A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
NCT ID: NCT05593432
Last Updated: 2024-10-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2022-11-23
2024-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ruxolitinib cream
Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.
Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Vehicle Cream
Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.
Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Interventions
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Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
1. 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.
2. Active ongoing inflammatory diseases of the skin other than LP that might confound the evaluation of LP lesions or compromise participant safety.
3. 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.
4. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).
5. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
6. 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Haq Nawaz, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INCB 18424-216
Identifier Type: -
Identifier Source: org_study_id
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