CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 327 enrolled
Drug / intervention
SAR156597 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02345070
NCT02345070Phase 2Completed
CompareCT.gov

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

Sanofi·interventional·Posted Jan 26, 2015·Updated Mar 24, 2022

In Brief

A Phase 2 clinical trial evaluating SAR156597 and placebo for Idiopathic Pulmonary Fibrosis. Completed, enrolled 327 participants across 101 sites in 19 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
CountriesArgentina, Australia, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Mexico, Portugal, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 26, 2015
Enrollment StartMay 1, 2015
Primary CompletionMay 22, 2017
Study CompletionAug 14, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.4 years ago

Interventions

SAR156597drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous

placebodrug

Pharmaceutical form: solution for injection Route of administration: subcutaneous