Ignite Creation Date:
2024-05-06 @ 4:00 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02424396
Status:
COMPLETED
Last Update Posted:
2020-11-09
First Post:
2015-04-20
Brief Title:
Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis Multicentric Randomized Study
Status:
COMPLETED
Status Verified Date:
2020-11
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:
MS-IL2
Brief Summary:
Interleukin-2 IL-2 was initially discovered and used as a stimulator of effector T lymphocytes Teffs but is now viewed as a very promising immunoregulatory drug having the capacity to stimulate regulatory T cells Tregs At low dose Il-2 tips the TregTeff balance towards Tregs Recently it has been shown that Tregs of MS patients have reduced proliferative potential MS-IL2 will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a Relapsing-Remitting Multiple Sclerosis RRMS with the aim to stimulate Treg and define potential clinical benefits
Detailed Description:
In MS-IL2 30 RRMS patients will be treated in a randomized double-blind placebo controlled clinical trial IL-2 will be administered first as an induction course of IL-2 or placebo each day for 5 days followed by a maintenance course at the same dose or placebo every two weeks over 6 months
The primary efficacy criteria will be the change from baseline in Treg at day-5 which is indicative of the biological response to IL-2
The secondary efficacy criteria will be i the maintenance of regulatory T cells during the 6 months of treatment with IL-2 vs placebo and ii the stabilization or regression of the disease as determined by disease activity parameters assessed by MRI cumulative number of new lesions in T1 enhanced by gadolinium after 6 months in the groups treated with IL-2 compared to placebo
Expected impact MS-IL2 will define which patient respond to IL2 and which doses prevent relapses in RRMS In addition the deep phenomics studies will further provide the foundation for a clinical phase II to define clinical efficacy
The primary efficacy criteria will be the change from baseline in Treg at day-5 which is indicative of the biological response to IL-2
The secondary efficacy criteria will be i the maintenance of regulatory T cells during the 6 months of treatment with IL-2 vs placebo and ii the stabilization or regression of the disease as determined by disease activity parameters assessed by MRI cumulative number of new lesions in T1 enhanced by gadolinium after 6 months in the groups treated with IL-2 compared to placebo
Expected impact MS-IL2 will define which patient respond to IL2 and which doses prevent relapses in RRMS In addition the deep phenomics studies will further provide the foundation for a clinical phase II to define clinical efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-000088-82 | OTHER | EudractCT | None |