Status:
RECRUITING
ALXN2350 in Adult Participants With BAG3-Associated Dilated Cardiomyopathy
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
BAG3 Mutation Associated Dilated Cardiomyopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This Phase 1/2 study is an open-label, dose finding and dose expansion study investigating the safety, tolerability, and efficacy of a single IV infusion of ALXN2350 in adult participants with BAG3 as...
Eligibility Criteria
Inclusion
- Pathogenic or likely pathogenic mutation in BAG3
- Medical history of diagnosis of DCM
- Stable combination of HF SoC medications
- Adequate acoustic windows for echocardiography
Exclusion
- Presence of antibodies to AAV9
- Presence of a pathogenic or likely pathogenic variant in another gene where that other gene is authoritatively recognized as causal for DCM.
- Decompensated HF
- Note: Other inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
October 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 27 2032
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT07218887
Start Date
October 24 2025
End Date
January 27 2032
Last Update
December 12 2025
Active Locations (2)
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1
Research Site
Birmingham, Alabama, United States, 35233
2
Research Site
Portland, Oregon, United States, 97239-3098