Primary Outcome
Open
Cohort A : Time to Relapse
Timeframe: Extension period through Week 108
Vitiligo
Assess the long term efficacy and safety of Ruxolitinib cream in participants with Vitiligo
Incyte Study ID:
INCB 18424-308
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Study Complete
Clinical Study Purpose
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.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Sep 2020 - Nov 2022
TYPE
Interventional
PHASE
Phase 3
SEX
Female & Male
AGE
12+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Key Inclusion and Exclusion Criteria
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.
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.
Clinical Study Locations
Location
Status
Location
FORCARE CLINICAL RESEARCH FCR FORWARD CLINICAL TRIALS, INC
TAMPA, FL, US, 33624
Status
Active, not recruiting
Location
MARVEL CLINICAL RESEARCH LLC
HUNTINGTON BEACH, CA, US, 92647
Status
Active, not recruiting
Location
DESERT SKY DERMATOLOGY
GILBERT, AZ, US, 85295
Status
Active, not recruiting
Location
SAN MARCUS RESEARCH CLINIC INC.
MIAMI LAKES, FL, US, 33014
Status
Active, not recruiting
Location
INTERNATIONAL CLINICAL RESEARCH TENNESSEE LLC
MURFREESBORO, TN, US, 37130
Status
Active, not recruiting
Location
WAKE RESEARCH ASSOCIATES LLC
RALEIGH, NC, US, 27612
Status
Active, not recruiting
Protocol Summary
Incyte Study ID:
INCB 18424-308
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Interventions:
Drug
Enrollment:
458
Secondary Outcome
Open
Cohort A : Time to maintain ≥ F-VASI90 response
Timeframe: Extension period through Week 108
Proportion of participants achieving F-VASI50
Timeframe: Extension period through Week 108
Proportion of participants achieving F-VASI75
Timeframe: Extension period through Week 108
Proportion of participants achieving F-VASI90
Timeframe: Extension period through Week 108
Proportion of participants achieving T-VASI50
Timeframe: Extension period through Week 108
Proportion of participants achieving T-VASI75
Timeframe: Extension period through Week 108
Proportion of participants achieving T-VASI90
Timeframe: Extension period through Week 108
Actual Measurement of F-VASI
Timeframe: Baseline through Week 108
Change in F-VASI
Timeframe: Baseline through Week 108
Percentage Change in F-VASI
Timeframe: Baseline through Week 108
Actual Measurement of T-VASI
Timeframe: Baseline through Week 108
Change in T-VASI
Timeframe: Baseline through Week 108
Percentage Change in T-VASI
Timeframe: Baseline through Week 108
Actual Measurement of T-BSA
Timeframe: Baseline through Week 108
Change in T-BSA
Timeframe: Baseline through Week 108
Percentage Change in T-BSA
Timeframe: Baseline through Week 108
Actual Measurement of F-BSA
Timeframe: Baseline through Week 108
Change in F-BSA
Timeframe: Baseline through Week 108
Percentage Change in F-BSA
Timeframe: Baseline through Week 108
Proportion of participants achieving a VNS of 4 or 5
Timeframe: Extension period through Week 108