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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2022-11-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cold Agglutinin Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

sutimlimab

Intervention Type DRUG

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

Interventions

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sutimlimab

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No