To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Drug: Placebo (for SAR156597)
- Registration Number
- NCT01529853
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To assess in adult patients with Idiopathic Pulmonary Fibrosis (IPF) the safety and tolerability of ascending doses of SAR156597 administered subcutaneously (SC) once weekly over a 6-week period.
Secondary Objectives:
To assess in adult patients with IPF:
* The pharmacodynamic effects of SAR156597, as measured on pulmonary function tests (PFTs), pulse oximetry and patient reported outcome and peripheral blood biomarkers.
* The trough plasma concentrations of SAR156597
* The potential immunogenicity of SAR156597.
- Detailed Description
The study consists of a screening period of up to 28 days, treatment period of up to 6 weeks and a post-treatment follow-up period of up to 12 weeks. Total study duration is up to 22 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR156597 dose 1 SAR156597 SAR156597 dose 1, subcutaneous injection once every week SAR156597 dose 2 SAR156597 SAR156597 dose 2, subcutaneous injection once every week SAR156597 dose 3 SAR156597 SAR156597 dose 3, subcutaneous injection once every week Placebo Placebo (for SAR156597) Placebo (for SAR156597), subcutaneous injection once every week
- Primary Outcome Measures
Name Time Method Safety/tolerability: Number of participants with Adverse events from first dose of study drug up to Week 18
- Secondary Outcome Measures
Name Time Method Pharmacodynamic: Change in plasma levels of biomarkers from baseline to week 18 Pharmacokinetic: SAR156597 plasma concentration from baseline to week 18 Pharmacodynamic: Change in forced (expiratory) vital capacity (FVC) from baseline to week 6 Pharmacodynamic: Change in carbon monoxide diffusing lung capacity (DLco) from baseline to week 6 Pharmacodynamic: Change in Saint George Respiratory Questionnaire (SGRQ) from baseline to week 6
Trial Locations
- Locations (21)
Investigational Site Number 840010
🇺🇸Charleston, South Carolina, United States
Investigational Site Number 152003
🇨🇱Santiago, Chile
Investigational Site Number 840013
🇺🇸New York, New York, United States
Investigational Site Number 840009
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 724002
🇪🇸Barcelona, Spain
Investigational Site Number 152001
🇨🇱Santiago, Chile
Investigational Site Number 724001
🇪🇸Barcelona, Spain
Investigational Site Number 124001
🇨🇦Hamilton, Canada
Investigational Site Number 840011
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 152002
🇨🇱Santiago, Chile
Investigational Site Number 484003
🇲🇽Mexico City, Mexico
Investigational Site Number 124002
🇨🇦Vancouver, Canada
Investigational Site Number 840004
🇺🇸Joliet, Illinois, United States
Investigational Site Number 840002
🇺🇸Wichita, Kansas, United States
Investigational Site Number 484002
🇲🇽Monterrey, Mexico
Investigational Site Number 124003
🇨🇦Edmonton, Canada
Investigational Site Number 840008
🇺🇸Sacramento, California, United States
Investigational Site Number 840006
🇺🇸Chicago, Illinois, United States
Investigational Site Number 840005
🇺🇸Maywood, Illinois, United States
Investigational Site Number 840003
🇺🇸Minneapolis, Minnesota, United States
Investigational Site Number 840014
🇺🇸Cincinnati, Ohio, United States