Last updated on April 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

Jonathan Strober, MD

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

Joanne Janas, MD

Children's Hospital Colorado
Aurora, CO United States

Basil Darras, MD

Boston Children's Hospital
Boston, MA United States

Anne Connolly, MD

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

Cuixia Tian, MD

Cincinnati Children's Hospital Medical Center
Cincinnati, OH United States

Erika L Finanger, MD

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

John Brandsema, MD

The Children's Hospital of Philadelphia
Philadelphia, PA United States

Diana Castro, MD

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

Han Phan, MD

Rare Disease Research
Atlanta, GA United States