Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis

The total study duration of study is expected up to 68 weeks (screening period of 4 weeks,
treatment period of 52 weeks, and 12 weeks of follow up).

Inclusion criteria :

- Adult 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/ALAT) guidelines.

- Signed written informed consent.

Exclusion criteria:

- Age ≤40 years.

- IPF disease diagnosis >5 years.

- Forced vital capacity (FVC) <40% of predicted value.

- Carbon monoxide diffusing lung capacity (DLco) corrected for hemoglobin <30% of
predicted value.

- Severe chronic obstructive bronchitis as characterized by forced expiratory volume in
1 second /forced vital capacity (FEV1/FVC) <0.70.

- Need for 24 hrs of oxygen therapy or oxygen saturation <88% after 10 minutes breathing
ambient air at rest.

- Known diagnosis of significant respiratory disorders other than IPF.

- Pulmonary artery hypertension requiring a specific treatment.

- Currently listed and/or anticipated to be listed for lung transplantation within the
next 6 months (on an active list).

- History of vasculitis or connective tissue disorders.

- Known human immunodeficiency virus (HIV) or chronic viral hepatitis.

- Patients with active tuberculosis or incompletely treated latent tuberculosis
infection.

- Use of any cytotoxic/immunosuppressive agent including but not limited to
azathioprine, cyclophosphamide, methotrexate, and cyclosporine within 4 weeks prior to
screening.

- Use of any cytokine modulators (etanercept, adalimumab, efalizumab, infliximab,
golimumab, certolizumab, rituximab) within 12 weeks or 5 half-lives of screening (24
weeks for rituximab and 24 months for alefacept).

- Use of any investigational drug within 1 month of screening, or 5 half-lives, if known
( whichever is longer), or within 12 weeks for stem cell therapy.

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.