Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)

• ClinicalTrials.gov Identifier: NCT04057573
• Recruitment Status: Completed
• First Posted: August 15, 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: 344 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 2 (TRuE-V2): 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: October 3, 2019
• Actual Primary Completion Date: March 15, 2021
• Actual Study Completion Date: October 1, 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 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). 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 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). 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, Arizona

Desert Sky Dermatology

Gilbert, Arizona, United States, 85295

United States, California

Center For Dermatology Cosmetic and Laser Surgery

Fremont, California, United States, 94538

Uci Beckman Laser Institute and Medical Clinic

Irvine, California, United States, 92617

UCI Health Beckman Laser Institute and Medical Center

Irvine, California, United States, 92697

Vitiligo & Pigmentation Institute of Southern California

Los Angeles, California, United States, 90036

Dermatology Research Associates

Los Angeles, California, United States, 90045

Dermatology Specialists Inc

Murrieta, California, United States, 92562

Dermatology Specialists Inc

Oceanside, California, United States, 92056

Integrative Skin Science and Research

Sacramento, California, United States, 95815

Acrc Studies

San Diego, California, United States, 92119

Central Sooner Research

San Diego, California, United States, 92123

United States, Colorado

Colorado Medical Research Center Inc

Denver, Colorado, United States, 80210

United States, Florida

Advanced Pharma Cr

Miami, Florida, United States, 33147

Leavitt Medical Associates of Florida

Ormond Beach, Florida, United States, 32174

Avita Clinical Research

Tampa, Florida, United States, 33613

Olympian Clinical Research

Tampa, Florida, United States, 33614

United States, Illinois

Ashira Dermatology Llc

Gurnee, Illinois, United States, 60031

United States, Indiana

Randall Dermatology of West Lafayette

West Lafayette, Indiana, United States, 47096

Randall Dermatology

West Lafayette, Indiana, United States, 47906

United States, Louisiana

Delricht Clinical Research - Clinedge - Ppds Baton Rouge

Baton Rouge, Louisiana, United States, 70809

United States, Massachusetts

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Tufts Medical Center

Boston, Massachusetts, United States, 02116

Metro Boston Clinical Partners

Brighton, Massachusetts, United States, 02135

University of Massachusetts

Worcester, Massachusetts, United States, 01655

United States, Michigan

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Henry Ford Medical Center

Detroit, Michigan, United States, 48202

United States, Minnesota

Minnesota Clinical Study Center

Minneapolis, Minnesota, United States, 55432

United States, Nevada

Jdr Dermatology Research

Las Vegas, Nevada, United States, 89148

United States, New York

Northwell Physician Partners

New Hyde Park, New York, United States, 11042

Icahn School of Medicine At Mount Sinai

New York, New York, United States, 10029

Derm Research Center of New York Inc

Stony Brook, New York, United States, 11790

United States, Oklahoma

Central Sooner Research

Norman, Oklahoma, United States, 73071

United States, Oregon

Oregon Medical Research Center

Portland, Oregon, United States, 97223

United States, Virginia

Clinical Research Partners Llc

Richmond, Virginia, United States, 23220

Bulgaria

Medical Center Unimed Eood

Sevlievo, Bulgaria, 05400

Medical Center Unimed EOOD

Sevlievo, Bulgaria, 5300

Diagnostic Consultative Center Ii Sofia Eood

Sofia, Bulgaria, 01000

University Multiprofile Hospital For Active Treatment Aleksandrovska

Sofia, Bulgaria, 01431

Diagnostic Consultative Center II Sofia EOOD

Sofia, Bulgaria, 1000

Diagnostic Consultative Center II Sofia EOOD

Sofia, Bulgaria, 1407

University Hospital Prof Dr Stoyan Kirkovich

Stara Zagora, Bulgaria, 06003

University Hospital " Prof. Dr Stoyan Kirkovich"

Stara Zagora, Bulgaria, 6003

Canada, Ontario

Simcoderm Medical and Surgical Dermatology Center

Barrie, Ontario, Canada, L4M 7G1

Kingsway Clinical Research

Etobicoke, Ontario, Canada, M8X 1Y9

Lynderm Research Inc

Markham, Ontario, Canada, L3P 1X2

K. Papp Clinical Research

Waterloo, Ontario, Canada, N2J 1C4

Xlr8 Medical Research

Windsor, Ontario, Canada, N8W 1E6

France

Centre Hospitalier Universitaire de Besancon

Besancon, France, 25000

CHU Besancon

Besancon, France, 25030

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France, 33000

CHU de Bordeaux, Hospital Saint Andre

Bordeaux, France, 33075

University Hospital Henri Mondor

Creteil, France, 94000

CENTRE HOSpITALIER UNIVERSITAIRE HENRI MONDOR

Creteil, France, 94010

Le Bateau Blanc

Martigues, France, 13500

Germany

Emovis GMBH

Berlin, Germany, 10629

Universitatsklinikum Bonn Aoer

Bonn, Germany, 53127

Hautarztpraxis Mahlow

Mahlow, Germany, 15831

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, Germany, 55131

University Medical Center (Universitätsmedizin der Johannes Gutenberg-Universität Mainz)

Mainz, Germany, 55131

Italy

Policlinico S. Orsola Malpighi

Bologna, Italy, 40138

Istituto Dermatologico San Gallicano

Rome, Italy, 00163

Netherlands

Amsterdam University Medical Centre

Amsterdam, Netherlands, 1105 AZ

Poland

Synexus Polska Sp. Z o.o. Oddział w Częstochowie

Czestochowa, Poland, 42-202

Synexus Affiliate - Krakowskie Centrum Medyczne

Krakow, Poland, 31-501

Synexus Polska Sp Z Oo Oddzial W Lodzi

Lodz, Poland, 90-127

Synexus Polska Sp Z Oo Oddzial W Czestochowie

Lublin, Poland, 20-081

Lubeskie Centrum Diagnostyczne

Swidnik, Poland, 21-040

High-Med Przychodnia Specjalistycza

Warsaw, Poland, 01-817

Synexus Polska Sp. Z O.O. Oddzial Warszawie

Warszawa, Poland, 01-192

Dermmedica Sp. Z O.O.

Wroclaw, Poland, 51-318

Spain

Ico Hospital Germans Trias I Pujol

Badalona, Spain, 08916

Hospital Universitari Germans Trias i Pujol

Barcelona, Spain, 8916

Dermomedic

Madrid, Spain, 28001

IDEI (Instituto de Dermatología Integral).

Madrid, Spain, 28010

Hospital La Paz (Hospital Universitario La Paz )

Madrid, Spain, 28046

Hospital Universitario de La Paz

Madrid, Spain, 28046

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: NCT04057573
• Other Study ID Numbers: INCB 18424-307
• First Posted: August 15, 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