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

• Status: Not yet recruiting
• Trial end date: 2022-08-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

Inclusion Criteria:

--Participant must be adults.

• Participants who have been enrolled in, and has completed Part B of CARDINAL or CADENZA study

• Participants who have ongoing diagnosis of CAD

• Participants who continue to require treatment for CAD upon completion of participation in the previous study evidenced by return of CAD-related symptoms of anemia and/or deterioration on markers of hemolysis after the end of study visit following the 9-week safety follow up period. (9-week follow up period).

• Participants who have acceptable benefit/risk profile

• Participant who has acceptable infection risk

• Participants who have no available appropriate alternative therapy for CAD

• Body weight of ≥39 kg

• Giving signed informed consent - - - -

Exclusion Criteria:

--Clinical diagnosis of systemic SLE or immune complex mediated autoimmune disorders

• Participants who meet recent Rituximab and/or immunosuppressive therapy

• Any of the following medical conditions:

1. Active, serious intercurrent illness which will preclude enrolment until recovery is complete.

2. Pregnancy or breast-feeding

• End of Study visit in CARDINAL or CADENZA took place more than 3 months before baseline visit in this study.

• Hypersensitivity reactions to sutimlimab or components thereof, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study