CompletedPhase 3

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

Japan7 participantsStarted 2021-11-11

Plain-language 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.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓-Participant must be adults.

Exclusion criteria

✕-Clinical diagnosis of systemic lupus erythematosus or immune complex-mediated autoimmune disorders.
✕. Active, serious intercurrent illness which precluded enrolment until recovery was complete.
✕. Pregnancy or breast-feeding.

What they're measuring

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Timeframe: From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)

Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)

Timeframe: From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks)

Trial details

NCT IDNCT05132127

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-15

Results submitted2023-08-02

View on ClinicalTrials.gov More Cold Agglutinin Disease trials