DIABIL-2
Ultra-low dose of IL-2 for the treatment of recently diagnosed type 1 diabetes
| Coordinatore | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Organization address
address: 3 Avenue Victoria contact info |
| Nazionalità Coordinatore | France [FR] |
| Sito del progetto | http://www.diabil-2.eu/ |
| Totale costo | 7˙608˙534 € |
| EC contributo | 5˙900˙000 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2012-INNOVATION-1 |
| Funding Scheme | CP-FP |
| Anno di inizio | 2012 |
| Periodo (anno-mese-giorno) | 2012-10-01 - 2016-09-30 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Organization address
address: 3 Avenue Victoria contact info |
FR (PARIS) | coordinator | 2˙892˙300.00 |
| 2 |
ILTOO PHARMA SAS
Organization address
address: RUE DU FAUBOURG SAINT-ANTOINE 212 contact info |
FR (PARIS) | participant | 1˙513˙000.00 |
| 3 |
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE
Organization address
address: The Old Schools, Trinity Lane contact info |
UK (CAMBRIDGE) | participant | 470˙900.00 |
| 4 |
UNIVERSITAETSSPITAL BASEL
Organization address
address: HEBELSTRASSE 32 contact info |
CH (BASEL) | participant | 360˙000.00 |
| 5 |
DEUTSCHES KREBSFORSCHUNGSZENTRUM
Organization address
address: Im Neuenheimer Feld 280 contact info |
DE (HEIDELBERG) | participant | 350˙000.00 |
| 6 |
INSERM - TRANSFERT SA
Organization address
address: Rue Watt 7 contact info |
FR (PARIS) | participant | 313˙800.00 |
Mappa
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Obiettivo del progetto (Objective)
'Concept The 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. Background Low-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. Method This will be a double-blind randomised placebo-controlled age-stratified (7-35 year) multicentre European trial assessing efficacy and safety of uld-IL2 (5x10e5 IU/m2/day) in 200 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. Impacts If 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.'
Introduzione (Teaser)
Diabetes is a metabolic disorder of increasing prevalence in modern society. Finding ways to prevent or cure this disease presents a significant medical challenge.