Last updated on June 2020

Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis


Brief description of study

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of treatment with study drug is 52 weeks.

Detailed Study Description

Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome at Week 52 will be Total Improvement Score (TIS), which is a weighted composite measure of improvement from baseline in six endpoints: Physician Global Assessment of Disease Activity, Physician Assessment of Extramuscular Disease Activity, Patient Global Assessment of Disease Activity, Health Assessment Questionnaire (patient-reported disability), Manual Muscle Testing (MMT), and muscle enzymes.

Clinical Study Identifier: NCT03813160

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Northwestern University

Chicago, IL United States
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Hospital for Special Surgery

New York, NY United States
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Cleveland Clinic

Cleveland, OH United States
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University of Pennsylvania

Philadelphia, PA United States
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HonorHealth Neurology

Phoenix, AZ United States
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University of Michigan

Ann Arbor, MI United States
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Georgetown University

Washington, WA United States
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Mayo Clinic

Scottsdale, AZ United States
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Attune Health Center

Beverly Hills, CA United States
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UCLA Division of Rheumatology

Los Angeles, CA United States
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Denver Arthritis Clinic

Denver, CO United States
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Yale University

New Haven, CT United States
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Mayo Clinic

Jacksonville, FL United States
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University of Miami

Miami, FL United States
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MUSC: Department of Neurology

Charleston, SC United States
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Rheumatic Disease Center

Glendale, WI United States
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IRMED

Piotrków Trybunalski, Poland
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DelRicht Research

New Orleans, LA United States
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UMHAT

Stara Zagora, Bulgaria
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IRMED

Piotrków Trybunalski, Poland
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KLIMED

?om?a, Poland
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Klinik f r Rheumatologie

St. Gallen, Switzerland
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IRMED

Piotrków Trybunalski, Poland
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KLIMED

?om?a, Poland
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IRMED

Piotrków Trybunalski, Poland
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KLIMED

?om?a, Poland
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IRMED

Piotrków Trybunalski, Poland
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KLIMED

?om?a, Poland
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IRMED

Piotrków Trybunalski, Poland
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KLIMED

?om?a, Poland
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Hanyang University Hospital

Seoul, Korea, Republic of
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Seoul St. Mary's Hospital

Seoul, Korea, Republic of
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KLIMED

Łomża, Poland
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Klinik f r Rheumatologie

St. Gallen, Switzerland
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Inha University Hospital

Incheon, Korea, Republic of
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KLIMED

Bialystok, Poland
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Recruitment Status: Open


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