Vitiligo MedDRA version: 21.1 Level: PT Classification code 10047642 Term: Vitiligo System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the duration of clinical response of ruxolitinib cream in participants with vitiligo.;Secondary Objective: Key secondary: To evaluate the duration of clinical response of ruxolitinib cream in participants with vitiligo. Secondary: To further evaluate the efficacy of ruxolitinib cream. To determine the participants' quality of life. To evaluate the safety and tolerability of ruxolitinib cream. To evaluate the ruxolitinib PK in plasma after treatment with ruxolitinib cream.;Primary end point(s): For participants who are randomized in Cohort A: • Time to relapse (defined as < F-VASI75).;Timepoint(s) of evaluation of this end point: over 52 week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary: For participants who are randomized in Cohort A: • Time to maintain = F-VASI90 response. Secondary: • Proportion of participants who achieve F-VASI50/75/90 during the extension treatment period. • Actual measurements, change, and percentage change from baseline in F-VASI. • Proportion of participants who achieve T-VASI50/75/90 during the extension treatment period. • Actual measurements, change, and percentage change from baseline in T-VASI. • Actual measurements, change, and percentage change from baseline in F-BSA. • Actual measurements, change, and percentage change from baseline in T-BSA. • Proportion of participants achieving a VNS of “4 – A lot less noticeable” or “5 – No longer noticeable” during the extension treatment period. •Change from Week 52 in DLQI (or CDLQI) during the extension treatment period. • The frequency and severity of AEs; includes performing physical examinations and collecting vital signs and laboratory data for hematology and serum chemistry. •Trough plasma concentrations of ruxolitinib at Week 80 and Week 104.;Timepoint(s) of evaluation of this end point: over 52 week treatment period | — |
Countries
Bulgaria, Canada, France, Germany, Italy, Netherlands, Poland, Spain, United States
Contacts
Public ContactClinical Trials Information
Incyte Corporation
Outcome results
None listed