Date: 2015-01-19
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Sanofi (France)
Product: SAR156597
Action
mechanism: bispecific antibody. SAR156597 is a bispecific anibody against interleukin-4 (IL-4) and interleukin-13 (IL-13).
Disease: idiopathic pulmonary fibrosis
Therapeutic area: Lung diseases - Respiratory diseases - Rare diseases
Country: Argentina, Australia, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Republic of Korea, Mexico, Spain, Turkey, UK, USA
Trial
details: This randomized, double-blind, placebo-controlled, 52-week dose-ranging Study (ESTAIR) will evaluate the efficacy and the safety of SAR156597 in the treatment of idiopathic pulmonary fibrosis (IPF).
Primary 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 Idiopathic Pulmonary Fibrosis (IPF). Secondary Objectives: To evaluate the efficacy of 2 dose levels of SAR156597 compared to placebo on IPF disease progression. To evaluate the safety of 2 dose levels of SAR156597 compared to placebo in patients with IPF. (NCT02345070)
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