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

Incyte Corporation24 sites in 2 countries64 target enrollmentNovember 23, 2022

ConditionsCutaneous Lichen Planus

InterventionsRuxolitinib cream Vehicle cream

DrugsRuxolitinib cream Vehicle cream

Overview

Phase: Phase 2
Intervention: Ruxolitinib cream
Conditions: Cutaneous Lichen Planus
Sponsor: Incyte Corporation
Enrollment: 64
Locations: 24
Primary Endpoint: Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 23, 2022

End Date

February 26, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Incyte Corporation

Responsible Party

Sponsor

Eligibility Criteria

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 ≥
•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.

Arms & Interventions

Ruxolitinib cream

Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.

Intervention: Ruxolitinib cream

Ruxolitinib cream

Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.

Intervention: Vehicle cream

Vehicle Cream

Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.

Intervention: Vehicle cream

Outcomes

Primary Outcomes

Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16

Time Frame: Baseline; Week 16

The Investigator's Global Assessment (IGA) is a modified global assessment tool to assess the severity of lesions. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at Week 16.

Secondary Outcomes

Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period(Baseline; Weeks 2, 4, 8, 12, and 16)
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period(Baseline; Weeks 18, 20, 24, 28, and 32)
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period(Baseline; Weeks 2, 4, 8, 12, and 16)
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period(Baseline; Weeks 18, 20, 24, 28, and 32)
Time to Achieve ITCH4 in the Double-blind, Vehicle-controlled Period(up to Week 16)
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period(Baseline; Weeks 2, 4, 8, 12, and 16)
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period(Baseline; Weeks 18, 20, 24, 28, and 32)
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period(from Baseline to Week 16 plus 30 days)
Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period(from Baseline to Week 16 plus 30 days)
Number of Participants With Any TEAE During the Open-label Extension Period(from Week 17 to Week 32 plus 30 days)
Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period(from Week 17 to Week 32 plus 30 days)