A randomised, single-blind, placebo-controlled, dose-finding safety and tolerability study of the anti-CD3 monoclonal antibody otelixizumab in new-onset type 1 diabetes

Bart Keymeulen 1,2, André van Maurik 3, Dave Inman 3, João Oliveira 4, Rene McLaughlin 5, Rachel M Gittelman 6, Bart O Roep 7,8, Pieter Gillard 9, Robert Hilbrands 10,11, Frans Gorus 10,11, Chantal Mathieu 9, Ursule Van de Velde 10,11, Nicolas Wisniacki 3, Antonella Napolitano 12; 1 Academic Hospital and Diabetes Research Center, Vrije Universiteit Brussel, Brussels, Belgium. bart.keymeulen@vub.be. 2 Belgian Diabetes Registry, Brussels, Belgium. bart.keymeulen@vub.be. 3 GlaxoSmithKline Medicines Research Centre, Stevenage, UK. 4 GlaxoSmithKline, Global Clinical Operations, Cambridge, UK. 5 Department of Immunology and Blood Transfusion, Leiden University Medical Center, Leiden, the Netherlands. 6 Adaptive Biotechnologies, Seattle, WA, USA. 7 Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands. 8 Department of Diabetes Immunology, Diabetes & Metabolism Research Institute, Beckman Research Institute at the City of Hope, Duarte, CA, USA. 9 Department of Endocrinology, University Hospitals Leuven-KUL, Leuven, Belgium. 10 Academic Hospital and Diabetes Research Center, Vrije Universiteit Brussel, Brussels, Belgium. 11 Belgian Diabetes Registry, Brussels, Belgium. 12 GlaxoSmithKline Medicines Research Centre, Stevenage, UK. Antonella.2.napolitano@gsk.com.