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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

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

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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

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.




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.



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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.

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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Locations
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United States, Alabama
UNIVERSITY OF ALABAMA AT BIRMINGHAM (UAB), 1802 6th Ave S
Birmingham, Alabama, United States, 35233
United States, Arkansas
BURKE PHARMACEUTICAL RESEARCH LLC, 3633 Central Ave
Hot Springs, Arkansas, United States, 71913
NORTHWEST AR CLINICAL TRIALS CENTER, PLLC/HULL DERMATOLOGY, PA, 500 S 52nd Street
Rogers, Arkansas, United States, 72758
United States, California
THE VITILIGO & PIGMENTATION INSTITUE OF SOUTHERN CALIFORNIA, 5670 Wilshire Boulevard
Los Angeles, California, United States, 90036
DERMATOLOGY RESEARCH ASSOCIATES- LOS ANGELES, 8930 S Sepulveda Blvd
Los Angeles, California, United States, 90045
DERMATOLOGY SPECIALISTS, 3629 Vista Way
Oceanside, California, United States, 92056
United States, Connecticut
CLINICAL RESEARCH CENTER OF CT, 27 Hospital Avenue
Danbury, Connecticut, United States, 06810
United States, Florida
LEAVITT MEDICAL ASSOCIATES OF FLORIDA INC/ AMERIDERM RESEARCH, 725 W Granada Blvd
Ormond Beach, Florida, United States, 32174
United States, Georgia
EMORY UNIVERSITY, 1525 Clifton Road
Atlanta, Georgia, United States, 30322
United States, Illinois
NORTHWESTERN UNIVERSITY, 676 N Saint Clair
Chicago, Illinois, United States, 60611
United States, Indiana
DAWES FRETZIN CLINICAL RESEARCH GROUP, 8103 Clearvista Parkway
Indianapolis, Indiana, United States, 46256
DS RESEARCH, 2241 Green Valley Road
New Albany, Indiana, United States, 47150
United States, Louisiana
TULANE UNIVERSITY, 1415 Tulane Avenue
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Tufts Medical Center, 260 Tremont Street
Boston, Massachusetts, United States, 02111
UNIVERSITY OF MASSACHUESETTS, 364 Plantation Street
Worcester, Massachusetts, United States, 01605
United States, Michigan
HAMZAVI DERMATOLOGY, 3031 W Grand Blvd
Detroit, Michigan, United States, 48059
United States, Missouri
WASHINGTON UNIVERSITY SCHOOL OF MEDICINE DERMATOLOGY, 969 N. Mason Road
Saint Louis, Missouri, United States, 63141
United States, New Hampshire
ACTIVMED PRACTICES & RESEARCH, INC, 110 Corporate Drive
Portsmouth, New Hampshire, United States, 03801
United States, New York
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI MEDICAL CENTER- DERMATOLOGY ASSOCIATES, 5 E 98th Street
New York, New York, United States, 11209
United States, North Carolina
WAKE FOREST UNIVERSITY HEALTH SCIENCES, Medical Center Boulevard
Winston-Salem, North Carolina, United States, 27157
United States, Oklahoma
CENTRAL SOONER RESEARCH, 900 N Porter Ave
Norman, Oklahoma, United States, 73071
United States, Rhode Island
RHODE ISLAND HOSPITAL, 593 Eddy Street
Providence, Rhode Island, United States, 02903
United States, Texas
ARLINGTON RESEARCH CENTER, INC., 711 East Lamar Boulevard
Arlington, Texas, United States, 76011
MENTER DERMATOLOGY RESEARCH INSTITUTE, 3900 Junius Street
Dallas, Texas, United States, 75246
UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER, DEPARTMENT OF DERMATOLOGY, 5323 Harry Hines Blvd
Dallas, Texas, United States, 75390
THE DERMATOLOGY AND LASER CENTER OF SAN ANTONIO, 7810 Louis Pasteur
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Kathleen Butler, MD Incyte Corporation

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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