A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo
NCT ID: NCT03099304
Last Updated: 2022-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
157 participants
INTERVENTIONAL
2017-06-07
2021-09-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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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.
Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
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.
Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
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.
Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
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.
Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
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.
Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Interventions
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Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Kathleen Butler, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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UNIVERSITY OF ALABAMA AT BIRMINGHAM (UAB), 1802 6th Ave S
Birmingham, Alabama, United States
BURKE PHARMACEUTICAL RESEARCH LLC, 3633 Central Ave
Hot Springs, Arkansas, United States
NORTHWEST AR CLINICAL TRIALS CENTER, PLLC/HULL DERMATOLOGY, PA, 500 S 52nd Street
Rogers, Arkansas, United States
THE VITILIGO & PIGMENTATION INSTITUE OF SOUTHERN CALIFORNIA, 5670 Wilshire Boulevard
Los Angeles, California, United States
DERMATOLOGY RESEARCH ASSOCIATES- LOS ANGELES, 8930 S Sepulveda Blvd
Los Angeles, California, United States
DERMATOLOGY SPECIALISTS, 3629 Vista Way
Oceanside, California, United States
CLINICAL RESEARCH CENTER OF CT, 27 Hospital Avenue
Danbury, Connecticut, United States
LEAVITT MEDICAL ASSOCIATES OF FLORIDA INC/ AMERIDERM RESEARCH, 725 W Granada Blvd
Ormond Beach, Florida, United States
EMORY UNIVERSITY, 1525 Clifton Road
Atlanta, Georgia, United States
NORTHWESTERN UNIVERSITY, 676 N Saint Clair
Chicago, Illinois, United States
DAWES FRETZIN CLINICAL RESEARCH GROUP, 8103 Clearvista Parkway
Indianapolis, Indiana, United States
DS RESEARCH, 2241 Green Valley Road
New Albany, Indiana, United States
TULANE UNIVERSITY, 1415 Tulane Avenue
New Orleans, Louisiana, United States
Tufts Medical Center, 260 Tremont Street
Boston, Massachusetts, United States
UNIVERSITY OF MASSACHUESETTS, 364 Plantation Street
Worcester, Massachusetts, United States
HAMZAVI DERMATOLOGY, 3031 W Grand Blvd
Detroit, Michigan, United States
WASHINGTON UNIVERSITY SCHOOL OF MEDICINE DERMATOLOGY, 969 N. Mason Road
St Louis, Missouri, United States
ACTIVMED PRACTICES & RESEARCH, INC, 110 Corporate Drive
Portsmouth, New Hampshire, United States
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI MEDICAL CENTER- DERMATOLOGY ASSOCIATES, 5 E 98th Street
New York, New York, United States
WAKE FOREST UNIVERSITY HEALTH SCIENCES, Medical Center Boulevard
Winston-Salem, North Carolina, United States
CENTRAL SOONER RESEARCH, 900 N Porter Ave
Norman, Oklahoma, United States
RHODE ISLAND HOSPITAL, 593 Eddy Street
Providence, Rhode Island, United States
ARLINGTON RESEARCH CENTER, INC., 711 East Lamar Boulevard
Arlington, Texas, United States
MENTER DERMATOLOGY RESEARCH INSTITUTE, 3900 Junius Street
Dallas, Texas, United States
UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER, DEPARTMENT OF DERMATOLOGY, 5323 Harry Hines Blvd
Dallas, Texas, United States
THE DERMATOLOGY AND LASER CENTER OF SAN ANTONIO, 7810 Louis Pasteur
San Antonio, Texas, United States
Countries
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References
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Howell MD, Kuo FI, Rumberger B, Boarder E, Sun K, Butler K, Harris JE, Grimes P, Rosmarin D. Baseline Levels of Circulating Inflammatory Biomarkers Stratify Patients with Vitiligo Who Significantly Repigment after Treatment with Ruxolitinib Cream. JID Innov. 2023 Sep 13;3(6):100230. doi: 10.1016/j.xjidi.2023.100230. eCollection 2023 Nov.
Rosmarin D, Pandya AG, Lebwohl M, Grimes P, Hamzavi I, Gottlieb AB, Butler K, Kuo F, Sun K, Ji T, Howell MD, Harris JE. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet. 2020 Jul 11;396(10244):110-120. doi: 10.1016/S0140-6736(20)30609-7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INCB 18424-211
Identifier Type: -
Identifier Source: org_study_id
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