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

Study acronym: DF-IL2-REP
StatusRecruiting
PhasePhase 2
Started2022-09-21
View on ClinicalTrials.gov ↗
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.

Amendment history 2 changes detected by DataLookout

2026-09-10
critical
Primary completion pushed: 2026-04-21 → 2027-11-29
2026-09-10
minor
Completion moved earlier: 2028-04-21 → 2027-11-29
Trial Details
NCT Number NCT05153070
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: Iltoo Pharma
Conditions Type 1 Diabetes
Enrollment 24 participants
Start Date 2022-09-21
Primary Completion 2027-11-29 (estimated)
Study Completion 2027-11-29 (estimated)
Updated on ClinicalTrials.gov 2026-09-09