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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05132127
Registration number
NCT05132127
Ethics application status
Date submitted
11/11/2021
Date registered
24/11/2021
Date last updated
3/10/2023
Titles & IDs
Public title
Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
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Scientific 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
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Secondary ID [1]
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U1111-1266-5421
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Secondary ID [2]
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LTS17352
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cold Agglutinin Disease
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - sutimlimab
Experimental: Sutimlimab - 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.
Treatment: Drugs: sutimlimab
Pharmaceutical form: solution for injection Route of administration: intravenous (IV)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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Assessment method [1]
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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).
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Timepoint [1]
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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)
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Primary outcome [2]
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Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)
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Assessment method [2]
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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.
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Timepoint [2]
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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)
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Eligibility
Key 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.
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Minimum age
20
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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:
1. Active, serious intercurrent illness which precluded enrolment until recovery was complete.
2. 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/11/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/11/2022
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Sample size
Target
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Accrual to date
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Final
7
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Japan
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State/province [1]
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Ishikawa
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Country [2]
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Japan
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State/province [2]
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Kanagawa
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Country [3]
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Japan
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State/province [3]
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Osaka
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Country [4]
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Japan
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State/province [4]
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Saitama
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT05132127
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Clinical Sciences & Operations
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Address
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Sanofi
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05132127
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