Trial Outcomes & Findings for Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan (NCT NCT05132127)
NCT ID: NCT05132127
Last Updated: 2025-09-15
Results Overview
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).
COMPLETED
PHASE3
7 participants
From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
2025-09-15
Participant Flow
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.
Per protocol, enrolled participants were planned to receive sutimlimab based on their baseline body weight as: 6.5 grams for baseline body weight of greater than or equal to (\>=) 39 kilograms (kg) to less than (\<) 75 kg or 7.5 grams for baseline body weight of \>= 75 kg. As no participant had a Baseline body weight \>= 75 kg, per the study protocol, 7.5 grams dose was not administered.
Participant milestones
| Measure |
Sutimlimab
Participants with body weight \>= 39 kg to \< 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.
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|---|---|
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Overall Study
STARTED
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7
|
|
Overall Study
COMPLETED
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6
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Sutimlimab
Participants with body weight \>= 39 kg to \< 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.
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|---|---|
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Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
Baseline characteristics by cohort
| Measure |
Sutimlimab
n=7 Participants
Participants with body weight \>= 39 kg to \< 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 IV infusion on Day 0, Day 7, Day 21 and thereafter every 2 weeks (maximum duration: 49 weeks) in the current study.
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|---|---|
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Age, Continuous
|
69.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
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|
Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
White
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)Population: Analysis was performed on safety population.
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).
Outcome measures
| Measure |
Sutimlimab
n=7 Participants
Participants with body weight \>= 39 kg to \< 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 IV infusion on Day 0, Day 7, Day 21 and thereafter every 2 weeks (maximum duration: 49 weeks) in the current study.
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|---|---|
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
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1 Participants
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PRIMARY outcome
Timeframe: From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)Population: Analysis was performed on safety population.
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.
Outcome measures
| Measure |
Sutimlimab
n=7 Participants
Participants with body weight \>= 39 kg to \< 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 IV infusion on Day 0, Day 7, Day 21 and thereafter every 2 weeks (maximum duration: 49 weeks) in the current study.
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|---|---|
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Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)
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0 Participants
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Adverse Events
Sutimlimab
Serious adverse events
| Measure |
Sutimlimab
n=7 participants at risk
Participants with body weight \>= 39 kg to \< 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 IV infusion on Day 0, Day 7, Day 21 and thereafter every 2 weeks (maximum duration: 49 weeks) in the current study.
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|---|---|
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Infections and infestations
Spontaneous Bacterial Peritonitis
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Cholangitis Acute
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
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|
Renal and urinary disorders
Chronic Kidney Disease
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
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Other adverse events
| Measure |
Sutimlimab
n=7 participants at risk
Participants with body weight \>= 39 kg to \< 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 IV infusion on Day 0, Day 7, Day 21 and thereafter every 2 weeks (maximum duration: 49 weeks) in the current study.
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|---|---|
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Infections and infestations
Cystitis
|
14.3%
1/7 • Number of events 2 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Infections and infestations
Gingivitis
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Infections and infestations
Rhinitis
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14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
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|
Infections and infestations
Skin Candida
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
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Infections and infestations
Urinary Tract Infection
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14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
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Blood and lymphatic system disorders
Iron Deficiency Anaemia
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14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Endocrine disorders
Hypothyroidism
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14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Psychiatric disorders
Insomnia
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14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Psychiatric disorders
Restlessness
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14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Number of events 9 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Lip Haemorrhage
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
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Skin and subcutaneous tissue disorders
Epidermolysis
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14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
42.9%
3/7 • Number of events 3 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
General disorders
Pyrexia
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28.6%
2/7 • Number of events 3 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
General disorders
Vaccination Site Pain
|
14.3%
1/7 • Number of events 2 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Investigations
Blood Immunoglobulin M Increased
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Investigations
Blood Iron Decreased
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Investigations
Blood Pressure Increased
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Investigations
C-Reactive Protein Increased
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
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Investigations
Cytomegalovirus Test Positive
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
14.3%
1/7 • Number of events 1 • From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Analysis was performed on safety population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER