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

  • STATUS
    Recruiting
  • End date
    Jan 18, 2024
  • participants needed
    500
  • sponsor
    Incyte Corporation
Updated on 4 July 2021

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.

Details
Condition Vitiligo
Treatment Ruxolitinib, Vehicle
Clinical Study IdentifierNCT04530344
SponsorIncyte Corporation
Last Modified on4 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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