A Double-Blind, Vehicle-Controlled, Randomized Withdrawal and Treatment Extension Study to Assess the Long-Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

Phase 3

Conditions: leucoderma
white patches of skin
10040790

Registration Number: NL-OMON51116

Lead Sponsor: Incyte Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Currently enrolled and receiving treatment in INCB 18424-306 or INCB
18424-307 studies evaluating ruxolitinib cream in participants with vitiligo.
2. Currently tolerating ruxolitinib cream in the parent study and no safety
concerns per investigators judgment.
3. Has demonstrated compliance, as assessed by the investigator, with the
parent study protocol requirements

Exclusion Criteria

1. Has been permanently discontinued from study treatment in the parent study
for any reason.
2. 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. 3. Pregnant or breastfeeding
woman

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For participants who are randomized in Cohort A: * Time to relapse (defined as<br /><br>< F-VASI75)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>For participants who are randomized in Cohort A: * Time to maintain * F-VASI90<br /><br>response<br /><br><br /><br>and:<br /><br>* Proportion of participants who achieve F-VASI50/75/90 during the extension<br /><br>treatment period.<br /><br>* Actual measurements, change, and percentage change from baseline in F-VASI.<br /><br>* Proportion of participants who achieve T-VASI50/75/90 during the extension<br /><br>treatment period.<br /><br>* Actual measurements, change, and percentage change from baseline in T-VASI.<br /><br>* Actual measurements, change, and percentage change from baseline in F-BSA.<br /><br>* Actual measurements, change, and percentage change from baseline in T-BSA.<br /><br>* Proportion of participants achieving a VNS of 4 A lot less noticeable* or<br /><br>5 No longer noticeable* during the extension treatment period</p><br>