Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)
