SAR156597 in idiopathic pulmonary fibrosis: A phase 2 placebo-controlled study (DRI11772)

Ganesh Raghu, Luca Richeldi, Bruno Crestani, Peter Wung, Raphael Bejuit, Corinne Esperet, Christian Antoni, Christina Soubrane

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Abstract

A phase 2b trial (NCT02345070) was conducted to evaluate the efficacy and safety of two dose levels/regimens of SAR156597 (a bispecific IgG4 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 forced vital capacity (FVC) % predicted 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 FVC % pred 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 benefit of SAR156597 in the treatment of IPF.

Original languageEnglish
Article number1801130
JournalEuropean Respiratory Journal
Volume52
Issue number6
DOIs
Publication statusPublished - Dec 1 2018

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Idiopathic Pulmonary Fibrosis
Placebos
Vital Capacity
Bispecific Antibodies
Safety
Interleukin-13
Interleukin-4
Therapeutics
Immunoglobulin G

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

SAR156597 in idiopathic pulmonary fibrosis : A phase 2 placebo-controlled study (DRI11772). / Raghu, Ganesh; Richeldi, Luca; Crestani, Bruno; Wung, Peter; Bejuit, Raphael; Esperet, Corinne; Antoni, Christian; Soubrane, Christina.

In: European Respiratory Journal, Vol. 52, No. 6, 1801130, 01.12.2018.

Research output: Contribution to journalArticle

Raghu, G, Richeldi, L, Crestani, B, Wung, P, Bejuit, R, Esperet, C, Antoni, C & Soubrane, C 2018, 'SAR156597 in idiopathic pulmonary fibrosis: A phase 2 placebo-controlled study (DRI11772)', European Respiratory Journal, vol. 52, no. 6, 1801130. https://doi.org/10.1183/13993003.01130-2018
Raghu, Ganesh ; Richeldi, Luca ; Crestani, Bruno ; Wung, Peter ; Bejuit, Raphael ; Esperet, Corinne ; Antoni, Christian ; Soubrane, Christina. / SAR156597 in idiopathic pulmonary fibrosis : A phase 2 placebo-controlled study (DRI11772). In: European Respiratory Journal. 2018 ; Vol. 52, No. 6.
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