A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
- Registration Number
- NCT05593445
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 61
- 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.
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Participants who do not have LS involving anogenital area.
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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.
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Laboratory values outside of the protocol-defined criteria
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Pregnant or lactating participants or those considering pregnancy during the period of their study participation..
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Other exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ruxolitinib cream 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. Ruxolitinib cream Vehicle 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. Vehicle Cream 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With ITCH4 at Week 12 Baseline; Week 12 ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12 Baseline; Week 12 The CLISSCO is a validated tool to assess disease severity in vulvar lichen sclerosus. The Clinical Lichen Sclerosus Score consists of 12 items divided into 3 sections: symptoms (3 items; likely reversible \[i.e., itch, pain, dysuria\]); signs (3 items; possibly reversible \[i.e., whitening, petechiae/ecchymosis, fissures\]); and architectural changes (6 items; irreversible \[i.e., skin fusion, perianal involvement, etc.\]). All symptoms, signs, and architectural changes were rated on a 4-point Likert scale: 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). The investigator documented the score of each of the 12 items; the CLISSCO was calculated by summing the score of each question, with a maximum score of 36 and a minimum score of 0. The higher the score, the more severe the disease. Additionally, the total score for each of the 3 sections (symptoms, signs, and architectural changes) was summarized by summing the scores of the questions in each section.
Change From Baseline in the Skin Pain NRS Score at Week 12 Baseline; Week 12 Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 12 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen sclerosus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours.
Time to Achieve ITCH4 up to 99.0 days ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period from Baseline to Week 12 plus 30 days An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period from Baseline to Week 12 plus 30 days A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Number of Participants With Any TEAE During the Open-label Extension Period from Week 12 to Week 24 plus 30 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period from Week 12 to Week 24 plus 30 days A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the CTCAE v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period from Baseline to Week 12 plus 30 days The investigator determined if a clinical laboratory test value was clinically meaningful.
Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period from Baseline to Week 12 plus 30 days The investigator determined if a clinical laboratory test value was clinically meaningful.
Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension Period from Week 12 to Week 24 plus 30 days The investigator determined if a clinical laboratory test value was clinically meaningful.
Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension Period from Week 12 to Week 24 plus 30 days The investigator determined if a clinical laboratory test value was clinically meaningful.
Trial Locations
- Locations (14)
New Age Medical Research Corporation
🇺🇸Miami, Florida, United States
UC Irvine
🇺🇸Irvine, California, United States
Circuit Clinical
🇺🇸West Seneca, New York, United States
Bexley Dermatology
🇺🇸Bexley, Ohio, United States
University of Utah Health Care Midvalley Health Center Dermatology
🇺🇸Murray, Utah, United States
K. Papp Clinical Research
🇨🇦Waterloo, Ontario, Canada
Clinique Rsf
🇨🇦Quebec, Canada
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Seattle Skin and Laser Clinic
🇺🇸Seattle, Washington, United States
Apex Dermatology
🇺🇸Ashtabula, Ohio, United States
The Centers For Vulvovaginal Disorders
🇺🇸Washington, District of Columbia, United States
Mayo Clinic - Scottsdale
🇺🇸Scottsdale, Arizona, United States
Cahaba Dermatology
🇺🇸Birmingham, Alabama, United States
Unc Dermatology and Skin Cancer Center At Southern Village
🇺🇸Chapel Hill, North Carolina, United States