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ALXN2350 in Adult Participants With BAG3-Associated Dilated Cardiomyopathy

RecruitingPhase 1, Phase 2Ages 18 Years - 70 YearsAllAlexion Pharmaceuticals, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • ALXN2350
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Where

11 sites
Research Site
Birmingham, United States
Research Site
Palo Alto, United States
Research Site
Boston, United States
Research Site
Cincinnati, United States
Research Site
Portland, United States
Research Site
Philadelphia, United States
Research Site
Houston, United States
Research Site
Massa, Italy

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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