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

Sponsor

Incyte Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05593432

Collaborator

(none)

Enrollment

Locations

Arms

14.9

Anticipated Duration (Months)

8.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study will be to evaluate efficacy and safety of Ruxolitinib cream in participants With Cutaneous Lichen Planus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 16 weeks followed by an open label period (OLE) period of 16 weeks.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Lichen Planus	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 include a 16 week double-blind period followed by a 16 week open-label period.Study will include a 16 week double-blind period followed by a 16 week open-label period.

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus

Actual Study Start Date :

Nov 23, 2022

Anticipated Primary Completion Date :

Oct 10, 2023

Anticipated Study Completion Date :

Feb 19, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ruxolitinib cream Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week 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 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week 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 16 weeks, followed by ruxolitinib cream BID 16-week 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 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week 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 Investigator's Global Assessment Treatment Success (IGA-TS) [Week 16]
Defined as an IGA score of 0 or 1 with ≥ 2-grade improvement from baseline.

Secondary Outcome Measures

Proportion of Participants achieving IGA-TS [Up to Week 32]
Defined as the percentage of participants achieving IGA-TS at each scheduled postbaseline visit.
Proportion of Participants with ITCH4 response [Up to Week 32]
Defined as a ≥ 4-point improvement in the Itch Numeric Rating Scale (Itch NRS) score from baseline.
Time to achieve ITCH4 [Up to Week 32]
Time to achieve >=4 point improvement in Itch NRS score
Change from baseline in the Skin Pain Numeric Rating Scale (NRS) score [Up to Week 32]
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.
Number of Treatment Emergent Adverse Events (TEAEs) [Up to 36 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:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of LP with predominant cutaneous involvement.
IGA score of 3 or 4 at screening and baseline.
Baseline LP-related Itch NRS score ≥ 4.
Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

Concurrent conditions and history of other diseases:

Variants of LP deemed by the investigators to be inappropriate for topical treatment, including but not limited to predominant mucosal (such as oral or vaginal) LP.
Active ongoing inflammatory diseases of the skin other than LP that might confound the evaluation of LP lesions or compromise participant safety.
Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of LP lesions or compromise participant safety.
Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).
Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, or impetigo) within 1 week 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 exclusive criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cahaba Dermatology	Birmingham	Alabama	United States	35244
2	Delricht Clinical Research - Clinedge - Ppds Baton Rouge	Baton Rouge	Louisiana	United States	70809
3	Bexley Dermatology	Bexley	Ohio	United States	43209
4	Oregon Medical Research Center	Portland	Oregon	United States	97223
5	Arlington Center For Dermatology	Arlington	Texas	United States	76011-3800
6	Wiseman Dermatology Research Inc	Winnipeg	Manitoba	Canada	R3M 3Z4
7	Dr. S. K. Siddha Medicine Professional Corporation	Newmarket	Ontario	Canada	L3Y 5G8