Ignite Creation Date:
2024-07-17 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500702
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
A Study to Evaluate the Efficacy and Safety of Frexalimab SAR442970 or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Parallel-group Treatment Phase 2a Multicenter Randomized Double-blind Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab SAR442970 and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis FSGS or Minimal Change Disease MCD
Status:
RECRUITING
Status Verified Date:
2024-10
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:
RESULT
Brief Summary:
This is a parallel Phase 2a double-blind 6-arm study for the treatment of primary focal segmental glomerulosclerosis FSGS or primary minimal change disease MCD
The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab SAR442970 or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years
Study details for each participant include
The study duration will be up to 76 weeks The treatment duration will be 24 weeks There will be up to 18 visits
The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab SAR442970 or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years
Study details for each participant include
The study duration will be up to 76 weeks The treatment duration will be 24 weeks There will be up to 18 visits
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-511775-15 | REGISTRY | None | None |
| U1111-1301-2676 | REGISTRY | None | None |