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

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

The purpose of this study will be to evaluate efficacy and safety of Ruxolitinib cream in participants With Cutaneous Lichen Planus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 16 weeks followed by an open label period (OLE) period of 16 weeks.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 64
• 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
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research Inc
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Dr. S. K. Siddha Medicine Professional Corporation
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Cahaba Dermatology
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Medical Dermatology Specialists Phoenix
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Arizona
  • California
    • Los Angeles, California, United States, 90056
      • Wallace of Beverly Hills
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Northshore Medical Group Dermatology Skokie
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group Llc
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Delricht Clinical Research-Clinedge-Ppds Baton Rouge
    • New Orleans, Louisiana, United States, 70115
      • Delricht Research - Touro Medical Center
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Dermassociates
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Jdr Dermatology Research
  • New York
    • New York, New York, United States, 10128
      • OPTISKIN
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Bexley Dermatology
    • Columbus, Ohio, United States, 43213
      • ClinOhio Research Services
    • Mayfield Heights, Ohio, United States, 44124
      • Apex Clinical Research Center
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-5160
      • University of Pennsylvania-Perelman School of Medicine
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130-2450
      • International Clinical Research Ic Research Murfreesboro
  • Texas
    • Arlington, Texas, United States, 76011-3800
      • Arlington Center for Dermatology
    • Pflugerville, Texas, United States, 78660
      • Austin Institute For Clinical Research Aicr Pflugerville
  • Utah
    • Murray, Utah, United States, 84107
      • University of Utah Health Care Midvalley Health Center Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of LP with predominant cutaneous involvement.
• IGA score of 3 or 4 at screening and baseline.
• Baseline LP-related Itch NRS score ≥ 4.
• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

• Concurrent conditions and history of other diseases:

  1. Variants of LP deemed by the investigators to be inappropriate for topical treatment, including but not limited to predominant mucosal (such as oral or vaginal) LP.
  2. Active ongoing inflammatory diseases of the skin other than LP that might confound the evaluation of LP lesions or compromise participant safety.
  3. Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of LP lesions or compromise participant safety.
  4. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).
  5. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
  6. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, or impetigo) within 1 week 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 exclusive 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 16 weeks, followed by ruxolitinib cream BID 16-week 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 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week 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 Investigator's Global Assessment Treatment Success (IGA-TS)	Defined as an IGA score of 0 or 1 with ≥ 2-grade improvement from baseline.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants achieving IGA-TS	Defined as the percentage of participants achieving IGA-TS at each scheduled postbaseline visit.	Up to Week 32
Proportion of Participants with ITCH4 response	Defined as a ≥ 4-point improvement in the Itch Numeric Rating Scale (Itch NRS) score from baseline.	Up to Week 32
Time to achieve ITCH4	Time to achieve >=4 point improvement in Itch NRS score	Up to Week 32
Change from baseline in the Skin Pain Numeric Rating Scale (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.	Up to Week 32
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 36 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 23, 2022
• Primary Completion (Actual): October 2, 2023
• Study Completion (Actual): February 26, 2024

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 (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Ruxolitinib; Skin Diseases; 18424; topical cream; Lichen Planus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus
• Other Study ID Numbers: INCB 18424-216

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