A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Intervention: Ruxolitinib cream; Vehicle cream
Intervention description: Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.; Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking description: Double Blind
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Vitiligo; depigmenting disorder; topical JAK inhibitor

Summary:

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

Eligibility 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.