A Phase 3 interventional study of sutimlimab in Cold Agglutinin Disease, sponsored by Sanofi. Completed at 5 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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.
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.
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This study's enrollment of 7 is below the median of 24 across 73 interventional studies indexed under Anemia, Hemolytic, Autoimmune.
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--Participant must be adults.
Exclusion Criteria:
--Clinical diagnosis of systemic lupus erythematosus or immune complex-mediated autoimmune disorders.
Any of the following medical conditions:
Participants with body weight greater than or equal to (\>=) 39 kilograms (kg) to less than (\<) 75 kg and who had completed Part B of CARDINAL or CADENZA study were enrolled in the current study and received sutimlimab (BIVV009) 6.5 grams as intravenous (IV) infusion on Day 0, Day 7, Day 21 and thereafter every 2 weeks (maximum duration: 49 weeks) in the current study.
Drug: sutimlimab
Pharmaceutical form: solution for injection Route of administration: intravenous (IV)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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).
Time frame: From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)
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.
Time frame: From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
The study was conducted at 5 active sites in Japan. A total of 7 participants were enrolled from 11 November 2021 to 07 December 2021. Participants with cold agglutinin disease (CAD) and who had completed Part B of CARDINAL (NCT03347396) or CADENZA (NCT03347422) study and benefitted from sutimlimab treatment were enrolled in the current study.
| Milestone | Sutimlimab |
|---|---|
| Started | 7 |
| Completed | 6 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
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).
| Participants | Sutimlimab |
|---|---|
| TEAEs | 7 |
| TESAEs | 1 |
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.
| Participants | Sutimlimab |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) | 0 |
Collected over From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sutimlimab | 1/7 (14.3%) | 1/7 (14.3%) | 7/7 (100%) |
| Event | Sutimlimab |
|---|---|
| Spontaneous Bacterial PeritonitisInfections and infestations | 1/7 |
| Cholangitis AcuteHepatobiliary disorders | 1/7 |
| Chronic Kidney DiseaseRenal and urinary disorders | 1/7 |
| Event | Sutimlimab |
|---|---|
| Back PainMusculoskeletal and connective tissue disorders | 3/7 |
| PyrexiaGeneral disorders | 2/7 |
| CystitisInfections and infestations | 1/7 |
| GingivitisInfections and infestations | 1/7 |
| NasopharyngitisInfections and infestations | 1/7 |
| RhinitisInfections and infestations | 1/7 |
| Skin CandidaInfections and infestations | 1/7 |
| Urinary Tract InfectionInfections and infestations | 1/7 |
| Iron Deficiency AnaemiaBlood and lymphatic system disorders | 1/7 |
| HypothyroidismEndocrine disorders | 1/7 |
Analysis was performed on safety population which included all enrolled participants who took at least 1 dose of study intervention.
| Age, Continuous(years) | Sutimlimab |
|---|---|
| Mean | 69.3 ± 12.8 |
| Sex: Female, Male(Participants) | Sutimlimab |
|---|---|
| Female | 5 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Sutimlimab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 7 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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