Faculty

Augustine S. Lee, M.D.

Clinical Studies

A Randomized, Double-blind, Active-controlled 52-week Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab Compared to Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Patients Receiving Standard of Care Therapy (MANDARA) Jacksonville, Fla. This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC) injection every 4th week in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy. All patients who complete the 52-week double-blind treatment period on IP may be eligible to continue into an open label extension (OLE) period. The OLE period is intended to allow each patient at least 1 year of treatment with open-label benralizumab 30 mg administered SC every 4th week (earlier enrolled patients may therefore be in the OLE for longer than 1 year).

An Open-label Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-OLE) Rochester, Minn., Jacksonville, Fla.
The purpose of this study is to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects with Idiopathic Pulmonary Fibrosis (IPF) (RAINIER) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine if Simtuzumab (GS-6624) is safe and effective in treating Idiopathic Pulmonary Fibrosis.
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis (RIN-PF-301) Rochester, Minn., Jacksonville, Fla.
The primary objective of this study is to evaluate the safety and effectiveness of inhaled treprostinil in subjects with Idiopathic Pulmonary Fibrosis (IPF).
Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough Jacksonville, Fla.
This is a mechanistic research study to evaluate the relationship between cough, reflux, and aspiration in patients with systemic sclerosis (scleroderma).