Sanofi is currently recruiting participants to enroll in a phase 2 clinical trial designed to assess the safety and efficacy of its product SAR156597 in the treatment of idiopathic pulmonary fibrosis (IPF). The study is entitled “Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (ESTAIR): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study,” and the clinical trial is registered under the identifier NCT02345070.
IPF is a progressive fatal lung disease of unknown origin in which the alveoli and the lung tissue are damaged, becoming thick and scarred (fibrosis), leading to severe breathing difficulties and compromising oxygen transfer between the lungs and the bloodstream. The disorder is characterized by a shortness of breath (dyspnea) that gradually worsens, with respiratory failure being the main cause of death associated with it. There is no cure for IPF and it is estimated that almost 130,000 individuals in the United States and 5 million worldwide suffer from the disease. IPF has a poor prognosis and around two-thirds of the patients die within five years after being diagnosed.
SAR156597 is an experimental therapy developed by Sanofi for the treatment of IPF. It is a bispecific monoclonal antibody against interleukin (IL)-4 and IL-13, two molecules that have been implicated as mediators of IPF development.
The primary goal of the clinical trial is to assess the safety and efficacy of SAR156597 given subcutaneously for a period of 52 weeks on the lung function and disease progression of IPF patients. SAR156597 will be compared to a placebo and tested on two different regimens: a subcutaneous injection once every week or once every two weeks.
Sanofi plans to enroll up to 300 individuals aged 40 years or older with an IPF diagnosis. The total duration of the study is planned to be 68 weeks, taking into account a 4-week screening period, 52 weeks of treatment and a 12-week follow-up period.
If you are interested in participating in this clinical trial or would like to obtain more information, please contact Sanofi through at [email protected] To access a list of the 40 study locations involved in the trial and respective contacts, please visit the following link.