Sutimlimab (BIVV009) for the adult participants with cold agglutinin disease (CAD) who have completed Phase 3 studies (CARDINAL or CADENZA) in Japan

JRCT ID: jRCT2031210392

Registered date:27/10/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cold Agglutinin Disease
• Date of first enrollment: 07/12/2021
• Target sample size: 7
• Study type: Interventional

Intervention(s)

Drug: sutimlimab (BIVV009)
Pharmaceutical Form: solution for injection, Route of Administration: intravenous(iv)

Outcome(s)

Primary Outcome

1. Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Approximately 1 year ]

2. Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) [ Time Frame: Approximately 1 year ]

• Secondary Outcome: N/A

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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 cold agglutinin disease (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

Exclude criteria

Participants are excluded from the study if any of the following criteria apply:
- Clinical diagnosis of systemic lupus erythematosus (SLE) or immune complex mediated autoimmune disorders.
- Participants who meet recent Rituximab and/or immunosuppressive therapy.
- Any of the following medical conditions:
a) Active, serious intercurrent illness which will preclude enrolment until recovery is complete.
b) 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.

Related Information

• Primary Sponsor: Tanaka Tomoyuki
• Secondary ID(s): NCT05132127