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

Completed · Phase 3

Conditions studied: Vitiligo

In brief

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.

Key facts

Study ID

NCT04530344

Run by

Incyte Corporation

People needed

458

Starts

2020-09-24

Expected to finish

2022-11-14

Last updated by the study team

2025-08-14

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Desert Sky Dermatology — Gilbert, Arizona, United States
• First Oc Dermatology — Fountain Valley, California, United States
• Center For Dermatology Cosmetic and Laser Surgery — Fremont, California, United States
• Marvel Clinical Research Llc — Huntington Beach, California, United States
• Vitiligo & Pigmentation Institute of Southern California — Los Angeles, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Acrc Studies — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• Colorado Medical Research Center Inc — Denver, Colorado, United States
• Harmony Medical Research Institute — Hialeah, Florida, United States
• Advanced Pharma — Miami, Florida, United States
• San Marcus Research Clinic Inc. — Miami Lakes, Florida, United States
• Leavitt Medical Associates of Florida — Ormond Beach, Florida, United States
• Avita Clinical Research — Tampa, Florida, United States
• Olympian Clinical Research — Tampa, Florida, United States
• Forcare Clinical Research Fcr Forward Clinical Trials, Inc — Tampa, Florida, United States
• Metabolic Research Institute Inc — West Palm Beach, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Randall Dermatology — West Lafayette, Indiana, United States
• Delricht Clinical Research - Clinedge - Ppds Baton Rouge — Baton Rouge, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Metro Boston Clinical Partners — Brighton, Massachusetts, United States
• Great Lakes Research Group Inc — Bay City, Michigan, United States
• Henry Ford Medical Center — Detroit, Michigan, United States
• Cahaba Dermatology — Hoover, Alabama, United States

Full record on ClinicalTrials.gov

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