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

• Status: Not yet recruiting
• Trial end date: 2023-12-29
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

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.