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
    Recruiting
  • End date
    Nov 21, 2023
  • participants needed
    23
  • sponsor
    Sanofi
Updated on 23 September 2022

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 on23 September 2022

Eligibility

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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