The SUN AS012 trial is currently in Phase 2 and is a randomized, double-blinded, vehicle-controlled, dose-ranging, 64-week study evaluating the safety and efficacy of AS012 in patients with generalized, non-segmental vitiligo.

Total participation time includes a 3-week screening period, a 52-week treatment period including a 24-week placebo-controlled period
and a 12-week follow-up period.

  • During the first 24-week placebo-controlled period, subjects have an 80% chance of receiving the investigational product at
    varying doses.
  • After 24 weeks, all participants, including those who were originally randomized to the placebo arm, will receive the investigational

Inclusion Criteria

  • 18 years of age or older
  • Males and non-pregnant, non-lactating females
  • Willingness to use reliable form of contraception
  • Generalized, non-segmental vitiligo with:
    Body surface area >5% but <30% (1% = 1 closed palm print) AND
    Facial involvement of at least 0.3% (1/3 palm print or 3 thumb prints)
  • Willingness to refrain from all study-prohibited medications during treatment period

Exclusion Criteria

  • Female subjects who are pregnant, nursing or planning to become pregnant during study participation or within 3 months of completing the study
  • Segmental, focal or mixed vitiligo
  • Active / unstable vitiligo is NOT an exclusion
  • Patches of de-pigmented (white) hair in over 50% of the skin surface affected by the vitiligo
  • Subjects who are at high risk of suicidality
  • Current, or within the past year, history of severe, progressive, or uncontrolled renal, hepatic, hematologic, GI or metabolic, endocrine, pulmonary, cardiovascular or neurological disease
  • Adequate wash-out period of study-prohibited medications:
    Topical or oral immunomodulators (corticosteroids, calcineurin inhibitors) for 15 and 30 days, respectively
    Narrowband UVB (including excimer) for 60 days
    Minocycline for 15 days
    Methotrexate for 30 days
    Topical and oral JAK inhibitors for 90 days
    Polypodium leucotomas for 15 days
    Live vaccines (including COVID-19 vaccine) for 30 days

For questions and participant referrals, including self-referrals, contact or call 425-275-4404.

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