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

Recruiting Phase 2 Interventional Study
Type 1 Diabetes
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
16 – 45
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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 pro…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * • Age at inclusion between ≥ 16 years old (Tanner 5 pubertal stage) and ≤ 45 years old * Type 1 diabetes according to ADA criteria, with at least 1 positive autoantibody among the following: anti-islet, anti-GAD, anti-IA2, anti-ZnT8 and anti-insulin. * Diagnosis ≤ 3 month…
Contacts

David Klatzmann, MD, Ph.D

01 42 17 74 61

david.klatzmann@sorbonne-universite.fr

CONTACT

Roberta Lorenzon, MD

01 42 17 65 16

roberta.lorenzon@sorbonne-universite.fr

CONTACT