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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
327
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at 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.
Time frame: Baseline, Week 52
Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at 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 frame: From randomization to disease progression (up to Week 52)
Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at 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.
Time frame: From randomization up to Week 52
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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
...and 91 more locations