Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05153070
Status:
RECRUITING
Last Update Posted:
2023-08-14
First Post:
2021-04-16
Brief Title:
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DF-IL2-REP
Brief 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
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
Detailed Description:
Primary Objective
Tregs response profile after 4 administrations of 1MIUday of IL-2 Day 63-66 in patients with recently diagnosed type 1 diabetes who have been treated with ciclosporin for 2 months
Primary assessment criterion
Change in Tregs values at D67 compared to D63 post-ciclosporin values
Secondary objectives and secondary assessment criteria
Change in residual insulin secretion
AUC plasma C-peptide concentration after a mixed meal tolerance test at Month 6 Day 179 Month 12 Day 361 and after treatment discontinuation at Month 18 Day 536 and Month 24 Day 719 compared to baseline
Insulin requirement HbA1c dosage and IDAA1c score at Month 3 Day 88 Month 6 Day 179 Month 9 Day 270 Month 12 Day 361 and after treatment discontinuation at Month 18 Day 536 and Month 24 Day 719 compared to baseline
Change in Tregs values at Month 3 Day 88 Month 6 Day 179 Month 9 Day 270 Month 12 Day 361 and after treatment discontinuation at Month 18 Day 536 and Month 24 Day 719 compared to baseline and post-ciclosporin values Day 63
Ciclosporin and ILT-101placebo compliance
Tolerance
Experimental design
This is a monocentric randomized placebo controlled double-blind trial in parallel-groups evaluating a treatment by cyclosporine 7mgkgday during 2 months followed by ILT-101placebo 1 MIU daily for 5 days and 1 MIU every week during 10 months
Population involved
Male or female aged between 16 and 35 years with recent diagnosis of type 1 diabetes 3 months
Number of subjects 24 Inclusion period 12 months Duration of patient participation 24 months treatment period 12 months follow-up period 12months Total duration of the study 37 months
Tregs response profile after 4 administrations of 1MIUday of IL-2 Day 63-66 in patients with recently diagnosed type 1 diabetes who have been treated with ciclosporin for 2 months
Primary assessment criterion
Change in Tregs values at D67 compared to D63 post-ciclosporin values
Secondary objectives and secondary assessment criteria
Change in residual insulin secretion
AUC plasma C-peptide concentration after a mixed meal tolerance test at Month 6 Day 179 Month 12 Day 361 and after treatment discontinuation at Month 18 Day 536 and Month 24 Day 719 compared to baseline
Insulin requirement HbA1c dosage and IDAA1c score at Month 3 Day 88 Month 6 Day 179 Month 9 Day 270 Month 12 Day 361 and after treatment discontinuation at Month 18 Day 536 and Month 24 Day 719 compared to baseline
Change in Tregs values at Month 3 Day 88 Month 6 Day 179 Month 9 Day 270 Month 12 Day 361 and after treatment discontinuation at Month 18 Day 536 and Month 24 Day 719 compared to baseline and post-ciclosporin values Day 63
Ciclosporin and ILT-101placebo compliance
Tolerance
Experimental design
This is a monocentric randomized placebo controlled double-blind trial in parallel-groups evaluating a treatment by cyclosporine 7mgkgday during 2 months followed by ILT-101placebo 1 MIU daily for 5 days and 1 MIU every week during 10 months
Population involved
Male or female aged between 16 and 35 years with recent diagnosis of type 1 diabetes 3 months
Number of subjects 24 Inclusion period 12 months Duration of patient participation 24 months treatment period 12 months follow-up period 12months Total duration of the study 37 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None