Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05132127
Status:
COMPLETED
Last Update Posted:
2023-10-03
First Post:
2021-11-11
Brief Title:
Sutimlimab BIVV009 for the Adult Participants With Cold Agglutinin Disease CAD Who Have Completed Phase 3 Studies CARDINAL or CADENZA in Japan
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
An Open-label Study for Sutimlimab in Participants With Cold Agglutinin Disease CAD Who Have Completed the CARDINAL Study BIVV009-03EFC16215 Part B or CADENZA Study BIVV009-04EFC16216 Part B in Japan
Status:
COMPLETED
Status Verified Date:
2023-09
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:
This was a multi-center single treatment-group open-label study to provide sutimlimab to the adult participants with cold agglutinin disease CAD who had completed the CARDINAL NCT number NCT03347396 or CADENZA NCT number NCT03347422 studies and benefitted from sutimlimab treatment in Japan
Study and treatment duration the period between the participants completion of the CARDINAL and CADENZA studies and sutimlimab or other appropriate CAD therapy becoming commercially available to participants in Japan
Study and treatment duration the period between the participants completion of the CARDINAL and CADENZA studies and sutimlimab or other appropriate CAD therapy becoming commercially available to participants in Japan
Detailed Description:
The period between screeningbaseline visit upon the participants completion of the CARDINAL and CADENZA studies and end of treatment with sutimlimab in this study was determined by sutimlimab or other appropriate CAD therapy becoming commercially available to participants in Japan
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1266-5421 | REGISTRY | ICTRP | None |