Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

NCT04530344 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: INCB 18424-3082020-000987-53
• Study Type: interventional
• Target: 458
• Locations: 8 countries
• Sites: 84

Brief Summary

The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either Study NCT04052425 or NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream BID for the previous 28 to 52 weeks depending on their initial randomization in the parent study.

Conditions

Vitiligo

Keywords

INCB018424

Outcome Measures

Primary Outcomes (1)

• Time to Relapse (Defined as <F-VASI75)

  Relapse was defined as a loss of 75% improvement from Baseline in the Face Vitiligo Area Scoring Index score (F-VASI75) response, assessed as percentage improvement in the F-VASI score at Baseline (Day 1 of the parent study) to \<75%.

  from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study)

Secondary Outcomes (24)

• Time to Loss of Adequate Response

  from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study)

• Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period

  up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

• Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period

  up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

• Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period

  up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

• Mean F-VASI Scores During the Extension Treatment Period

  up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Study Arms (3)

Cohort A : ruxolitinib cream

EXPERIMENTAL

Participants who achieve complete or almost complete facial repigmentation (achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to ruxolitinib cream.

Drug: ruxolitinib

Cohort A : Vehicle

PLACEBO COMPARATOR

Participants who achieve complete or almost complete facial repigmentation (ie, achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to vehicle cream.

Drug: Vehicle

Cohort B : roxolitinib cream

EXPERIMENTAL

Participants who did not achieve ≥ F-VASI90 at Week 52 of the parent studies will be assigned to Cohort B and will continue ruxolitinib cream.

Drug: ruxolitinib

Interventions

ruxolitinib DRUG

ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.

Also known as: INCB018424 Cream

Cohort A : ruxolitinib cream; Cohort B : roxolitinib cream

Vehicle DRUG

Vehicle cream is a topical formulation applied as a thin film to affected areas.

Cohort A : Vehicle

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently enrolled and receiving treatment in INCB 18424-306 (NCT04052425) or INCB 18424-307 (NCT04057573) studies evaluating ruxolitinib cream in participants with vitiligo.
• Currently tolerating ruxolitinib cream in the parent study and no safety concerns per investigators judgment.
• Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
• Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.
• Male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child.
• Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and written assent from the participant when possible.

You may not qualify if:

• Has been permanently discontinued from study treatment in the parent study for any reason.
• Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
• Pregnant or breastfeeding woman.
• Participants who live with anyone participating in any current Incyte-sponsored ruxolitinib cream study.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (84)

Cahaba Dermatology

Hoover, Alabama, 35244, United States

Location

Desert Sky Dermatology

Gilbert, Arizona, 85295, United States

Location

First Oc Dermatology

Fountain Valley, California, 92708, United States

Location

Center For Dermatology Cosmetic and Laser Surgery

Fremont, California, 94538, United States

Location

Marvel Clinical Research Llc

Huntington Beach, California, 92647, United States

Location

Vitiligo & Pigmentation Institute of Southern California

Los Angeles, California, 90036, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Acrc Studies

San Diego, California, 92119, United States

Location

University of California San Francisco

San Francisco, California, 94158, United States

Location

Colorado Medical Research Center Inc

Denver, Colorado, 80210, United States

Location

Harmony Medical Research Institute

Hialeah, Florida, 33016, United States

Location

Advanced Pharma

Miami, Florida, 33147, United States

Location

San Marcus Research Clinic Inc.

Miami Lakes, Florida, 33014, United States

Location

Leavitt Medical Associates of Florida

Ormond Beach, Florida, 32174, United States

Location

Avita Clinical Research

Tampa, Florida, 33613, United States

Location

Olympian Clinical Research

Tampa, Florida, 33614, United States

Location

Forcare Clinical Research Fcr Forward Clinical Trials, Inc

Tampa, Florida, 33624, United States

Location

Metabolic Research Institute Inc

West Palm Beach, Florida, 33401, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Randall Dermatology

West Lafayette, Indiana, 47906, United States

Location

Delricht Clinical Research - Clinedge - Ppds Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02116, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

Great Lakes Research Group Inc

Bay City, Michigan, 48706, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

Minnesota Clinical Study Center

Minneapolis, Minnesota, 55432, United States

Location

Jdr Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

Suny Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Forest Hills Dermatology Group

Kew Gardens, New York, 11415, United States

Location

The Dermatology Specialists Greenwich

New York, New York, 10012, United States

Location

Icahn School of Medicine At Mount Sinai

New York, New York, 10029, United States

Location

Derm Research Center of New York Inc

Stony Brook, New York, 11790, United States

Location

Wake Research Associates Llc

Raleigh, North Carolina, 27612, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27104, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Kgl Skin Study Center

