An Open-label Study for Sutimlimab in Participants With Cold Agglutinin Disease (CAD) Who Have Completed the CARDINAL Study (BIVV009-03/EFC16215, Part B) or CADENZA Study (BIVV009-04/EFC16216, Part B) in Japan

  • STATUS
    Not Recruiting
  • days left to enroll
    30
  • participants needed
    7
  • sponsor
    Sanofi
Updated on 23 September 2022

Summary

This is a multi-center, single treatment-group, open-label study to provide sutimlimab to the adult participants with cold agglutinin disease (CAD) who have completed the CARDINAL or CADENZA studies, and benefitted from sutimlimab treatment in Japan.

• Study and treatment duration: the period between the participant's completion of the CARDINAL and CADENZA studies and sutimlimab or other appropriate CAD therapy becoming commercially available to participants in Japan.

Description

The period between screening/baseline visit (upon the participant's completion* of the CARDINAL and CADENZA studies) and end of treatment with sutimlimab in this study is determined by sutimlimab or other appropriate CAD therapy becoming commercially available to participants in Japan.

Details
Condition Cold Agglutinin Disease
Treatment Sutimlimab
Clinical Study IdentifierNCT05132127
SponsorSanofi
Last Modified on23 September 2022

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