Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)
Status:
Recruiting
Trial end date:
2023-12-13
Target enrollment:
Participant gender:
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