Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - DRI11772

SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT0 个研究点目标入组 327 人开始时间: 2021年5月27日最近更新: 2021年8月17日

适应症

试验速览

暂无简介。

•- 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)

发起方

SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT