Phase 2 N=61 Randomized Triple-blind Treatment

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

Lichen Sclerosus

Bottom Line

View on ClinicalTrials.gov: NCT05593445 ↗

Enrolled (actual)

Serious AEs

1.1%

Results posted

Sep 2024

Primary outcome: Primary: Percentage of Participants With ITCH4 at Week 12 — 35.7; 40.0 percentage of participants — p=0.737

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ruxolitinib cream (Drug); Vehicle cream (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Incyte Corporation
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With ITCH4 at Week 12	35.7; 40.0	0.737
SECONDARY Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12	-5.79; -3.03	0.0188 sig
SECONDARY Change From Baseline in the Skin Pain NRS Score at Week 12	-3.22; -2.70	0.4674
SECONDARY Time to Achieve ITCH4	35.0; 28.0	0.9072
SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period	14; 12	—
SECONDARY Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period	1; 0	—
SECONDARY Number of Participants With Any TEAE During the Open-label Extension Period	13; 11	—
SECONDARY Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period	1; 0	—
SECONDARY Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period	0; 0	—
SECONDARY Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period	0; 0	—
SECONDARY Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension Period	0; 0	—
SECONDARY Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension Period	0; 0	—

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:
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05593445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.