A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

Completed · Phase 2

Conditions studied: Vitiligo

In brief

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

Key facts

Study ID

NCT03099304

Run by

Incyte Corporation

People needed

157

Starts

2017-06-07

Expected to finish

2021-09-08

Last updated by the study team

2022-11-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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