Dataset from A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis

The primary objective of this study is to evaluate the efficacy of BG00011 compared with
placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). The secondary objectives of
this study are: to evaluate the efficacy of BG00011 compared with placebo in participants
with IPF as determined by change in percent predicted forced (expiratory) vital capacity
(FVC); to assess progression-free survival in participants who receive BG00011 compared with
placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011
compared with placebo; to assess the incidence of absolute decline in FVC ≥10% in
participants who receive BG00011 compared with placebo; to assess the time to death or lung
transplantation in participants who receive BG00011 compared with placebo, and the
transplant-free survival rate at Week 26 and Week 52; to assess the time to non-elective
hospitalizations in participants who receive BG00011 compared with placebo; to assess
additional pulmonary function test (PFT) findings in participants who receive BG00011
compared with placebo; To assess performance on the 6 minute walk test (6MWT) in participants
who receive BG00011 compared with placebo; to evaluate the safety and tolerability of
BG00011; and to evaluate the serum concentration of BG00011.