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

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.

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Key information

Conditions

Cold Agglutinin Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Autoimmune Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number 3920005, Ishikawa, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

--Participant must be adults.

Participants who had been enrolled in and had completed Part B of CARDINAL or CADENZA study.
Participants who had ongoing diagnosis of CAD.
Participants who continued 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 had acceptable benefit/risk profile.
Participant who had acceptable infection risk.
Participants who had no available appropriate alternative therapy for CAD.
Body weight >= 39 kg.
Gave signed informed consent.

Exclusion criteria

--Clinical diagnosis of systemic lupus erythematosus or immune complex-mediated autoimmune disorders.

Participants who met recent Rituximab and/or immunosuppressive therapy.
Any of the following medical conditions:

Active, serious intercurrent illness which precluded enrolment until recovery was complete.
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, contraindicated participation in the study.

Treatment and study plan

Sutimlimab

Drug

Pharmaceutical form: solution for injection Route of administration: intravenous (IV)

Primary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Time frame: From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)

An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study intervention and did not necessarily had to have a causal relationship with the treatment. Serious adverse events (SAEs) were defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, was a congenital anomaly/birth defect, suspected transmission of any infectious agent via an authorized medicinal product, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the treatment-emergent period (from first dose of study intervention up to 9 weeks after the last dose of study intervention in the current study).
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)

Time frame: From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)

An AE was defined as any untoward medical occurrence in a participant who received study intervention and did not necessarily had to have a causal relationship with the treatment. AESIs were AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Nov 24, 2021
Registry last updated: Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed