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A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jan 2024

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At a glance

  • Drugs Sutimlimab (Primary)
  • Indications Autoimmune haemolytic anaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms CADENZA
  • Sponsors Bioverativ

    • Most Recent Events

    • 12 Dec 2023 Results of Post-Hoc Analysis Part A and B of the Phase 3 Cardinal(n=24) and Cadenza(n=42), presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 15 Jun 2023 Results of post hoc analysis (n=61) assessing the concomitant use of COVID-19 vaccines and sutimlimab in patients with cold agglutinin disease from the open-label extension of the CADENZA and CARDINAL studies, presented at the 28th Congress of the European Haematology Association.
    • 15 Jun 2023 Results of post hoc analysis assessing the baseline serum markers are associated with response as defined by the primary endpoints of the CARDINAL (n=22) and CADENZA (n=19) studies, presented at the 28th Congress of the European Haematology Association.

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