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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05593445
Recruitment Status : Completed
First Posted : October 25, 2022
Last Update Posted : January 24, 2024
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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.

Condition or disease Intervention/treatment Phase
Lichen Sclerosus Drug: Ruxolitinib cream Drug: Vehicle cream Phase 2

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study will be a 12 week double-blind period followed by a 12 week open label period.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
Actual Study Start Date : November 18, 2022
Actual Primary Completion Date : September 1, 2023
Actual Study Completion Date : December 21, 2023

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Proportion of participants with ITCH4 [ Time Frame: Week 12 ]
    ITCH4 response defined as a ≥ 4-point improvement in Itch Numerical Rating Scale (Itch NRS) from baseline


Secondary Outcome Measures :
  1. Change from baseline in Clinical Lichen Sclerosus Score (CLISSCO) score [ Time Frame: Week 12 ]
    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).

  2. Change from baseline in the Skin Pain NRS score [ Time Frame: Week 12 ]
    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.

  3. Time to achieve ITCH4 [ Time Frame: Up to Week 24 ]
    ITCH4 response defined as a ≥ 4-point improvement in Itch Numerical Rating Scale (Itch NRS) from baseline

  4. Number of Treatment Emergent Adverse Events (TEAEs)) [ Time Frame: Up to 28 weeks ]
    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females aged 18 years or older at screening with a biopsy confirmed diagnosis of Lichen Sclerosus
Accepts Healthy Volunteers:   No
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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05593445


Locations
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United States, Alabama
Cahaba Dermatology
Birmingham, Alabama, United States, 35244
United States, Arizona
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
UC Irvine
Irvine, California, United States, 92697
United States, District of Columbia
The Centers For Vulvovaginal Disorders
Washington, District of Columbia, United States, 20037
United States, Florida
New Age Medical Research Corporation
Miami, Florida, United States, 33186
United States, New York
Circuit Clinical
West Seneca, New York, United States, 14224
United States, North Carolina
Unc Dermatology and Skin Cancer Center At Southern Village
Chapel Hill, North Carolina, United States, 27516
United States, Ohio
Apex Dermatology
Ashtabula, Ohio, United States, 44004
Bexley Dermatology
Bexley, Ohio, United States, 43209
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Utah
University of Utah Health Care Midvalley Health Center Dermatology
Murray, Utah, United States, 84107
United States, Washington
Seattle Skin and Laser Clinic
Seattle, Washington, United States, 98105
Canada, Ontario
K. Papp Clinical Research
Waterloo, Ontario, Canada, N2J 1C4
Canada
Clinique Rsf
Quebec, Canada, G1V 3M7
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Haq Nawaz, MD Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT05593445    
Other Study ID Numbers: INCB 18424-220
First Posted: October 25, 2022    Key Record Dates
Last Update Posted: January 24, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Supporting Materials: Study Protocol
Statistical Analysis Plan (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.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Lichen Sclerosus
Skin Diseases
18424
Ruxolitinib
topical cream
vulvar disease
Additional relevant MeSH terms:
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Lichen Sclerosus et Atrophicus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases