Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan

Cold Agglutinin Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05132127
• Other study ID #: LTS17352
• Secondary ID: U1111-1266-5421
• Status: Completed
• Phase: Phase 3
• Start date: November 11, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: September 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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:

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.

Related Conditions & MeSH terms

• Anemia, Hemolytic, Autoimmune
• Cold Agglutinin Disease

Intervention

Drug:
• sutimlimab
Pharmaceutical form: solution for injection Route of administration: intravenous (IV)

Locations

Country	Name	City	State
Japan	Investigational Site Number 3920005	Ishikawa
Japan	Investigational Site Number 3920004	Kanagawa
Japan	Investigational Site Number 3920003	Osaka
Japan	Investigational Site Number 3920002	Saitama
Japan	Investigational Site Number 3920001	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)
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.	From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)