A Phase II dose ranging efficacy study of anti-thymocyte globulin within 6 weeks of diagnosis of type 1 diabetes.
This clinical study with anti-thymocyte globulin (ATG), supplied by Sanofi, aims to examine the activity and dose schedule of ATG in children and young adults who have recently been diagnosed with type 1 diabetes (T1D) in order to reduce disease progression at the earliest possible time.
The drug ATG will be tested over 12 months in adolescents to adults (12-25 years for now, soon to be followed by 5 to 25 years, n=114).
ATG, given once in a two days infusion regimen, is a drug recently shown to be able to keep the balance between attacking and regulating cells within the immune system, and thereby helping to preserve insulin secretion. Defining the minimal effective dose of ATG treatment is one aim of the study.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115797 (INNODIA) and No 945268 (INNODIA HARVEST).
This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme, “EFPIA”, “JDRF” and “The Leona M. and Harry B. Helmsley Charitable Trust”.
|Start date||24 Nov 2020|
|End date||23 Feb 2025|