TY - JOUR T1 - SAR156597 in idiopathic pulmonary fibrosis: a phase 2, placebo-controlled study (DRI11772) JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.01130-2018 SP - 1801130 AU - Ganesh Raghu AU - Luca Richeldi AU - Bruno Crestani AU - Peter Wung AU - Raphael Bejuit AU - Corinne Esperet AU - Christian Antoni AU - Christina Soubrane Y1 - 2018/01/01 UR - http://erj.ersjournals.com/content/early/2018/09/27/13993003.01130-2018.abstract N2 - A phase 2b trial (NCT02345070) was conducted to evaluate the efficacy and safety of two dose levels/regimens of SAR156597 (a bispecific immunoglobulin G4 antibody that binds and neutralises both circulating interleukin-4 and interleukin-13), in comparison with placebo, administered to patients with idiopathic pulmonary fibrosis (IPF) over 52 weeks.DRI11772 was a multinational, randomised, double-blind, placebo-controlled, phase 2b trial. Patients aged >40 years with a documented diagnosis of IPF received SAR156597 200 mg once every week (QW), SAR156597 200 mg once every 2 weeks (Q2W) or placebo, over 52 weeks. The primary efficacy end-point was absolute change from baseline in percent-predicted forced vital capacity (FVC) at 52 weeks.Of 327 randomised patients, 325 received treatment with placebo (n=109), SAR156597 Q2W (n=108) or SAR156597 QW (n=108). The mean change from baseline in percent-predicted FVC at 52 weeks was –5.8%, –5.2% and –6.3% for the placebo, Q2W and QW arms, respectively (Q2W versus placebo, p=0.59; QW versus placebo, p=0.63). The safety profile observed in the three treatment arms was generally similar, although serious adverse events were more common in the QW arm than in the other arms.The DRI11772 study failed to demonstrate a benefit for SAR156597 in the treatment of IPF.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. Raghu reports other from Sanofi, during the conduct of the study; other from Bellerophan, Boerhinger-Ingelheim, BMS, Flbrogen, Gilead, Nitto, Parata, Promedior, Veracyte, outside the submitted work.Conflict of interest: Dr. Richeldi reports grants and personal fees from InterMune, personal fees from Medimmune, personal fees from Biogen, personal fees from Sanofi-Aventis, personal fees from Roche, personal fees from Takeda, personal fees from ImmuneWorks, personal fees from Shionogi, personal fees from Boehringer Ingelheim, personal fees from Pliants Therapeutics, personal fees from Cipla, outside the submitted work.Conflict of interest: Dr. Crestani reports personal fees and other from Aventis, grants, personal fees and non-financial support from Boehringer Ingelheim, grants from CARDIF, grants from LVL, personal fees and non-financial support from Astra Zeneca, grants and non-financial support from Medlmmune, grants, personal fees and non-financial support from Roche, outside the submitted work.Conflict of interest: Dr. Wung has nothing to disclose.Conflict of interest: Dr. Bejuit reports personal fees from SANOFI, during the conduct of the study; personal fees from sanofi, outside the submitted work.Conflict of interest: Corinne EsperetConflict of interest: Dr. Antoni reports personal fees from SANOFI, during the conduct of the study; personal fees from sanofi, outside the submitted work.Conflict of interest: Christina Soubrane. ER -