Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 327
Not provided
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 840017
🇺🇸Atlanta, Georgia, United States
Investigational Site Number 840009
🇺🇸Minneapolis, Minnesota, United States
Investigational Site Number 840013
🇺🇸Stony Brook, New York, United States
Investigational Site Number 840011
🇺🇸Dallas, Texas, United States
Investigational Site Number 208002
🇩🇰Aarhus C, Denmark
Investigational Site Number 792002
🇹🇷Izmir, Turkey
Investigational Site Number 840003
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 250006
🇫🇷Paris, France
Investigational Site Number 250001
🇫🇷Lyon, France
Investigational Site Number 250005
🇫🇷Montpellier, France
Investigational Site Number 250003
🇫🇷Tours, France
Investigational Site Number 410001
🇰🇷Incheon, Korea, Republic of
Investigational Site Number 410003
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 840020
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840015
🇺🇸Jamaica, New York, United States
Investigational Site Number 840008
🇺🇸Decatur, Georgia, United States
Investigational Site Number 840010
🇺🇸Louisville, Kentucky, United States
Investigational Site Number 840002
🇺🇸Summit, New Jersey, United States
Investigational Site Number 840012
🇺🇸New York, New York, United States
Investigational Site Number 840023
🇺🇸Mineola, New York, United States
Investigational Site Number 840024
🇺🇸Everett, Washington, United States
Investigational Site Number 840014
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 032005
🇦🇷Caba, Argentina
Investigational Site Number 032001
🇦🇷La Plata, Argentina
Investigational Site Number 032009
🇦🇷Caba, Argentina
Investigational Site Number 032004
🇦🇷Mendoza, Argentina
Investigational Site Number 036005
🇦🇺Camperdown, Australia
Investigational Site Number 032002
🇦🇷San Miguel De Tucumán, Argentina
Investigational Site Number 032007
🇦🇷Vicente Lopez, Argentina
Investigational Site Number 036004
🇦🇺Darlinghurst, Australia
Investigational Site Number 036002
🇦🇺Frankston, Australia
Investigational Site Number 036001
🇦🇺Nundah, Australia
Investigational Site Number 036003
🇦🇺Murdoch, Australia
Investigational Site Number 124003
🇨🇦Toronto, Canada
Investigational Site Number 124002
🇨🇦Vancouver, Canada
Investigational Site Number 152001
🇨🇱Santiago, Chile
Investigational Site Number 152003
🇨🇱Quillota, Chile
Investigational Site Number 152002
🇨🇱Talca, Chile
Investigational Site Number 170004
🇨🇴Armenia, Colombia
Investigational Site Number 152007
🇨🇱Viña Del Mar, Chile
Investigational Site Number 203003
🇨🇿Praha 2, Czechia
Investigational Site Number 170005
🇨🇴Cali, Colombia
Investigational Site Number 203002
🇨🇿Hradec Kralove, Czechia
Investigational Site Number 203004
🇨🇿Olomouc, Czechia
Investigational Site Number 203001
🇨🇿Praha 4, Czechia
Investigational Site Number 208001
🇩🇰Hellerup, Denmark
Investigational Site Number 250007
🇫🇷Bobigny, France
Investigational Site Number 250002
🇫🇷Lille Cedex, France
Investigational Site Number 250009
🇫🇷Marseille, France
Investigational Site Number 250004
🇫🇷Nice, France
Investigational Site Number 250008
🇫🇷Toulouse, France
Investigational Site Number 276002
🇩🇪Donaustauf, Germany
Investigational Site Number 276003
🇩🇪Coswig, Germany
Investigational Site Number 276004
🇩🇪Gießen, Germany
Investigational Site Number 376005
🇮🇱Rehovot, Israel
Investigational Site Number 276001
🇩🇪Heidelberg, Germany
Investigational Site Number 276005
🇩🇪Hannover, Germany
Investigational Site Number 300001
🇬🇷Heraklion, Greece
Investigational Site Number 376001
🇮🇱Haifa, Israel
Investigational Site Number 376004
🇮🇱Kfar Saba, Israel
Investigational Site Number 376002
🇮🇱Petah-Tikva, Israel
Investigational Site Number 380003
🇮🇹Catania, Italy
Investigational Site Number 376003
🇮🇱Tel Hashomer, Israel
Investigational Site Number 380001
🇮🇹Forlì, Italy
Investigational Site Number 380004
🇮🇹Siena, Italy
Investigational Site Number 380005
🇮🇹Milano, Italy
Investigational Site Number 380006
🇮🇹Pisa, Italy
Investigational Site Number 380002
🇮🇹Orbassano, Italy
Investigational Site Number 410005
🇰🇷Bucheon-Si, Korea, Republic of
Investigational Site Number 410006
🇰🇷Seongnam, Korea, Republic of
Investigational Site Number 410002
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410004
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 484005
🇲🇽Monterrey, Mexico
Investigational Site Number 484002
🇲🇽Mexico City, Mexico
Investigational Site Number 484003
🇲🇽San Juan Del Rio, Mexico
Investigational Site Number 724003
🇪🇸Barcelona, Spain
Investigational Site Number 724002
🇪🇸Barcelona, Spain
Investigational Site Number 724001
🇪🇸Hospitalet De Llobregat, Spain
Investigational Site Number 724004
🇪🇸Lugo, Spain
Investigational Site Number 724006
🇪🇸Majadahonda, Spain
Investigational Site Number 724005
🇪🇸Palma De Mallorca, Spain
Investigational Site Number 792005
🇹🇷Ankara, Turkey
Investigational Site Number 792001
🇹🇷Istanbul, Turkey
Investigational Site Number 724007
🇪🇸Sabadell, Spain
Investigational Site Number 792006
🇹🇷Istanbul, Turkey
Investigational Site Number 792004
🇹🇷Istanbul, Turkey
Investigational Site Number 792003
🇹🇷Istanbul, Turkey
Investigational Site Number 826002
🇬🇧Cambridge, United Kingdom
Investigational Site Number 826003
🇬🇧Exeter, United Kingdom
Investigational Site Number 826004
🇬🇧Leicester, United Kingdom
Investigational Site Number 826001
🇬🇧London, United Kingdom
Investigational Site Number 840001
🇺🇸Lebanon, New Hampshire, United States
Investigational Site Number 840026
🇺🇸Chesterfield, Missouri, United States
Investigational Site Number 840006
🇺🇸Rochester, Minnesota, United States
Investigational Site Number 840022
🇺🇸Loxahatchee Groves, Florida, United States
Investigational Site Number 152006
🇨🇱Santiago, Chile
Investigational Site Number 170001
🇨🇴Bogota, Colombia
Investigational Site Number 620003
🇵🇹Porto, Portugal
Investigational Site Number 152004
🇨🇱Santiago, Chile
Investigational Site Number 484001
🇲🇽Monterrey, Mexico
Investigational Site Number 620004
🇵🇹Vila Nova De Gaia, Portugal