To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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.

Key facts

Study ID

NCT01529853

Run by

Sanofi

People needed

24

Starts

2012-01-01

Expected to finish

2013-10-01

Last updated by the study team

2016-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult (aged >18 years) male or female patients,
• Documented diagnosis of IPF according to the current American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/American Latin Thoracic Association (ATS/ERS/JRS/ALTA) guidelines

You may not qualify if…

• Forced vital capacity (FVC) <50% of predicted value Carbon monoxide diffusing lung capacity (DLCO) (corrected for hemoglobin) <35% predicted value
• Oxygen saturation <90% by pulse oximetry while breathing ambient air at rest (sitting position for 10 min)
• Known diagnosis of significant respiratory disorders other than IPF
• Active vasculopathy or use of vasoactive drugs
• Known HIV or chronic viral hepatitis
• Patients with active tuberculosis or latent tuberculosis infection
• Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical (other than IPF) or surgical disorder, or any condition that may affect patient safety in the judgment of the investigator
• Clinically significant abnormal ECG at screening
• Clinically significant laboratory tests at screening
• Current history of substance and/or alcohol abuse
• Females who are lactating or who are pregnant.
• Use of any registered therapy targeted to treat IPF within 4 weeks prior to screening
• Use of any cytotoxic/immunosuppressive agent including but not limited to azathioprine, cyclophosphamide, methotrexate and cyclosporine within 4 weeks prior to screening
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840008 — Sacramento, California, United States
• 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
• Investigational Site Number 840010 — Charleston, South Carolina, United States
• Investigational Site Number 124003 — Edmonton, Canada
• Investigational Site Number 124001 — Hamilton, Canada
• Investigational Site Number 124002 — Vancouver, Canada
• Investigational Site Number 152003 — Santiago, Chile
• Investigational Site Number 152001 — Santiago, Chile
• Investigational Site Number 152002 — Santiago, Chile
• Investigational Site Number 484003 — Mexico City, Mexico
• Investigational Site Number 484002 — Monterrey, Mexico
• Investigational Site Number 724001 — Barcelona, Spain
• Investigational Site Number 724002 — Barcelona, Spain

Full record on ClinicalTrials.gov

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