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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: subcutaneous
Investigational Site Number 840008
Sacramento, California, United States
Safety/tolerability: Number of participants with Adverse events
Time frame: from first dose of study drug up to Week 18
Pharmacodynamic: Change in forced (expiratory) vital capacity (FVC)
Time frame: from baseline to week 6
Pharmacodynamic: Change in carbon monoxide diffusing lung capacity (DLco)
Time frame: from baseline to week 6
Pharmacodynamic: Change in Saint George Respiratory Questionnaire (SGRQ)
Time frame: from baseline to week 6
Pharmacodynamic: Change in plasma levels of biomarkers
Time frame: from baseline to week 18
Pharmacokinetic: SAR156597 plasma concentration
Time frame: from baseline to week 18
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Investigational Site Number 840009
Jacksonville, Florida, United States
Investigational Site Number 840011
Jacksonville, Florida, United States
Investigational Site Number 840006
Chicago, Illinois, United States
Investigational Site Number 840004
Joliet, Illinois, United States
Investigational Site Number 840005
Maywood, Illinois, United States
Investigational Site Number 840002
Wichita, Kansas, United States
Investigational Site Number 840003
Minneapolis, Minnesota, United States
Investigational Site Number 840013
New York, New York, United States
Investigational Site Number 840014
Cincinnati, Ohio, United States
...and 11 more locations