Idiopathic Pulmonary Fibrosis
Conditions
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.
Interventions
DRUGSAR156597
Pharmaceutical form: solution Route of administration: subcutaneous
DRUGPlacebo (for SAR156597)
Pharmaceutical form: solution Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety/tolerability: Number of participants with Adverse events | from first dose of study drug up to Week 18 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Pharmacodynamic: Change in plasma levels of biomarkers | from baseline to week 18 |
| Pharmacokinetic: SAR156597 plasma concentration | from baseline to week 18 |
Countries
Canada, Chile, Mexico, Spain, United States
Outcome results
None listed