Objective ConceptThe discovery of regulatory T cells (Tregs) has revolutionized our understanding of autoimmune diseases. As T1D is caused by the failure of Tregs to block autoimmune destruction of pancreatic ß-cells, Treg stimulation has the potential to stop the process, preserve ß-cells’ insulin secretion, and likewise prevent or delay disease progression and improve clinical outcome for patients.BackgroundLow-dose interleukin-2 (ld-IL2) was recently shown to stimulate Tregs without stimulating effector T cells. In NOD mice, ld-IL2 can prevent and cure T1D. In humans, (i) we showed that ld-IL2 is safe, induces Tregs and is associated with clinical improvement in patients with autoimmune vasculitis; and (ii) we performed a dose-finding study in T1D to define an ultra-low dose IL-2 (uld-IL2) that is well tolerated and induces Tregs’ numbers and functionality.With this strong background – a well defined mechanism of action; proof of concept in NOD mice; proof of principle in a clinical trial with another autoimmune disease; safety and activity/efficacy data in T1D – we propose a phase-II clinical trial testing the efficacy of uld-IL2 for preserving ß-cells.MethodThis will be a double-blind randomised placebo-controlled, age-stratified (6-35 year), multicentre European trial assessing efficacy and safety of uld-IL2 (0.5M IU/m2/day with a maximum of 1 MIU/m2/day for adult patients) in 138 recently-diagnosed T1D patients. Our methodology strictly follows the Immunology of Diabetes Society consensus recommendations and European regulatory guidelines. The primary end-point is the change from baseline of AUC C-peptide during a mixed meal test at 1 year. The trial is precisely and conservatively powered to detect an effect size of d=0.5.ImpactsIf successful, this trial will have profound impacts for the management of patients with recently-diagnosed T1D, their families and EU economy. It will be a milestone towards preventing T1D in people at risk of this increasingly common childhood disease. Fields of science medical and health sciencesclinical medicineendocrinologydiabetesmedical and health sciencesbasic medicineimmunologyautoimmune diseases Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH.2012.2.4.3-2 - Investigator-driven clinical trials for type 1 diabetes research Call for proposal FP7-HEALTH-2012-INNOVATION-1 See other projects for this call Funding Scheme CP-FP - Small or medium-scale focused research project Coordinator ASSISTANCE PUBLIQUE HOPITAUX DE PARIS EU contribution € 2 925 549,60 Address 55 BOULEVARD DIDEROT 75012 Paris France See on map Region Ile-de-France Ile-de-France Val-de-Marne Activity type Research Organisations Administrative Contact Catherine Tostain Desmares (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Participants (6) Sort alphabetically Sort by EU Contribution Expand all Collapse all INSERM TRANSFERT SA France EU contribution € 310 193,00 Address 10 RUE D'ORADOUR-SUR-GLANE - PARISANTE CAMPUS 75015 PARIS See on map Region Ile-de-France Ile-de-France Paris Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Florence Chung (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE Participation ended United Kingdom EU contribution € 3 137,96 Address TRINITY LANE THE OLD SCHOOLS CB2 1TN Cambridge See on map Region East of England East Anglia Cambridgeshire CC Activity type Higher or Secondary Education Establishments Administrative Contact Renata Schaeffer (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data UNIVERSITATSSPITAL BASEL Switzerland EU contribution € 360 000,00 Address HEBELSTRASSE 32 4031 Basel See on map Region Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Stadt Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Administrative Contact Marc Donath (Prof.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data ILTOO PHARMA France EU contribution € 2 040 211,44 Address 14 RUE DES RECULETTES 75013 Paris See on map Region Ile-de-France Ile-de-France Paris Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Jérémie Mariau (Mr.) Links Contact the organisation Opens in new window Total cost No data DEUTSCHES KREBSFORSCHUNGSZENTRUM HEIDELBERG Participation ended Germany EU contribution € 73 571,20 Address IM NEUENHEIMER FELD 280 69120 Heidelberg See on map Region Baden-Württemberg Karlsruhe Heidelberg, Stadtkreis Activity type Research Organisations Administrative Contact Ina Krischek (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data ACADEMISCH ZIEKENHUIS LEIDEN Netherlands EU contribution € 187 336,80 Address ALBINUSDREEF 2 2333 ZA Leiden See on map Region West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek Activity type Higher or Secondary Education Establishments Administrative Contact W.M. Schaap (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data