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A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

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ClinicalTrials.gov Identifier: NCT03099304
Recruitment Status : Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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

Condition or disease Intervention/treatment Phase
Vitiligo Drug: Ruxolitinib cream Drug: Vehicle cream Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Dose-Ranging Study of INCB018424 Phosphate Cream in Subjects With Vitiligo
Actual Study Start Date : April 19, 2017
Actual Primary Completion Date : September 12, 2018
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Arms and Interventions
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Arm Intervention/treatment
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 52-week open-label extension.
 Drug: Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Other Name: INCB018424 cream
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 52-week open-label extension.
 Drug: Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Other Name: INCB018424 cream

Drug: Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
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 52-week open-label extension.
 Drug: Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Other Name: INCB018424 cream

Drug: Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
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 52-week open-label extension.
 Drug: Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Other Name: INCB018424 cream

Drug: Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
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 52-week open-label extension.
 Drug: Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Other Name: INCB018424 cream

Drug: Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of vitiligo.

  • Vitiligo with depigmented areas including:

    • at least 0.5% of the total body surface area (BSA) on the face (0.5% BSA is approximately equal to the area of the participant's palm [without digits]) AND
    • at least 3% of the total BSA on nonfacial areas (3% BSA is approximately equal to the area of 3 of the participant's handprints [palm plus 5 digits]).
  • Participants who agree to discontinue all agents used to treat vitiligo from screening through the final follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.

Exclusion Criteria:

  • Conditions at baseline that would interfere with evaluation of vitiligo.
  • Participants who are receiving any kind of phototherapy, including tanning beds.
  • Participants with other dermatologic disease besides vitiligo whose presence or treatments could complicate the assessment of repigmentation.
  • Participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.

  • Participants who have received any of the following treatments within the minimum specified timeframes.

    • Use of any biologic, investigational, or experimental therapy or procedure for vitiligo within 12 weeks or 5 half-lives (whichever is longer) of screening.
    • Use of laser or light-based vitiligo treatments, including tanning beds, within 8 weeks of screening.
    • Use of immunomodulating oral or systemic medications (eg, corticosteroids, methotrexate, cyclosporine) or topical treatments that may affect vitiligo (eg, corticosteroids, tacrolimus/pimecrolimus, retinoids) within 4 weeks of screening.
  • Use of any prior and concomitant therapy not listed above that may interfere with the objective of the study as per discretion of the investigator, including drugs that cause photosensitivity or skin pigmentation (eg, antibiotics such as tetracyclines, antifungals) within 8 weeks of screening.
  • Participants with a clinically significant abnormal thyroid-stimulating hormone or free T4 at screening.
  • Participants with protocol-defined cytopenias at screening
  • Participants with severely impaired liver function.
  • Participants with impaired renal function.
  • Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit.
  • Participants who have previously received JAK inhibitor therapy, systemic or topical.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099304


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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Kathleen Butler, MD Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03099304     History of Changes
Other Study ID Numbers: INCB 18424-211
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Vitiligo
depigmenting disorder
topical JAK inhibitor
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases