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

Inclusion Criteria

• •Written consent/assent by participant and/or legal guardian as per regional and/or institutional review board (IRB) requirements
• •Non-ambulatory
• •Brooke Score for Arms and Shoulders ≤5
• •Diagnosis of DMD by medical history and confirmed Duchenne mutation in available genetic testing using a validated genetic test
• •Able to perform spirometry
• •Able to undergo cardiac and extremity (upper arm) MRI
• •Percent predicted FVC between 40 and 90, inclusive
• •At least one historical ppFVC predicted value within 18 months of baseline
• •Left ventricular ejection fraction ≥ 45% as determined by cardiac MRI at screening or within 3 months prior to Day 0
• •Participants currently receiving heart failure cardiac medications (for example, angiotensin converting enzyme inhibitors, angiotensin-receptor blockers, and beta-blockers) must achieve a stable regimen for at least 3 months prior to screening
• •On a stable dose of corticosteroids for a minimum of 6 months prior to screening with no substantial change in dosage for a minimum of 3 months (except for adjustments for changes in body weight) prior to screening and no foreseen change in corticosteroid use during the course of study participation
• •Received pneumococcal vaccine and is receiving annual influenza vaccinations
• •Adequate renal function: cystatin C ≤1.4 mg/liter (L)
• •Adequate hematological function
• •1. Platelets \>100,000/microliter (μL)
• •2. Hemoglobin \>12 grams (g)/deciliter (dL)
• •3. Absolute neutrophil count \>1500/μL
• •Adequate hepatic function
• •1. No history or evidence of liver disease
• •2. Gamma glutamyl transferase (GGT) ≤3 x upper limit of normal (ULN)
• •3. Total bilirubin ≤1.5 x ULN
• •If sexually active, will use medically accepted contraceptives during participation in the study and for 3 months after the last dose of study drug