A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

Conditions

• Vitiligo

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib cream — DRUG
  Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
• Vehicle cream — DRUG
  Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Study Details

The purpose of this study will be to examine the efficacy, safety, and tolerability of ruxolitinib cream in subjects with vitiligo.

Key Dates

Start date

Jun 7, 2017

Status verified

Oct 2022

Primary completion

Sep 12, 2018

Completion

Sep 8, 2021

Study Design

Enrollment

157 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Ruxolitinib cream 1.5% twice daily (BID)
  Ruxolitinib cream 1.5% BID for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
• Experimental: Ruxolitinib cream 1.5% once daily (QD)
  Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
• Experimental: Ruxolitinib cream 0.5% QD
  Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
• Experimental: Ruxolitinib cream 0.15% QD
  Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 52 weeks (opportunity for re-randomization to a higher dose at Week 24 if \< 25% improvement in F-VASI score), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
• Placebo Comparator: Vehicle BID
  Vehicle cream BID for 24 weeks, followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% QD, or 0.5% QD for Weeks 24 to 52, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.

Primary Outcome Measure

Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24 [ Time Frame: Baseline; Week 24 ]

Locations (26)

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