drugset / Trial / NCT05132127

Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan

NCT05132127 ↗

Phase 3 Completed 7 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

This was a multi-center, single treatment-group, open-label study to provide sutimlimab to the adult participants with cold agglutinin disease (CAD) who had completed the CARDINAL (NCT number: NCT03347396) or CADENZA (NCT number: NCT03347422) 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.

Timeline

Start
2021-11-11
Primary completion
2022-11-15
Completion
2022-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject sutimlimab Monoclonal antibody 6.5 g Intravenous