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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210392

Enrollment

Registered

2021-10-27

Start date

2021-12-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cold Agglutinin Disease

Interventions

Drug: sutimlimab (BIVV009) Pharmaceutical Form: solution for injection, Route of Administration: intravenous(iv)

Eligibility

Sex/Gender

All

Inclusion 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 cold agglutinin disease (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

Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - Clinical diagnosis of systemic lupus erythematosus (SLE) or immune complex mediated autoimmune disorders. - Participants who meet recent Rituximab and/or immunosuppressive therapy. - Any of the following medical conditions: a) Active, serious intercurrent illness which will preclude enrolment until recovery is complete. b) 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.

Design outcomes

Primary

Measure	Time frame
1. Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Approximately 1 year ] 2. Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) [ Time Frame: Approximately 1 year ]	—

Contacts

Public ContactUnit Clinical

Sanofi K.K.

clinical-trials-jp@sanofi.com+81-3-6301-3670

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026