NCT05132127

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

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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 was determined by sutimlimab or other appropriate CAD therapy becoming commercially available to participants in Japan.

Conditions

• Cold Agglutinin Disease

Interventions

Type	Name	Description
DRUG	sutimlimab	Pharmaceutical form: solution for injection Route of administration: intravenous (IV)

Timeline

• Start date: 2021-11-11
• Primary completion: 2022-11-15
• Completion: 2022-11-15
• First posted: 2021-11-24
• Last updated: 2025-09-15
• Results posted: 2023-10-03

Locations

5 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study