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

Sponsor

Sanofi (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05132127

Collaborator

(none)

Enrollment

Locations

Arm

8.5

Anticipated Duration (Months)

1.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center, single treatment-group, open-label study to provide sutimlimab to the adult participants with cold agglutinin disease (CAD) who have completed the CARDINAL or CADENZA 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.

Condition or Disease	Intervention/Treatment	Phase
Cold Agglutinin Disease	Drug: sutimlimab	Phase 3

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 is determined by sutimlimab or other appropriate CAD therapy becoming commercially available to participants in Japan.

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 11, 2021

Anticipated Primary Completion Date :

Jul 29, 2022

Anticipated Study Completion Date :

Jul 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sutimlimab Participants in Japan with CAD who have completed CARDINAL or CADENZA studies will receive sutimlimab (BIVV009). The dosing schedule consists of an initial dose (Day 0), followed by a dose one week later (Day 7), which is followed by a maintenance dose every other week beginning on Day 21.	Drug: sutimlimab Pharmaceutical form: solution for injection Route of administration: intravenous(iv)

Arm

Intervention/Treatment

Experimental: sutimlimab

Participants in Japan with CAD who have completed CARDINAL or CADENZA studies will receive sutimlimab (BIVV009). The dosing schedule consists of an initial dose (Day 0), followed by a dose one week later (Day 7), which is followed by a maintenance dose every other week beginning on Day 21.

Drug: sutimlimab

Pharmaceutical form: solution for injection Route of administration: intravenous(iv)

Outcome Measures

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) [Approximately 1 year]
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) [Approximately 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Investigational Site Number 3920005	Ishikawa	Japan	920-8530
2	Investigational Site Number 3920004	Kanagawa	Japan	259-1193
3	Investigational Site Number 3920003	Osaka	Japan	565-0871
4	Investigational Site Number 3920002	Saitama	Japan	350-0495
5	Investigational Site Number 3920001	Tokyo	Japan	113-8431

Sponsors and Collaborators

Sanofi

Investigators

Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT05132127

Other Study ID Numbers:

LTS17352
U1111-1266-5421

First Posted:

Nov 24, 2021

Last Update Posted:

May 23, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Anemia, Hemolytic, Autoimmune

Study Results

No Results Posted as of May 23, 2022