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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
U1111-1266-5421
Secondary ID [2] 0 0
LTS17352
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cold Agglutinin Disease 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Timepoint [1] 0 0
From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
Primary outcome [2] 0 0
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)
Timepoint [2] 0 0
From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)

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.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/11/2022
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Japan
State/province [1] 0 0
Ishikawa
Country [2] 0 0
Japan
State/province [2] 0 0
Kanagawa
Country [3] 0 0
Japan
State/province [3] 0 0
Osaka
Country [4] 0 0
Japan
State/province [4] 0 0
Saitama
Country [5] 0 0
Japan
State/province [5] 0 0
Tokyo

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05132127
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries