Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR

sanofi-aventis recherche & développement0 sites327 target enrollmentStarted: October 7, 2015Last updated: December 10, 2019

Conditions

Trial Snapshot

No summary available.

•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

•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.

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