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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: 17 Dec 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

    • 01 Dec 2024 Results reporting long-term safety and efficacy data of sutimlimab in Japanese patients with CAD who completed the phase 3 CARDINAL/CADENZA study and continued in the Japan OLE study published in the International Journal of Hematology
    • 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.

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