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/ / 203PF203
An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
PLS AVAILABLE
Study Identifier203PF203
Clinicaltrials.gov
#NCT03573505
Details
Development Status
Discontinued
Study Type
Interventional
Results Available
Yes
Study Dates
09/2018 - 11/2019
Enrollment
109
Study Drug
Placebo, BG00011
Summary
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 compare...
Study Results
View and download the Results Summaries with the results of this completed study.
PDF
CSR Synopsis
PDF Document
PDF
Plain Language Summary
PDF Document
View study results on registries