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Recruiting NCT07218887

ALXN2350 in Adult Participants With BAG3-Associated Dilated Cardiomyopathy

Conditions: BAG3 Mutation Associated Dilated Cardiomyopathy

Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 6
Sponsor: Alexion Pharmaceuticals, Inc.

Location: Research Site Birmingham Alabama

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 associated DCM.

Eligibility Criteria

Inclusion Criteria: * Pathogenic or likely pathogenic mutation in BAG3 * Medical history of diagnosis of DCM * Stable combination of HF SoC medications * Adequate acoustic windows for echocardiography * LVEF \> 15% and ≤ 45% at Screening by echocardiography * Diagnosis of chronic HF for at least 3 months * NYHA Class I/II/III at Screening Exclusion Criteria: * 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 * Cardiac ventricular arrhythmia that requires treatment * History of untreated clinically significant valve disease or a Screening confirmation of severe aortic stenosis, severe mitral stenosis, moderate or severe aortic insufficiency or severe mitral insufficiency * NYHA Class IV * History of substance abuse that could contribute to cardiac dysfunction Note: Other inclusion and exclusion criteria may apply.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07218887). StuddyBuddy aggregates publicly available trial information.