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Efficacy and Safety of SAR156...

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

Last Updated: 2022-03-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

327 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2017-08-14

Brief Summary

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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.

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Detailed Description

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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

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo qw

Participants received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks.

Group Type PLACEBO_COMPARATOR