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

Completed · Phase 2

Conditions studied: Cutaneous Lichen Planus

In brief

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.

Key facts

Study ID

NCT05593432

Run by

Incyte Corporation

People needed

64

Starts

2022-11-23

Expected to finish

2024-02-26

Last updated by the study team

2024-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cahaba Dermatology — Birmingham, Alabama, United States
• Medical Dermatology Specialists Phoenix — Phoenix, Arizona, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Wallace of Beverly Hills — Los Angeles, California, United States
• Northshore Medical Group Dermatology Skokie — Skokie, Illinois, United States
• Dawes Fretzin Clinical Research Group Llc — Indianapolis, Indiana, United States
• Delricht Clinical Research-Clinedge-Ppds Baton Rouge — Baton Rouge, Louisiana, United States
• Delricht Research - Touro Medical Center — New Orleans, Louisiana, United States
• Dermassociates — Rockville, Maryland, United States
• Minnesota Clinical Study Center — New Brighton, Minnesota, United States
• Jdr Dermatology Research — Las Vegas, Nevada, United States
• OPTISKIN — New York, New York, United States
• Bexley Dermatology — Bexley, Ohio, United States
• Clinohio Research Services — Columbus, Ohio, United States
• Apex Clinical Research Center — Mayfield Heights, Ohio, United States
• Central Sooner Research — Norman, Oklahoma, United States
• Oregon Medical Research Center — Portland, Oregon, United States
• University of Pennsylvania-Perelman School of Medicine — Philadelphia, Pennsylvania, United States
• International Clinical Research Ic Research Murfreesboro — Murfreesboro, Tennessee, United States
• Arlington Center For Dermatology — Arlington, Texas, United States
• Austin Institute For Clinical Research Aicr Pflugerville — Pflugerville, Texas, United States
• University of Utah Health Care Midvalley Health Center Dermatology — Murray, Utah, United States
• Wiseman Dermatology Research Inc — Winnipeg, Manitoba, Canada
• Dr. S. K. Siddha Medicine Professional Corporation — Newmarket, Ontario, Canada

Full record on ClinicalTrials.gov

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