Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis

Summary

Primary Objective: To evaluate, in comparison with placebo, the efficacy of 2 dose levels/regimens of SAR156597 administered subcutaneously during 52 weeks on lung function of participants with Idiopathic Pulmonary Fibrosis (IPF). Secondary Objectives: To evaluate the efficacy of 2 dose levels/regimens of SAR156597 compared to placebo on IPF disease progression. To evaluate the safety of 2 dose levels/regimens of SAR156597 compared to placebo in participants with IPF.

Timeline

Start

2015-05-01

Primary completion

2017-05-22

Completion

2017-08-14

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo qw vs SAR156597 200mg qw; p = 0.6339; Least Square (LS) Mean Difference -0.5 (95% CI -2.56 to 1.56); NCT02345070 ↗

Drugs

Indications