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
    Not Recruiting
  • End date
    Jul 22, 2024
  • participants needed
    23
  • sponsor
    Sanofi
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Updated on 29 July 2023

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

Description

28 weeks (including screening)

Details
Condition Warm Autoimmune Hemolytic Anemia (wAIHA)
Treatment Montelukast, Acetaminophen, Diphenhydramine, Famotidine, isatuximab SAR650984
Clinical Study IdentifierNCT04661033
SponsorSanofi
Last Modified on29 July 2023

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