Ignite Creation Date:
2024-05-06 @ 1:37 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04077684
Status:
RECRUITING
Last Update Posted:
2023-10-12
First Post:
2019-09-01
Brief Title:
Efficacy and Safety of Low-dose IL-2 in Patients With SLE a Multicenter Randomised Placebo-controlled Trial
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Efficacy and Safety of Low-dose Interleukin-2 in Patients With Systemic Lupus Erythematosus a Multicenter Randomised Placebo-controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-10
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:
None
Brief Summary:
The management of active systemic lupus erythematosus SLE is challenging due to the heterogeneous nature of the disease and lack of specific treatment Current treatment regimens mainly rely on corticosteroids and immunosuppressive agents which are associated with substantial adverse effects including various infections Therefore there is an unmet need for new therapies with better efficacy and less adverse effects
Defective IL-2 production contributes to the unbalanced immune system in SLE Previous short term open-labelled trials showed that low-dose IL-2 was efficient and tolerated in active SLE It was suggested that low-dose IL-2 treatment promoted regulatory T cells Treg and inhibited T helper 17 cells Th17 and follicular helper T cells Tfh The immunological rebalancing was associated with the induction of remission in SLE patients
To establish that which low doses of IL-2 would be more efficacious and safe in active SLE we carried out a multi-center randomized double-blind placebo-controlled trial of three doses of IL2 02 MIU 05 MIU or 1 MIU versus placebo
Defective IL-2 production contributes to the unbalanced immune system in SLE Previous short term open-labelled trials showed that low-dose IL-2 was efficient and tolerated in active SLE It was suggested that low-dose IL-2 treatment promoted regulatory T cells Treg and inhibited T helper 17 cells Th17 and follicular helper T cells Tfh The immunological rebalancing was associated with the induction of remission in SLE patients
To establish that which low doses of IL-2 would be more efficacious and safe in active SLE we carried out a multi-center randomized double-blind placebo-controlled trial of three doses of IL2 02 MIU 05 MIU or 1 MIU versus placebo
Detailed Description:
Active SLE patients at 18 to 75 years of age were enrolled Patients were randomly assigned in a 1111 ratio to one of the four arms placebo or IL-2 at 02 MIU 05 MIU or 1 MIU in the study IL-2 02 MIU 05 MIU or 1 MIU or placebo was administered subcutaneously every other day for the first 12 weeks and then was adjusted to once a week for the second 12 weeks Follow-up visits occurred on weeks 4 8121620 and 24 The end points were safety and clinical and immunologic response
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