Back to resultsSutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
Primary Purpose
Cold Agglutinin Disease
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
sutimlimab
Sponsored by
About this trial
This is an interventional treatment trial for Cold Agglutinin Disease
Eligibility Criteria
Inclusion Criteria:
--Participant must be adults.
- Participants who have been enrolled in, and has completed Part B of CARDINAL or CADENZA study
- Participants who have ongoing diagnosis of CAD
- Participants who continue 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 have acceptable benefit/risk profile
- Participant who has acceptable infection risk
- Participants who have no available appropriate alternative therapy for CAD
- Body weight of ≥39 kg
- Giving signed informed consent - - - -
Exclusion Criteria:
--Clinical diagnosis of systemic SLE or immune complex mediated autoimmune disorders
- Participants who meet recent Rituximab and/or immunosuppressive therapy
Any of the following medical conditions:
- Active, serious intercurrent illness which will preclude enrolment until recovery is complete.
- 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, contraindicates participation in the study
Sites / Locations
- Investigational Site Number 3920005
- Investigational Site Number 3920004
- Investigational Site Number 3920003
- Investigational Site Number 3920002
- Investigational Site Number 3920001
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sutimlimab
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05132127
Brief Title
Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cold Agglutinin Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sutimlimab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
sutimlimab
Intervention Description
Pharmaceutical form: solution for injection Route of administration: intravenous (IV)
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Description
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)
Title
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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:
Active, serious intercurrent illness which precluded enrolment until recovery was complete.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 3920005
City
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Facility Name
Investigational Site Number 3920004
City
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Investigational Site Number 3920003
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Investigational Site Number 3920002
City
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Investigational Site Number 3920001
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Learn more about this trial
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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