Topical Ruxolitinib for the Treatment of Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Intervention: Ruxolitinib 1.5% Phosphate Cream
Intervention description: twice daily topical application of Ruxolitinib 1.5% Phosphate Cream beginning at baseline and ending at week 20
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if topical ruxolitinib 1.5% will provide
      repigmentation in vitiligo lesions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of vitiligo.

          -  At Visit 1 (Baseline/Day 1), have had vitiligo covering at least 1% of total body
             surface area (BSA) on the scalp, trunk or limbs (excluding nails).

          -  Female subjects of childbearing potential must agree to use a highly effective method
             of contraception throughout the study and for at least four weeks after the last dose
             of assigned treatment. Male subjects must also use contraception, such as barrier
             method with spermicide.

          -  If receiving concomitant medications for any reason, must be on a stable regimen and
             willing to stay on a stable regimen.

          -  Must be willing to washout of other vitiligo treatments. All treatments for vitiligo
             are prohibited during the course of the study.

        Exclusion Criteria:

          -  Other skin conditions at Baseline that would interfere with evaluation of vitiligo.

          -  Pregnant/breastfeeding females, or females of childbearing potential not using highly
             effective contraception. Women of childbearing potential must test negative for
             pregnancy and use contraception for at least four weeks after last dose of drug.

          -  Current or recent history of clinically significant medical/psychiatric condition or
             laboratory abnormality that may increase risk associated with the study participation
             or drug administration.

          -  Have a history of any lymphoproliferative disorder, lymphoma, leukemia, history of
             disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized,
             dermatomal herpes zoster.

          -  Have a history of infection requiring parenteral or oral or topical antimicrobial
             therapy within 2 weeks prior to Baseline.

          -  Vaccinated with live/attenuated live vaccine within 6 weeks prior to Baseline.

          -  Previously participated in study of oral/topical ruxolitinib or tofacitinib
             (tofacitinib, CP-690,550, formerly tasocitinib) unless confirmed to have been
             randomized to and treated with placebo or placebo topical formulation (vehicle) only.

          -  Received a prohibited concomitant medication within 7 days or 5 half-lives (whichever
             is longer) prior to Baseline.

          -  Have participated in other studies within 4 weeks or 5 half-lives (whichever is
             longer) prior to Visit 1 (Baseline/Day 1). Subjects cannot participate in studies of
             other investigational or experimental therapies or procedures at any time during their
             participation in this study.

          -  Subjects who are investigational site staff members or relatives of those site staff
             members or subjects who are Sponsor employees directly involved in the conduct of the
             trial.

          -  In the opinion of the investigator or Sponsor, the subject is inappropriate for entry
             into this study, or unwilling/unable to comply with study procedures and lifestyle
             guidelines.

          -  Screening laboratory abnormalities

          -  CYP Inhibitor Exclusion: Subjects taking potent CYP3A4 inhibitors or fluconazole
             within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit.