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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate, in comparison with placebo, the efficacy of 2 dose levels of SAR156597 administered subcutaneously during 52 weeks on lung function of patients with IPF.;Secondary Objective: To evaluate the efficacy of 2 dose levels of SAR156597 compared to placebo on IPF disease progression.<br>To evaluate the safety of 2 dose levels of SAR156597 compared to placebo in patients with IPF.;Primary end point(s): Mean absolute change from baseline in percent predicted FVC at 52 weeks;Timepoint(s) of evaluation of this end point: 1 year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Proportion of patients with disease progression <br>Number of deaths (all causes);Timepoint(s) of evaluation of this end point: 1 year

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