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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Repeated Doses of SAR156597 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: SAR156597
* Drug: Placebo (for SAR156597)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR156597 dose 1<br>SAR156597 dose 1, subcutaneous injection once every week | Drug: SAR156597<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>|
| Experimental: SAR156597 dose 2<br>SAR156597 dose 2, subcutaneous injection once every week | Drug: SAR156597<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>|
| Experimental: SAR156597 dose 3<br>SAR156597 dose 3, subcutaneous injection once every week | Drug: SAR156597<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>|
| Placebo Comparator: Placebo<br>Placebo (for SAR156597), subcutaneous injection once every week | Drug: Placebo (for SAR156597)<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/tolerability: Number of participants with Adverse events |  | from first dose of study drug up to Week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |