RecruitingPhase 2NCT05153070

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

Clinical and Biological Responses to Repeated Administration of Low-dose Interleukin-2 in Patients With Type 1 Diabetes and a Residual Insulin Secretion


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

24 participants

Start Date

Sep 21, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two immune-modulating treatments — ciclosporin (an immune-suppressing drug) followed by low-dose IL-2 (a protein that boosts regulatory immune cells) — in people recently diagnosed with Type 1 diabetes. The goal is to slow or stop the immune system's attack on insulin-producing cells in the pancreas. **You may be eligible if...** - You are between 16 and 45 years old and have been diagnosed with Type 1 diabetes within the past 3 months - You have at least one positive diabetes autoantibody (e.g., anti-GAD, anti-islet) - You have not had diabetic ketoacidosis - Your insulin-producing cells are still partially functioning (measured by C-peptide levels) - You are willing to use effective contraception throughout the study **You may NOT be eligible if...** - You have signs of active infection - You have a documented history of clinical autoimmune disease - You have HIV, hepatitis B, or hepatitis C - You have a history of cancer (cured within the past 5 years) - You are pregnant or breastfeeding - You have chronic respiratory or heart disease - You have been on another clinical trial within the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclosporin

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

DRUGILT101

• 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.

DRUGPlacebo

• 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

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NCT05153070


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