Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-01-01 @ 1:24 AM
Study NCT ID:
NCT04661033
Status:
TERMINATED
Last Update Posted:
2024-12-05
First Post:
2020-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Multicenter, Open-label, Non-randomized, Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia
Status:
TERMINATED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study discontinuation based on strategic sponsor decision; not driven by any safety concerns.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives:
* Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA
* Part B: To evaluate the efficacy of the selected dose in adults with wAIHA
Secondary Objectives:
* Part A (Cohorts 2 and 3 only)
* To evaluate the efficacy of isatuximab in adults with wAIHA
* To evaluate the durability of response to isatuximab and time to response
* To evaluate the impact of isatuximab treatment on fatigue
Part B
* To evaluate the safety and tolerability of isatuximab in adults with wAIHA
* To evaluate the durability of response to isatuximab and time to response
* To evaluate the impact of isatuximab treatment on fatigue
Parts A (all Cohorts) and B
* To evaluate the effect of isatuximab on markers of hemolysis
* To characterize the pharmacokinetic profile of isatuximab in adults with wAIHA
* To evaluate the immunogenicity of isatuximab
* Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA
* Part B: To evaluate the efficacy of the selected dose in adults with wAIHA
Secondary Objectives:
* Part A (Cohorts 2 and 3 only)
* To evaluate the efficacy of isatuximab in adults with wAIHA
* To evaluate the durability of response to isatuximab and time to response
* To evaluate the impact of isatuximab treatment on fatigue
Part B
* To evaluate the safety and tolerability of isatuximab in adults with wAIHA
* To evaluate the durability of response to isatuximab and time to response
* To evaluate the impact of isatuximab treatment on fatigue
Parts A (all Cohorts) and B
* To evaluate the effect of isatuximab on markers of hemolysis
* To characterize the pharmacokinetic profile of isatuximab in adults with wAIHA
* To evaluate the immunogenicity of isatuximab
Detailed Description:
28 weeks (including screening)
Study Oversight
Has Oversight DMC:
False
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?: