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RECRUITING
NCT05153070
PHASE2

Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

DRUG

Cyclosporin

• Ciclosporin: 5mg/kg, twice a day, oral, between Day 1 and Day 60

DRUG

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.

DRUG

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