29 May Evaluating the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis
This Phase 2b study is designed to evaluate the treatment effect (change in forced vital capacity [FVC]) of a single dose of BG00011 (56 mg) administered subcutaneously (SC) once weekly for 52 weeks in subjects with mild to moderate idiopathic pulmonary fibrosis (IPF) who may or may not be receiving protocol-defined background therapies (i.e., nintedanib or pirfenidone).
Study duration for an individual subject is approximately 65 weeks, including a Screening Visit
up to 5 weeks prior to the first dose of study treatment, a Placebo-Controlled Treatment Period of
52 weeks, and a Safety Follow-Up Visit 8 weeks after the end of the Treatment Period.
Aged ≥40 years
IPF diagnosed within 3 years of Screening
DLco (corrected for Hgb): 30%-79% of predicted
FVC ≥50% of predicted
Oxygen saturation ≥90% at rest
On a stable dose for nintedanib or pirfenidone at least 8 weeks prior to randomization
Additional Study Details
Full Study Title
A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis
Dr. Bridget Collins 206.598.3300
Accepts Healthy Volunteers?
1959 NE Pacific St.
Seattle, Washington 98195