Clinical trial NCT05593445: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lichen Sclerosus
Keywords: Lichen Sclerosus
Skin Diseases
18424
Ruxolitinib
topical cream
vulvar disease
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-10-25
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study will be a 12 week double-blind period followed by a 12 week open label period.
Primary purpose: TREATMENT

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.


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:

  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.

Primary outcomes:
measure: Percentage of Participants With ITCH4 at Week 12
timeFrame: Baseline; Week 12
Secondary outcomes:
measure: Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the Skin Pain NRS Score at Week 12
timeFrame: Baseline; Week 12
measure: Time to Achieve ITCH4
timeFrame: up to 99.0 days
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period
timeFrame: from Baseline to Week 12 plus 30 days
measure: Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period
timeFrame: from Baseline to Week 12 plus 30 days
measure: Number of Participants With Any TEAE During the Open-label Extension Period
timeFrame: from Week 12 to Week 24 plus 30 days
measure: Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period
timeFrame: from Week 12 to Week 24 plus 30 days
measure: Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period
timeFrame: from Baseline to Week 12 plus 30 days
measure: Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period
timeFrame: from Baseline to Week 12 plus 30 days
measure: Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension Period
timeFrame: from Week 12 to Week 24 plus 30 days
measure: Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension Period
timeFrame: from Week 12 to Week 24 plus 30 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic - Scottsdale
state: Arizona
city: Irvine
country: United States
facility: UC Irvine
state: California
city: Washington
country: United States
facility: The Centers For Vulvovaginal Disorders
state: District of Columbia
city: Miami
country: United States
facility: New Age Medical Research Corporation
state: Florida
city: West Seneca
country: United States
facility: Circuit Clinical
state: New York
city: Chapel Hill
country: United States
facility: Unc Dermatology and Skin Cancer Center At Southern Village
state: North Carolina
city: Ashtabula
country: United States
facility: Apex Dermatology
state: Ohio
city: Bexley
country: United States
facility: Bexley Dermatology
state: Ohio
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Murray
country: United States
facility: University of Utah Health Care Midvalley Health Center Dermatology
state: Utah
city: Seattle
country: United States
facility: Seattle Skin and Laser Clinic
state: Washington
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Quebec
country: Canada
facility: Clinique Rsf
Study officials:
affiliation: Incyte Corporation
name: Haq Nawaz, MD
role: STUDY_DIRECTOR
References: