Vitiligo
A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo
Incyte Study ID:
INCB 18424-211
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Results Available
Protocol
Available Languages: English
Statistical Analysis Plan (SAP)
Available Languages: English
Clinical Study Purpose
The purpose of this study will be to examine the efficacy, safety, and tolerability of ruxolitinib cream in subjects with vitiligo.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Jun 2017 - Sep 2018
TYPE
Interventional
PHASE
Phase 2
SEX
Female & Male
AGE
18 - 75 Years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Name
Contact UsName
UNIVERSITY OF ALABAMA AT BIRMINGHAM (UAB), 1802 6th Ave S
Birmingham, Alabama, US, 35233
Name
BURKE PHARMACEUTICAL RESEARCH LLC, 3633 Central Ave
Hot Springs, Arkansas, US, 71913
Name
NORTHWEST AR CLINICAL TRIALS CENTER, PLLC/HULL DERMATOLOGY, PA, 500 S 52nd Street
Rogers, Arkansas, US, 72758
Name
THE VITILIGO & PIGMENTATION INSTITUE OF SOUTHERN CALIFORNIA, 5670 Wilshire Boulevard
Los Angeles, California, US, 90036
Name
DERMATOLOGY RESEARCH ASSOCIATES- LOS ANGELES, 8930 S Sepulveda Blvd
Los Angeles, California, US, 90045
Name
DERMATOLOGY SPECIALISTS, 3629 Vista Way
Oceanside, California, US, 92056
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Clinical diagnosis of vitiligo.
- Vitiligo with depigmented areas including:
Exclusion Criteria
- Conditions at baseline that would interfere with evaluation of vitiligo.
- Participants who are receiving any kind of phototherapy, including tanning beds.
Protocol Summary
Incyte Study ID:
INCB 18424-211
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Interventions:
Drug
Enrollment:
157
Primary Outcome
Open
Percentage of participants treated with ruxolitinib cream who achieve a ≥ 50% improvement in facial assessment of the Vitiligo Area and Severity Index score (F-VASI50) compared with participants treated with vehicle
Timeframe: Week 24
Secondary Outcome
Open
Percentage of participants who achieve a facial assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of clear or almost clear
Timeframe: Week 24
Percentage of participants who achieve a ≥ 50% improvement from baseline in full body assessment of Vitiligo Area and Severity Index (T-VASI)
Timeframe: Week 52
Safety and tolerability assessed by monitoring the frequency, duration, and severity of adverse events (AEs)
Timeframe: Screening through at least 30 days after the last dose of study drug, up to 120 weeks per participant
Dose response on Percentage Change from baseline in F-VASI
Timeframe:
Mean and percentage change from baseline in F-VASI score during the treatment periods.
Timeframe:
Percentage of subjects who achieve an F-VASI50
Timeframe:
Percentage Change from baseline in F-BSA repigmentation
Timeframe:
Percentage of Subjects in each F-PaGVA adn T-PaGVA category
Timeframe:
Mean and percentage change from baseline in T-VASI score
Timeframe:
Mean and Percentage change from baseline in VETF
Timeframe:
Percentage of subjects in each F-PhGVA and T-PhGVA category during the treatment periods
Timeframe:
Percentage of subjects in each F-PaGVA and T-PaGVA category during the treatment periods
Timeframe:
Percentage of subjects in each PaGIC-V category during the treatment periods
Timeframe:
Proportion of subjects who report PaGIC-V of very much improved or much improved
Timeframe:
Times to achieve an F-VASI50 and T-VASI50
Timeframe:
Times to achieve an F-PhGVA and T-PhGVA of clear or almost clear
Timeframe:
Time to achieve a PaGIC-V of very much improved or much improved
Timeframe: