Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

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

Keywords

Lichen Sclerosus, Skin Diseases, 18424, Ruxolitinib, topical cream, vulvar disease, Lichen Sclerosus et Atrophicus, Ruxolitinib cream, Vehicle cream

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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.

You CAN'T join if...

  • Participants who do not have LS involving anogenital area.
  • Concurrent conditions and history of other diseases:
  • 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.
  • Have active genital/vulvar lesions at screening and Day 1, not related to LS
  • 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.

Locations

  • UC Irvine not yet accepting patients
    Irvine California 92697 United States
  • Cahaba Dermatology accepting new patients
    Birmingham Alabama 35244 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT05593445
Phase
Phase 2 Lichen Sclerosus Research Study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated