NCT05593432

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2022

Shorter than P25 for phase_2

Geographic Reach
2 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

November 23, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2024

Completed
8 months until next milestone

Results Posted

Study results publicly available

October 24, 2024

Completed
Last Updated

October 24, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

October 21, 2022

Results QC Date

September 30, 2024

Last Update Submit

September 30, 2024

Conditions

Cutaneous Lichen Planus

Keywords

Lichen PlanusSkin Diseases18424Ruxolitinibtopical cream

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16

    The Investigator's Global Assessment (IGA) is a modified global assessment tool to assess the severity of lesions. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at Week 16.

    Baseline; Week 16

Secondary Outcomes (11)

  • Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period

    Baseline; Weeks 2, 4, 8, 12, and 16

  • Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period

    Baseline; Weeks 18, 20, 24, 28, and 32

  • Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period

    Baseline; Weeks 2, 4, 8, 12, and 16

  • Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period

    Baseline; Weeks 18, 20, 24, 28, and 32

  • Time to Achieve ITCH4 in the Double-blind, Vehicle-controlled Period

    up to Week 16

  • +6 more secondary outcomes

Study Arms (2)

Ruxolitinib cream

EXPERIMENTAL

Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.

Drug: Ruxolitinib creamDrug: Vehicle cream

Vehicle Cream

PLACEBO COMPARATOR

Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.

Drug: Vehicle cream

Interventions

Ruxolitinib creamDRUG

Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

Also known as: INCB018424 cream
Ruxolitinib cream
Vehicle creamDRUG

Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Ruxolitinib creamVehicle Cream

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Concurrent conditions and history of other diseases:
  • 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.
  • Active ongoing inflammatory diseases of the skin other than LP that might confound the evaluation of LP lesions or compromise participant safety.
  • 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.
  • Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).
  • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Cahaba Dermatology

Birmingham, Alabama, 35244, United States

Location

Medical Dermatology Specialists Phoenix

Phoenix, Arizona, 85006, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Wallace of Beverly Hills

Los Angeles, California, 90056, United States

Location

Northshore Medical Group Dermatology Skokie

Skokie, Illinois, 60077, United States

Location

Dawes Fretzin Clinical Research Group Llc

Indianapolis, Indiana, 46250, United States

Location

Delricht Clinical Research-Clinedge-Ppds Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

Delricht Research - Touro Medical Center

New Orleans, Louisiana, 70115, United States

Location

Dermassociates

Rockville, Maryland, 20850, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

Jdr Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

OPTISKIN

New York, New York, 10128, United States

Location

Bexley Dermatology

Bexley, Ohio, 43209, United States

Location

Clinohio Research Services

Columbus, Ohio, 43213, United States

Location

Apex Clinical Research Center

Mayfield Heights, Ohio, 44124, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

University of Pennsylvania-Perelman School of Medicine

Philadelphia, Pennsylvania, 19104-5160, United States

Location

International Clinical Research Ic Research Murfreesboro

Murfreesboro, Tennessee, 37130-2450, United States

Location

Arlington Center For Dermatology

Arlington, Texas, 76011-3800, United States

Location

Austin Institute For Clinical Research Aicr Pflugerville

Pflugerville, Texas, 78660, United States

Location

University of Utah Health Care Midvalley Health Center Dermatology

Murray, Utah, 84107, United States

Location

Wiseman Dermatology Research Inc

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Dr. S. K. Siddha Medicine Professional Corporation

Newmarket, Ontario, L3Y 5G8, Canada

Location

MeSH Terms

Conditions

Lichen PlanusSkin Diseases

Condition Hierarchy (Ancestors)

Lichenoid EruptionsSkin Diseases, PapulosquamousSkin and Connective Tissue Diseases

Results Point of Contact

Title
Study Director
Organization
Incyte Corporation
medinfo@incyte.com
1-855-463-3463

Study Officials

  • Haq Nawaz, MD

    Incyte Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study will include a 16 week double-blind period followed by a 16 week open-label period.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

October 21, 2022

First Posted

October 25, 2022

Study Start

November 23, 2022

Primary Completion

October 2, 2023

Study Completion

February 26, 2024

Last Updated

October 24, 2024

Results First Posted

October 24, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
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
More information

Locations

US(22)CA(2)