affected the participant over the previous 7 days. The CDLQI is the youth/children's version of the DLQI and was completed by adolescents aged ≥ 12 years to < 16 years. Each question is scored as: very much = 3; quite a lot = 2; only a little = 1; not at all = 0; question unanswered = 0. For Question 7: "Prevented school" = 3. The CDLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
23. Trough Plasma Concentrations of Ruxolitinib at Weeks 4, 24, and 40 [ Time Frame: pre-dose at Weeks 4, 24, and 40 ]
    Trough plasma concentration was defined as the measurement of the plasma concentration of ruxolitinib before drug application.

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

  Study Documents (Full-Text)

Documents provided by Incyte Corporation:

Study Protocol  [PDF] June 23, 2019

Statistical Analysis Plan  [PDF] March 9, 2021

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rosmarin D, Passeron T, Pandya AG, Grimes P, Harris JE, Desai SR, Lebwohl M, Ruer-Mulard M, Seneschal J, Wolkerstorfer A, Kornacki D, Sun K, Butler K, Ezzedine K; TRuE-V Study Group. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo. N Engl J Med. 2022 Oct 20;387(16):1445-1455. doi: 10.1056/NEJMoa2118828.

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT04052425
• Other Study ID Numbers: INCB 18424-306
• First Posted: August 9, 2019
• Results First Posted: September 21, 2022
• Last Update Posted: September 21, 2022
• Last Verified: August 2022

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