Last updated on January 2018

A Randomized, Double-Blind, Dose-Ranging Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Vitiligo
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Male or female subjects aged 18 to 75 years, inclusive.
  • Subjects with a clinical diagnosis of vitiligo.
  • Subjects with vitiligo with depigmented areas including:
  • at least 0.5% of the total BSA on the face (0.5% BSA is approximately equal to the area of the subject'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 subject's handprints [palm plus 5 digits]).
  • Subjects who agree to discontinue all agents used to treat vitiligo from screening through the final follow-up visit. Exclusion Criteria:
  • Conditions at baseline that would interfere with evaluation of vitiligo.
  • Subjects who are receiving any kind of phototherapy, including tanning beds.
  • Subjects with other dermatologic disease besides vitiligo whose presence or treatments could complicate the assessment of repigmentation.
  • Subjects who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.
  • Subjects 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. Investigational biologics should be discussed with the sponsor to determine if a longer period of discontinuation is required.
  • 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 within 4 weeks of screening.
  • Subjects with a clinically significant abnormal TSH or free T4 at screening as determined by the investigator.
  • Subjects with cytopenias at screening.
  • Subjects with severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase or aspartate aminotransferase ≥ 1.5 × upper limit of normal on repeated assessment.
  • Subjects with impaired renal function with estimated creatinine clearance less than 60 mL/min.
  • Positive serology test results for HIV, for hepatitis B surface antigen or core antibody, or for hepatitis C virus antibody with detectable RNA at screening.
  • Subjects taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit.
  • Subjects who have previously received JAK inhibitor therapy, systemic or topical.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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