A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
Overview
- Phase
- Phase 2
- Intervention
- Ruxolitinib cream
- Conditions
- Lichen Sclerosus
- Sponsor
- Incyte Corporation
- Enrollment
- 61
- Locations
- 14
- Primary Endpoint
- Percentage of Participants With ITCH4 at Week 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: Vehicle cream
Outcomes
Primary Outcomes
Percentage of Participants With ITCH4 at Week 12
Time Frame: 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 Outcomes
- Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12(Baseline; Week 12)
- Change From Baseline in the Skin Pain NRS Score at Week 12(Baseline; Week 12)
- Time to Achieve ITCH4(up to 99.0 days)
- 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)
- Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period(from Baseline to Week 12 plus 30 days)
- Number of Participants With Any TEAE During the Open-label Extension Period(from Week 12 to Week 24 plus 30 days)
- Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period(from Week 12 to Week 24 plus 30 days)
- 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)
- 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)
- 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)
- 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)