Back to resultsA Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
Primary Purpose
Cutaneous Lichen Planus
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ruxolitinib cream
Vehicle cream
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Lichen Planus focused on measuring Lichen Planus, Skin Diseases, 18424, Ruxolitinib, topical cream
Eligibility Criteria
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:
- 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.
Sites / Locations
- Cahaba Dermatology
- Medical Dermatology Specialists Phoenix
- Mayo Clinic Arizona
- Wallace of Beverly Hills
- Northshore Medical Group Dermatology Skokie
- Dawes Fretzin Clinical Research Group Llc
- Delricht Clinical Research-Clinedge-Ppds Baton Rouge
- Delricht Research - Touro Medical Center
- Dermassociates
- Minnesota Clinical Study Center
- Jdr Dermatology Research
- OPTISKIN
- Bexley Dermatology
- Clinohio Research Services
- Apex Clinical Research Center
- Central Sooner Research
- Oregon Medical Research Center
- University of Pennsylvania-Perelman School of Medicine
- International Clinical Research Ic Research Murfreesboro
- Arlington Center For Dermatology
- Austin Institute For Clinical Research Aicr Pflugerville
- University of Utah Health Care Midvalley Health Center Dermatology
- Wiseman Dermatology Research Inc
- Dr. S. K. Siddha Medicine Professional Corporation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ruxolitinib cream
Vehicle Cream
Arm Description
Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.
Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of Participants achieving IGA-TS
Defined as the percentage of participants achieving IGA-TS at each scheduled postbaseline visit.
Proportion of Participants with ITCH4 response
Defined as a ≥ 4-point improvement in the Itch Numeric Rating Scale (Itch NRS) score from baseline.
Time to achieve ITCH4
Time to achieve >=4 point improvement in Itch NRS score
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05593432
Brief Title
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
Official Title
A Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
October 2, 2023 (Anticipated)
Study Completion Date
February 19, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Lichen Planus
Keywords
Lichen Planus, Skin Diseases, 18424, Ruxolitinib, topical cream
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Study will include a 16 week double-blind period followed by a 16 week open-label period.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ruxolitinib cream
Arm Type
Experimental
Arm Description
Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.
Arm Title
Vehicle Cream
Arm Type
Placebo Comparator
Arm Description
Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib cream
Other Intervention Name(s)
INCB018424 cream
Intervention Description
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Intervention Type
Drug
Intervention Name(s)
Vehicle cream
Intervention Description
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Primary Outcome Measure Information:
Title
Proportion of Participants with Investigator's Global Assessment Treatment Success (IGA-TS)
Description
Defined as an IGA score of 0 or 1 with ≥ 2-grade improvement from baseline.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Proportion of Participants achieving IGA-TS
Description
Defined as the percentage of participants achieving IGA-TS at each scheduled postbaseline visit.
Time Frame
Up to Week 32
Title
Proportion of Participants with ITCH4 response
Description
Defined as a ≥ 4-point improvement in the Itch Numeric Rating Scale (Itch NRS) score from baseline.
Time Frame
Up to Week 32
Title
Time to achieve ITCH4
Description
Time to achieve >=4 point improvement in Itch NRS score
Time Frame
Up to Week 32
Title
Change from baseline in the Skin Pain Numeric Rating Scale (NRS) score
Description
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.
Time Frame
Up to Week 32
Title
Number of Treatment Emergent Adverse Events (TEAEs)
Description
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time Frame
Up to 36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haq Nawaz, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Cahaba Dermatology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Medical Dermatology Specialists Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Wallace of Beverly Hills
City
Los Angeles
State/Province
California
ZIP/Postal Code
90056
Country
United States
Facility Name
Northshore Medical Group Dermatology Skokie
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group Llc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Delricht Clinical Research-Clinedge-Ppds Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Delricht Research - Touro Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Dermassociates
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Minnesota Clinical Study Center
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Jdr Dermatology Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
OPTISKIN
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Bexley Dermatology
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Clinohio Research Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Apex Clinical Research Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
University of Pennsylvania-Perelman School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5160
Country
United States
Facility Name
International Clinical Research Ic Research Murfreesboro
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130-2450
Country
United States
Facility Name
Arlington Center For Dermatology
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011-3800
Country
United States
Facility Name
Austin Institute For Clinical Research Aicr Pflugerville
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
University of Utah Health Care Midvalley Health Center Dermatology
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Wiseman Dermatology Research Inc
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Dr. S. K. Siddha Medicine Professional Corporation
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.incyte.com/our-company/compliance-and-transparency
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
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