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

Phase 2

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: placebo; Drug: SAR156597

• Registration Number: NCT02345070
• Lead Sponsor: Sanofi

Brief 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).

Study Timeline

• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-26
• Study Start: 2015-05-01
• Primary Completion: 2017-05-22
• Study Completion: 2017-08-14
• Disposition First Submitted: 2018-06-13
• Disposition First Submitted QC: 2018-06-13
• Disposition First Posted: 2018-06-15
• Results First Submitted: 2020-05-08
• Results First Submitted QC: 2020-05-08
• Results First Posted: 2020-05-26
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo qw	placebo	Participants received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks.
SAR156597 200 mg qw	SAR156597	Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
SAR156597 200 mg q2w	SAR156597	Participants received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks.
SAR156597 200 mg q2w	placebo	Participants received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks.

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52	Baseline, Week 52	FVC is a standard pulmonary function parameter measured by spirometry and used to quantify respiratory capacity (inspiration and expiration). It is a widely used objective measure of disease status in participants with Idiopathic Pulmonary Fibrosis (IPF). The primary variable was recorded as percent (%) of predicted value, which takes into account the height, gender, and age of the participant. The outcome measure measured the change in lung function from baseline at week 52.

Secondary Outcome Measures

Name	Time	Method
Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52	From randomization to disease progression (up to Week 52)	Disease progression was defined as the time from randomization to the first occurrence of any of the following events: decrease in absolute percent predicted FVC greater than or equal to (\>=) 10%, decrease in absolute percent predicted Carbon monoxide diffusing lung capacity \>=15%, lung transplant, or death. The median time to disease progression was not estimated because the number of occurrence of events was too low in the SAR156597 200 mg arms.
Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at Week 52	From randomization up to Week 52	All-cause mortality was considered for this outcome measure which was defined as the time from randomization to the date of death. The median time to event was not estimated because the number of all cause mortality was too low in the SAR156597 200 mg arms.

Trial Locations

Locations (101)

Investigational Site Number 840003; 🇺🇸 Phoenix, Arizona, United States

Investigational Site Number 840020; 🇺🇸 Jacksonville, Florida, United States

Investigational Site Number 840022; 🇺🇸 Loxahatchee Groves, Florida, United States

Investigational Site Number 840017; 🇺🇸 Atlanta, Georgia, United States

Investigational Site Number 840008; 🇺🇸 Decatur, Georgia, United States

Investigational Site Number 840010; 🇺🇸 Louisville, Kentucky, United States

Investigational Site Number 840009; 🇺🇸 Minneapolis, Minnesota, United States

Investigational Site Number 840006; 🇺🇸 Rochester, Minnesota, United States

Investigational Site Number 840026; 🇺🇸 Chesterfield, Missouri, United States

Investigational Site Number 840001; 🇺🇸 Lebanon, New Hampshire, United States

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