Researchers are looking for boys and men living with Duchenne muscular dystrophy, ages 12 years and older, to participate in a phase 2 clinical trial, sponsored by FibroGen, to test the experimental drug FG-3019 (pamrevlumab).
The study, known as “MissionDMD,” is designed to help researchers evaluate whether FG-3019 is safe and effective in people with DMD and determine how the drug distributes through the body.
In DMD, abnormally high levels of a naturally occurring protein called Connective Tissue Growth Factor (CTGF) are present in muscles, leading to fibrosis (scarring) in the tissue. FG-3019, a monoclonal antibody (a molecule, produced in the laboratory, that’s engineered to mimic antibodies normally produced by the body as part of an immune response), is designed to block CTGF. Researchers hope the experimental drug will reduce fibrosis in skeletal and cardiac muscle and lead to improved function in the arms and legs, breathing muscles, and heart.
All MissionDMD participants will receive treatment with FG-3019. They must attend clinic visits every two weeks for a period of two years at which they may undergo muscle function testing, lung function testing and Magnetic Resonance Imaging (MRI), and may have blood drawn. (MRI is an imaging technique that allows doctors to look inside the body using a scanner that sends out a strong magnetic field and radio waves. The procedure is painless, noninvasive and does not use radiation.)
Participants must be non-ambulatory (unable to walk), have a genetically confirmed diagnosis of DMD, be 12 years or older, and meet additional criteria.
The study is being conducted at nine trial sites in the United States, and participants are eligible for reimbursement for some costs related to travel and overnight lodging associated with clinic visits.
For more information about this trial, including trial site locations and complete eligibility criteria, please visit ClinicalTrials.gov and enter NCT02606136 into the search box. If you or someone you know may be interested in participating in this trial, contact Gustavo Lorente at (415) 978-1441 or glorente@fibrogen.com.
