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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1266-5421 | Registry Identifier | ICTRP |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sutimlimab | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sutimlimab | Drug | Pharmaceutical form: solution for injection Route of administration: intravenous (IV) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks) |
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Inclusion Criteria:
--Participant must be adults.
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 3920005 | Ishikawa | 920-8530 | Japan | |||
| Investigational Site Number 3920004 |
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| Label | URL |
|---|---|
| LTS17352 Plain Language Results Summary | View source |
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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
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2021 | Aug 2, 2023 |
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| Kanagawa |
| 259-1193 |
| Japan |
| Investigational Site Number 3920003 | Osaka | 565-0871 | Japan |
| Investigational Site Number 3920002 | Saitama | 350-0495 | Japan |
| Investigational Site Number 3920001 | Tokyo | 113-8431 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on safety population which included all enrolled participants who took at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 IV infusion on Day 0, Day 7, Day 21 and thereafter every 2 weeks (maximum duration: 49 weeks) in the current study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Analysis was performed on safety population. | Posted | Count of Participants | Participants | From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks) |
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| Primary | 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. | Analysis was performed on safety population. | Posted | Count of Participants | Participants | From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks) |
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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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 IV infusion on Day 0, Day 7, Day 21 and thereafter every 2 weeks (maximum duration: 49 weeks) in the current study. | 1 | 7 | 1 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spontaneous Bacterial Peritonitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Cholangitis Acute | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
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| Chronic Kidney Disease | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Gingivitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Skin Candida | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Lip Haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Hepatic Cirrhosis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
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| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Epidermolysis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Vaccination Site Pain | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Blood Immunoglobulin M Increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Blood Iron Decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Blood Pressure Increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| C-Reactive Protein Increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Cytomegalovirus Test Positive | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Skin Laceration | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2022 | Aug 2, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000744 | Anemia, Hemolytic, Autoimmune |
| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000634098 | sutimlimab |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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