Clinical Trial: A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Dose-Ranging Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

Brief Summary: The purpose of this study is to examine the efficacy, safety, and tolerability of INCB018424 cream in subjects with vitiligo.

Detailed Summary:
Sponsor: Incyte Corporation

Current Primary Outcome: Percentage of participants treated with INCB018424 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 [ Time Frame: Week 24 ]

F-VASI is the percentage of depigmented vitiligo skin expressed as a percentage of the total area of skin on the face (100%) and estimated by the investigator using the palmar method.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of participants who achieve a facial assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of clear or almost clear [ Time Frame: Week 24 ]
    F-PhGVA has a 5-point scale (clear, almost clear, mild disease, moderate disease, and severe disease) assessed by the physician to determine the severity of vitiligo and will be reported for face and overall. Complete facial repigmentation is defined as an F-PhGVA of clear (0).
  • Percentage of participants who achieve a ≥ 50% improvement from baseline in full body assessment of Vitiligo Area and Severity Index (T-VASI) [ Time Frame: Week 52 ]
    T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
  • Safety and tolerability assessed by monitoring the frequency, duration, and severity of adverse events (AEs) [ Time Frame: Screening through at least 30 days after the last dose of study drug, up to 120 weeks per participant ]
    AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related, that occurs after a subject provides informed consent. Abnormal laboratory values or test results occurring after informed consent constitute AEs only if they induce clinical signs or symptoms, are considered clinically meaningful, require therapy, or require changes in the study drug.


Original Secondary Outcome: Same as current

Information By: Incyte Corporation

Dates:
Date Received: March 28, 2017
Date Started: April 19, 2017
Date Completion: May 2020
Last Updated: May 8, 2017
Last Verified: May 2017