Clinical trial NCT05132127: Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cold Agglutinin Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2021-11-24
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
measure: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Ishikawa
country: Japan
facility: Investigational Site Number 3920005
city: Kanagawa
country: Japan
facility: Investigational Site Number 3920004
city: Osaka
country: Japan
facility: Investigational Site Number 3920003
city: Saitama
country: Japan
facility: Investigational Site Number 3920002
city: Tokyo
country: Japan
facility: Investigational Site Number 3920001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: