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

Lichen Sclerosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05593445
• Other study ID #: INCB 18424-220
• Status: Completed
• Phase: Phase 2
• Start date: November 18, 2022
• Est. completion date: December 21, 2023

Study information

• Verified date: January 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 21, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lichen Sclerosus
• Lichen Sclerosus et Atrophicus

Intervention

Drug:
• Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
• Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Locations

Country	Name	City	State
Canada	Clinique Rsf	Quebec
Canada	K. Papp Clinical Research	Waterloo	Ontario
United States	Apex Dermatology	Ashtabula	Ohio
United States	Bexley Dermatology	Bexley	Ohio
United States	Cahaba Dermatology	Birmingham	Alabama
United States	Unc Dermatology and Skin Cancer Center At Southern Village	Chapel Hill	North Carolina
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	UC Irvine	Irvine	California
United States	New Age Medical Research Corporation	Miami	Florida
United States	University of Utah Health Care Midvalley Health Center Dermatology	Murray	Utah
United States	Mayo Clinic - Scottsdale	Scottsdale	Arizona
United States	Seattle Skin and Laser Clinic	Seattle	Washington
United States	The Centers For Vulvovaginal Disorders	Washington	District of Columbia
United States	Circuit Clinical	West Seneca	New York

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with ITCH4	ITCH4 response defined as a = 4-point improvement in Itch Numerical Rating Scale (Itch NRS) from baseline	Week 12
Secondary	Change from baseline in Clinical Lichen Sclerosus Score (CLISSCO) score	The CLISSCO is a validated tool to assess disease severity in lichen sclerosus. Symptoms, signs, and architectural changes will be rated on a 4-point Likert scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe).	Week 12
Secondary	Change from baseline in the Skin Pain NRS score	Defined as skin pain severity on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) in the past 24 hours.	Week 12
Secondary	Time to achieve ITCH4	ITCH4 response defined as a = 4-point improvement in Itch Numerical Rating Scale (Itch NRS) from baseline	Up to Week 24
Secondary	Number of Treatment Emergent Adverse Events (TEAEs))	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.	Up to 28 weeks