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.

Study Overview

• Status: Completed
• Conditions: Lichen Sclerosus
• Intervention / Treatment: Drug: Ruxolitinib cream; Drug: Vehicle cream

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

Study Locations

• Canada
  • Quebec, Canada, G1V 3M7
    • Clinique Rsf
  • Ontario
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Cahaba Dermatology
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic - Scottsdale
  • California
    • Irvine, California, United States, 92697
      • UC Irvine
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • The Centers For Vulvovaginal Disorders
  • Florida
    • Miami, Florida, United States, 33186
      • New Age Medical Research Corporation
  • New York
    • West Seneca, New York, United States, 14224
      • Circuit Clinical
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • Unc Dermatology and Skin Cancer Center At Southern Village
  • Ohio
    • Ashtabula, Ohio, United States, 44004
      • Apex Dermatology
    • Bexley, Ohio, United States, 43209
      • Bexley Dermatology
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
  • Utah
    • Murray, Utah, United States, 84107
      • University of Utah Health Care Midvalley Health Center Dermatology
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Skin and Laser Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ruxolitinib cream; Ruxolitinib 1.5% cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.	Drug: Ruxolitinib cream; Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.; Other Names: INCB018424 cream; Drug: Vehicle cream; Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Placebo Comparator: Vehicle Cream; Vehicle cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.	Drug: Vehicle cream; Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Haq Nawaz, md, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Ruxolitinib; Lichen Sclerosus; Skin Diseases; 18424; topical cream; vulvar disease
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Sclerosus et Atrophicus
• Other Study ID Numbers: INCB 18424-220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No