Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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, and Europe. 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.

Key facts

Study ID

NCT03451045

Run by

Corbus Pharmaceuticals Inc.

People needed

447

Starts

2017-12-22

Expected to finish

2020-06-17

Last updated by the study team

2023-01-18

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 12 years of age at the time Informed Consent/ Assent is signed.
• Weight ≥ 40 kg.
• FEV1 ≥ 40% predicted and < 100% predicted in the last 12 months.
• Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months for a new PEx or physician-initiated treatment with an IV antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new PEX.

You may not qualify if…

• Severe or unstable CF at screening or Visit 1.
• Any of the following values for laboratory tests at screening:
• A positive pregnancy test.
• Hemoglobin < 10 g/dL in males and < 9 g/dL in females.
• Neutrophils < 1.0 x 10\^9 /L.
• Platelets < 75 x 10\^9/L.
• Creatinine clearance < 50 mL/min according to Modification of Diet in Renal Disease (MDRD) Study equation.
• Serum transaminases > 2.5 x upper limit of normal.
• Any medical condition or concurrent medical therapies at screening or Visit 1 that may put the subject at greater safety risk, influence response to study drug or interfere with study assessments.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Miller Children's Hospital — Long Beach, California, United States
• National Jewish Health — Denver, Colorado, United States
• University of Miami — Miami, Florida, United States
• Central Florida Pulmonary Group, PA — Orlando, Florida, United States
• USF Center for Advance Lung Disease — Tampa, Florida, United States
• Emory Children's Center — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• The Cystic Fibrosis Institute — Glenview, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Dartmouth-Hitchcock Medical Center (main location) — Lebanon, New Hampshire, United States
• Dartmouth-Hitchcock Manchester (satellite site) — Manchester, New Hampshire, United States
• Atlantic Health Children's Hospital — Morristown, New Jersey, United States
• Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• New York Medical College — Hawthorne, New York, United States
• North Shore LIJ Health System — New Hyde Park, New York, United States
• Mount Sinai Beth Israel — New York, New York, United States
• Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Milton S. Hershey Medical Center / Penn State College of Medicine — Hershey, Pennsylvania, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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