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

Primary Purpose

Lichen Sclerosus

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ruxolitinib cream
Vehicle cream
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lichen Sclerosus focused on measuring Lichen Sclerosus, Skin Diseases, 18424, Ruxolitinib, topical cream, vulvar disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cahaba Dermatology
  • Mayo Clinic - Scottsdale
  • UC Irvine
  • The Centers For Vulvovaginal Disorders
  • New Age Medical Research Corporation
  • Circuit Clinical
  • Unc Dermatology and Skin Cancer Center At Southern Village
  • Apex Dermatology
  • Bexley Dermatology
  • University of Texas Southwestern Medical Center
  • University of Utah Health Care Midvalley Health Center Dermatology
  • Seattle Skin and Laser Clinic
  • K. Papp Clinical Research
  • Clinique Rsf

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 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.

Vehicle cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.

Outcomes

Primary Outcome Measures

Proportion of participants with ITCH4
ITCH4 response defined as a ≥ 4-point improvement in Itch Numerical Rating Scale (Itch NRS) from baseline

Secondary Outcome Measures

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).
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.
Time to achieve ITCH4
ITCH4 response defined as a ≥ 4-point improvement in Itch Numerical Rating Scale (Itch NRS) from baseline
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

First Posted
October 21, 2022
Last Updated
July 17, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05593445
Brief Title
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
Official Title
A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 18, 2022 (Actual)
Primary Completion Date
September 14, 2023 (Anticipated)
Study Completion Date
December 29, 2023 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Sclerosus
Keywords
Lichen Sclerosus, Skin Diseases, 18424, Ruxolitinib, topical cream, vulvar disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Study will be a 12 week double-blind period followed by a 12 week open label period.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ruxolitinib cream
Arm Type
Experimental
Arm Description
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.
Arm Title
Vehicle Cream
Arm Type
Placebo Comparator
Arm Description
Vehicle cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an 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 ITCH4
Description
ITCH4 response defined as a ≥ 4-point improvement in Itch Numerical Rating Scale (Itch NRS) from baseline
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in Clinical Lichen Sclerosus Score (CLISSCO) score
Description
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).
Time Frame
Week 12
Title
Change from baseline in the Skin Pain 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
Week 12
Title
Time to achieve ITCH4
Description
ITCH4 response defined as a ≥ 4-point improvement in Itch Numerical Rating Scale (Itch NRS) from baseline
Time Frame
Up to Week 24
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 28 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females aged 18 years or older at screening with a biopsy confirmed diagnosis of Lichen Sclerosus
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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. Have active genital/vulvar lesions at screening and Day 1, not related to LS 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.
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
Mayo Clinic - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
UC Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
The Centers For Vulvovaginal Disorders
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
New Age Medical Research Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Circuit Clinical
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Unc Dermatology and Skin Cancer Center At Southern Village
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
Apex Dermatology
City
Ashtabula
State/Province
Ohio
ZIP/Postal Code
44004
Country
United States
Facility Name
Bexley Dermatology
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
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
Seattle Skin and Laser Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
K. Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Clinique Rsf
City
Quebec
ZIP/Postal Code
G1V 3M7
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 Lichen Sclerosus

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