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

Phase 3

• Conditions: Cold Agglutinin Disease

• Registration Number: JPRN-jRCT2031210392
• Lead Sponsor: Tanaka Tomoyuki

Brief Summary

All 7 participants who completed the previous studies in Japan were enrolled and received sutimlimab. All 7 participants experienced at least 1 TEAE. The most frequently reported TEAEs were back pain and pyrexia. In total, 3 TESAEs (cholangitis acute, spontaneous bacterial peritonitis, and chronic kidney disease) were reported in 1 participant who died. All of TESAEs were assessed as not related to sutimlimab. There were no other participants who had serious TEAEs. No AESIs were reported in the study.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-27
• Study Completion: 2022-11-15
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

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

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 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

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified