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Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
Type 1 diabetes (T1D) is caused by the destruction of insulin-producing cells by effector T cells (Teffs), due to a deficiency of regulatory T cells (Tregs). Ciclosporin effectively blocks the Teffs and controls diabetes, but cannot be considered as a long-term treatment. Low-dose interleukin-2 (ld IL-2) activates and expands Tregs in humans. Hence, Ld IL-2 in patients in whom the autoimmune process was blocked early by a short treatment (2 months) of cyclosporine should restore immune homeostasis and maintain some insulin production over the long term.
Official title: Clinical and Biological Responses to Repeated Administration of Low-dose Interleukin-2 in Patients With Type 1 Diabetes and a Residual Insulin Secretion
Key Details
Gender
All
Age Range
16 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2022-09-21
Completion Date
2028-04-21
Last Updated
2025-06-27
Healthy Volunteers
No
Conditions
Interventions
Cyclosporin
• Ciclosporin: 5mg/kg, twice a day, oral, between Day 1 and Day 60
ILT101
• ILT-101: 1MIU/day in a volume of 1 ml; subcutaneous injection every day during 5 consecutive days and then every week between Day 63 and Day 354.
Placebo
• Placebo with an identical formulation and regimen of injections i.e. Subcutaneous injection every day (5 consecutive days) then then every week between Day 63 and Day 354.
Locations (1)
Lorenzon Roberta
Paris, France