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

Sponsor

Incyte Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05593445

Collaborator

(none)

Enrollment

Locations

Arms

13.3

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 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.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 :

Nov 18, 2022

Anticipated Primary Completion Date :

Sep 14, 2023

Anticipated Study Completion Date :

Dec 29, 2023

Arms and Interventions

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 Names: 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.

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Proportion of participants with ITCH4 [Week 12]
ITCH4 response defined as a ≥ 4-point improvement in Itch Numerical Rating Scale (Itch NRS) from baseline

Secondary Outcome Measures

Change from baseline in Clinical Lichen Sclerosus Score (CLISSCO) score [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).
Change from baseline in the Skin Pain NRS score [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.
Time to achieve ITCH4 [Up to Week 24]
ITCH4 response defined as a ≥ 4-point improvement in Itch Numerical Rating Scale (Itch NRS) from baseline
Number of Treatment Emergent Adverse Events (TEAEs)) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cahaba Dermatology	Birmingham	Alabama	United States	35244
2	UC Irvine	Irvine	California	United States	92697
3	Bexley Dermatology	Bexley	Ohio	United States	43209
4	K Papp Clinical Research Inc	Waterloo	Ontario	Canada	N2J 1C4
5	Clinique Rsf	Quebec		Canada	G1V 3M7