Last updated on July 2019

Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

Brief description of study

This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. Approximately 415 subjects will be enrolled in this study at about 100 sites in North America, Europe, and Australia. The planned duration of treatment with study drug is 28 weeks.

Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.

Clinical Study Identifier: NCT03451045

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North Shore LIJ Health System

New Hyde Park, NY United States
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Queen's Medical Centre

Nottingham, United Kingdom
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Belfast City Hospital

Belfast, United Kingdom
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Phoenix Children's Hospital

Phoenix, AZ United States
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Miller Children's Hospital

Long Beach, CA United States
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National Jewish Health

Denver, CO United States
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University of Miami

Miami, FL United States
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Emory Children's Center

Atlanta, GA United States
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Johns Hopkins University

Baltimore, MD United States
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Morristown Medical Center

Morristown, NJ United States
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New York Medical College

Hawthorne, NY United States
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Mount Sinai Beth Israel

New York, NY United States
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Cook Children's Medical Center

Fort Worth, TX United States
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University of Utah

Salt Lake City, UT United States
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Radbound UMC

Nijmegen, Netherlands
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Children's City Hospital of Saint Olga

Saint Petersburg, Russian Federation
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Barts Health NHS Trust

London, United Kingdom
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Recruitment Status: Open

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