ong-Term Efficacy and Safety Study of Ruxolitinib Cream in Participants With Vitiligo

Phase 1

• Conditions: Vitiligo; MedDRA version: 21.1Level: PTClassification code 10047642Term: VitiligoSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-000987-53-DE
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-17
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 500

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.
4. Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.
5. Male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of the following:
a. Females of non-childbearing potential (ie, or surgically sterile with a hysterectomy and/or bilateral oophorectomy OR postmenopausal, = 12 months of amenorrhea without an alternative medical cause).
b. Prepubescent adolescents (age 12-18 years old at the time enrolled in parent studies).
6. For adult participant, ability to comprehend and willingness to sign an ICF; for adolescent participant, written informed consent of the parent(s) or legal guardian and written assent from the adolescent participant when possible.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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.
4. Participants who live with anyone participating in any current Incyte-sponsored ruxolitinib cream study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the duration of clinical response of ruxolitinib cream in participants with vitiligo.;Secondary Objective: Key secondary:<br>To evaluate the duration of clinical response of ruxolitinib cream in participants with vitiligo.<br>Secondary:<br>To further evaluate the efficacy of ruxolitinib cream.<br>To determine the participants' quality of life.<br>To evaluate the safety and tolerability of ruxolitinib cream.<br>To evaluate the ruxolitinib PK in plasma after treatment with ruxolitinib cream.;Primary end point(s): For participants who are randomized in Cohort A:<br>• Time to relapse (defined as < F-VASI75).;Timepoint(s) of evaluation of this end point: over 52 week treatment period