An international group of researchers are currently recruiting participants for Sanofi’s Phase 2 trial of SAR156597 for the treatment of idiopathic pulmonary fibrosis (IPF). The official title of the trial, which is now listed at ClinicalTrials.gov, is “Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study,” also known by the acronym ESTAIR.
IPF refers to a thickening and scarring of the lungs that is caused by unknown factors. The disease results in difficulty breathing and is eventually fatal. Understanding the factors that lead to scarring is critical for developing treatments for IPF, as there is currently no cure for the disease. Available treatments, such as oxygen therapy, pulmonary rehabilitation, therapeutics, or lung transplant, can help with symptoms and improve quality of life, however, there are still major unmet therapeutic needs for IPF that Sanofi is seeking to provide with its experimental IPF drug.
SAR156597 is a monocloncal antibody that specifically blocks interleukin-4 (IL-4; BSF1) and IL-13. Both interleukin-4 and interleukin-13 are cytokines that may induce inflammation — in other words, an overactive immune response. Researchers believe that inflammation may contribute to the damage that is seen in the lungs of IPF patients.
Study locations for the clinical trial include 40 different sites within the United States, Canada, the Czech Republic, Denmark, France, Israel, Italy, Korea, Mexico, Spain and Turkey. Individuals who are interested in participating can contact Sanofi at the following email: [email protected]. The researchers are trying to recruit a total of 300 participants worldwide, and estimate that the study will run from 2015-2017. The entire study is expected to run up to 68 weeks, with a screening period of 4 weeks, a treatment period of 52 weeks, and 12 follow-up weeks.
Criteria for participating in the study include age 40 or older, male or female patients, and 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.
The main objective of the study is to evaluate in comparison with placebo the efficacy of 2 dose levels of SAR156597 administered subcutaneously for 52 weeks on the lung function of patients with Idiopathic Pulmonary Fibrosis (IPF). Secondary measurements include examining the efficacy and safety of two SAR156597 doses compared to placebo.
There is some controversy about whether inflammation is a cause or consequence of IPF. Hopefully this treatment, which is primarily directed at reducing inflammation, will provide a new alternative for this difficult-to-treat disease.