NCT02345070

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

Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 327 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The total study duration of study was expected up to 68 weeks (screening period of 4 weeks, treatment period of 52 weeks, and 12 weeks of follow up).

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	SAR156597	Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG	placebo	Pharmaceutical form: solution for injection Route of administration: subcutaneous

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-05-22
• Completion: 2017-08-14
• First posted: 2015-01-26
• Last updated: 2022-03-24
• Results posted: 2020-05-26

Locations

101 sites across 19 countries: United States, Argentina, Australia, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Mexico, Portugal, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study