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A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion

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Trial Profile

A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have 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 CARDINAL
  • 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
  • 12 Dec 2023 Results determining the cost-effectiveness of sutimlimab versus standard-of-care for the transfusion-dependent patient population with primary CAD, presented at the 65th American Society of Hematology Annual Meeting and Exposition

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