ALXN2350 in Adult Participants With BAG3-Associated Dilated Cardiomyopathy

Study Identifier:
D7030C00001
ClinicalTrials.gov Identifier:
NCT07218887
EudraCT Identifier:
N/A
EU CT ID:
2024-519674-40-00
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
1-855-752-2356 or [email protected]
Will Be Recruiting

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: ALXN2350
Date
Dec 2025 - Jul 2030
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 70 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion 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
  • 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
  • Note: Other inclusion and exclusion criteria may apply.
Sex
Female & Male
Age
18 - 70 Years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: ALXN2350
Date
Dec 2025 - Jul 2030
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 70 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion 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
  • 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
  • Note: Other inclusion and exclusion criteria may apply.

Protocol 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.

Trial Locations

No locations found.