Broomall, Pennsylvania, 19008, United States

Location

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Palmetto Clinical Trial Services

Anderson, South Carolina, 29621, United States

Location

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, 37130, United States

Location

Innovative Dermatology

Plano, Texas, 75024, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

The Dermatology and Laser Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Clinical Research Partners Llc

Richmond, Virginia, 23226, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Medical Center Unimed Eood

Sevlievo, 05400, Bulgaria

Location

Diagnostic Consultative Center Ii Sofia Eood

Sofia, 01000, Bulgaria

Location

University Multiprofile Hospital For Active Treatment Aleksandrovska

Sofia, 01431, Bulgaria

Location

Diagnostic Consultative Center Xxviii - Sofia - Eood

Sofia, 01592, Bulgaria

Location

Medical Center Eurohealth

Sofia, 01606, Bulgaria

Location

Dermatology Research Institute

Calgary, Alberta, T1Y 0B4, Canada

Location

Simcoderm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1, Canada

Location

Kingsway Clinical Research

Etobicoke, Ontario, M8X 1Y9, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X2, Canada

Location

Skin Centre For Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Xlr8 Medical Research

Windsor, Ontario, N8W 1E6, Canada

Location

Siena Medical Research Corporation

Westmount, Quebec, H3Z 2S6, Canada

Location

Le Bateau Blanc

Martigues, 13500, France

Location

Hopital Archet 2 Derm Dept

Nice, 06200, France

Location

Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque

Pessac, 33604, France

Location

Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

Rouen, 76031, France

Location

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

Toulouse, 31059, France

Location

Universitaetsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Hautarztpraxis Mahlow

Mahlow, 15831, Germany

Location

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, 55131, Germany

Location

Universitatsklinik Munster Dermatologie

Münster, 48149, Germany

Location

Amsterdam University Medical Centre

Amsterdam, 1100 DD, Netherlands

Location

Synexus - Polska Sp Z Oo Oddzial W Gdansk

Gdansk, 80-382, Poland

Location

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

Gdynia, 81-537, Poland

Location

Synexus - Sp Z Oo Oddzial W Katowice

Katowice, 40-040, Poland

Location

Synexus Affiliate - Krakowskie Centrum Medyczne

Krakow, 31-501, Poland

Location

Synexus Polska Sp Z Oo Oddzial W Lodzi

Lodz, 90-127, Poland

Location

Synexus Polska Sp Z Oo Oddzial W Czestochowie

Lublin, 20-081, Poland

Location

Dermedic Dr. Zdybski

Ostrowiec Świętokrzyski, 27-400, Poland

Location

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

Poznan, 60-702, Poland

Location

Lubeskie Centrum Diagnostyczne

Świdnik, 21-040, Poland

Location

Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz

Torun, 87-100, Poland

Location

Synexus Polska Sp. Z O.O. Oddzial Warszawie

Warsaw, 01-192, Poland

Location

High-Med Przychodnia Specjalistycza

Warsaw, 01-817, Poland

Location

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

Wroclaw, 50-381, Poland

Location

Dermmedica Sp. Z O.O.

Wroclaw, 51-318, Poland

Location

Ico Hospital Germans Trias I Pujol

Badalona, 08916, Spain

Location

Dermomedic

Madrid, 28001, Spain

Location

Clinica Universidad de Navarra (Cun)

Pamplona, 31008, Spain

Location

Related Publications (1)

• Rosmarin D, Pandya AG, Passeron T, Forman SB, Zdybski J, Amster M, Feser C, Papp KA, Nuara A, Kornacki D, Wei S, Ren H, Harris JE, Ezzedine K. Long-Term Integrated Safety Summary of Ruxolitinib Cream in Phase 3 Clinical Trials of Patients with Vitiligo. Dermatol Ther (Heidelb). 2025 Dec;15(12):3703-3716. doi: 10.1007/s13555-025-01555-3. Epub 2025 Oct 22.

  PMID: 41125994 DERIVED

MeSH Terms

Conditions

Vitiligo

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Data from participants at a single site (N = 2) were removed from all efficacy analyses performed on the ITT-Ext Population and FAS Cohort A owing to noncompliance with the Protocol in the parent study resulting in serious concerns with data quality.

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Kathleen Butler, MD

  Incyte Corporation

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: September 24, 2020
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: August 14, 2025
• Results First Posted: July 19, 2023

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

CA (8); US (44); DE (4); BU (5); FR (5); ES (3); NL (1); PL (14)