Last updated on February 2018

Trial of Pamrevlumab (FG-3019) in Non-Ambulatory Subjects With Duchenne Muscular Dystrophy (DMD)

Brief description of study

This is a Phase 2, open-label, single arm trial of pamrevlumab (FG-3019) to estimate pamrevlumab's safety and efficacy in non-ambulatory subjects with DMD.

Detailed Study Description

Each subject will receive pamrevlumab (35 mg/kg) every two weeks by intravenous infusion for up to 156 weeks. After at least 10 to 12 subjects complete one year of treatment interim analysis may increase total subjects enrolled to approximately 32. All subjects will be closely monitored for safety. Efficacy assessments will be performed routinely over the course of the study.

Clinical Study Identifier: NCT02606136

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Perry Shieh, MD

David Geffen School of Medicine at UCLA
Los Angeles, CA United States
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Jonathan Strober, MD

University of California San Francisco - Benioff Children's Hospital
San Francisco, CA United States
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Joanne Janas, MD

Children's Hospital Colorado
Aurora, CO United States
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Basil Darras, MD

Boston Children's Hospital
Boston, MA United States
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Anne Connolly, MD

Washington University in St. Louis School of Medicine
Saint Louis, MO United States
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Cuixia Tian, MD

Cincinnati Children's Hospital Medical Center
Cincinnati, OH United States
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Erika L Finanger, MD

Shriner's Hospital for Children - Portland
Portland, OR United States
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John Brandsema, MD

The Children's Hospital of Philadelphia
Philadelphia, PA United States
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Diana Castro, MD

Children's Medical Center Ambulatory Care Pavilion
Dallas, TX United States
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