Safety and effectiveness of SAR156597 in the treatment of IPF
Research type
Research Study
Full title
Efficacy and safety of SAR156597 in the treatment of Idiopathic Pulmonary Fibrosis (IPF): A randomized, double-blind, placebo-controlled, 52-week dose-ranging study
IRAS ID
179571
Contact name
Tony Maher
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & développement
Eudract number
2014-003933-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
SAR156597 is a type of drug called monoclonal antibody (a type of protein) for patients with Idiopathic Pulmonary Fibrosis (IPF). Patients with IPF, a chronic lung disease, have a median survival of approximately 3 years. The cause of the disease is not known – but, increases in levels of certain proteins produced by cells of the immune system have been linked to the development of the disease. SAR156597 blocks those proteins – therefore it is hoped that this drug will delay the development of the disease.
The purpose of this study is to find out if the drug improves the lung function of patients with IPF, if it slows down the disease progression, what the side effects are and what the blood levels of the drug are. The patients' immune response to the drug, the effect of the drug on circulating biomarkers and the effect of the drug on patients' quality of life will also be assessed. If patients consent, their DNA (genetic material) and how it affects the way they react to and handle the drug, and non-genetic analysis related to IPF, may also be studied.
The study will be done in about 300 patients with IPF. 16 of those patients are planned to be recruited in the UK. Participants will receive a subcutaneous injection of the drug in their abdomen. They’ll receive 1 injection every week for 1 year. Eight of the injections will be given at the study site. Participants will be able to choose if they’d like to receive the other injections at the clinic or at home. Home visits and dosing will be done by a trained healthcare professional.
A pharmaceutical company (Sanofi) is sponsoring this study.
The study is planned to take part in 4 NHS centres in England.
REC name
London - London Bridge Research Ethics Committee
REC reference
15/LO/0861
Date of REC Opinion
29 Jul 2015
REC opinion
Further Information Favourable Opinion