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

Phase 3

Completed

• Conditions: Cold Agglutinin Disease
• Interventions: Drug: sutimlimab

• Registration Number: NCT05132127
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2021-11-11
• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-24
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Results First Submitted: 2023-08-02
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-08
• Last Update Submitted: 2023-09-08
• Results First Posted: 2023-10-03
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sutimlimab	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)	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)	From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)	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.

Trial Locations

Locations (5)

Investigational Site Number 3920003; 🇯🇵 Osaka, Japan

Investigational Site Number 3920002; 🇯🇵 Saitama, Japan

Investigational Site Number 3920001; 🇯🇵 Tokyo, Japan

Investigational Site Number 3920004; 🇯🇵 Kanagawa, Japan

Investigational Site Number 3920005; 🇯🇵 Ishikawa, Japan