Overview

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.