Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04669600
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2020-12-09
Brief Title:
A Phase 2a Study Evaluating BIVV020 in Adults With PersistentChronic Immune Thrombocytopenia ITP
Sponsor:
Bioverativ a Sanofi company
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Phase 2a Open-label Non-randomized Study Evaluating the Efficacy Safety and Tolerability of BIVV020 in Adults With PersistentChronic Immune Thrombocytopenia ITP
Status:
COMPLETED
Status Verified Date:
2024-02
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:
Primary Objective
- To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistentchronic immune thrombocytopenia ITP
Secondary Objectives
To assess the safety and tolerability of BIVV020
To assess the pharmacokinetics of BIVV020
To assess the response rate of treatment with BIVV020
To assess the time to response
To assess the effect of treatment with BIVV020 on the requirement for rescue ITP therapy
To assess the immunogenicity of BIVV020
- To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistentchronic immune thrombocytopenia ITP
Secondary Objectives
To assess the safety and tolerability of BIVV020
To assess the pharmacokinetics of BIVV020
To assess the response rate of treatment with BIVV020
To assess the time to response
To assess the effect of treatment with BIVV020 on the requirement for rescue ITP therapy
To assess the immunogenicity of BIVV020
Detailed Description:
Study duration
Screening period up to 56 days
Transition period between last sutimlimab dose and first dose of BIVV020 for participants who were previously receiving sutimlimab 14 days included as part of the 56-day Screening period Treatment duration Minimum 52 weeks
Visit frequency
Day 1
Day 4
Weeks 1 to 6 Weekly
Weeks 7 to 12 Every other week
Weeks 13 to 24 Every 4 weeks
Weeks 25 At least every 8 weeks
End of Study visit 22 weeks after the last dose of BIVV020
Screening period up to 56 days
Transition period between last sutimlimab dose and first dose of BIVV020 for participants who were previously receiving sutimlimab 14 days included as part of the 56-day Screening period Treatment duration Minimum 52 weeks
Visit frequency
Day 1
Day 4
Weeks 1 to 6 Weekly
Weeks 7 to 12 Every other week
Weeks 13 to 24 Every 4 weeks
Weeks 25 At least every 8 weeks
End of Study visit 22 weeks after the last dose of BIVV020
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 |
|---|---|---|---|
| U1111-1253-2343 | OTHER | UTN | None |
| 2020-004162-18 | EUDRACT_NUMBER | None | None |