A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus

A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus

The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 12 weeks followed by an open label period (OLE) period of 12 weeks.

Inclusion Criteria:

• Biopsy-proven LS in the anogenital area.
• Baseline IGA score ≥ 2 for LS.
• Baseline Itch NRS score ≥ 4 in anogenital area.
• Willingness to avoid pregnancy.

Exclusion Criteria:

• Participants who do not have LS involving anogenital area.

• Concurrent conditions and history of other diseases:

  1. Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including: candidiasis, chlamydia trachomatis, trichomonas vaginalis, neisseria gonorrhoeae, bacterial vaginosis, or herpes simplex.
  2. Have active genital/vulvar lesions at screening and Day 1, not related to LS
  3. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.

• Laboratory values outside of the protocol-defined criteria

• Pregnant or lactating participants or those considering pregnancy during the period of their study participation..

• Other exclusion criteria may apply.