Overview
This is a Phase 2, single-arm, multicenter study to evaluate the pharmacodynamics and safety of re-treatment with ALXN2220 in previous participants of Study NI006-101.
Description
This is a Phase 2, single arm, multicenter study to evaluate the pharmacodynamics and safety of re-treatment with ALXN2220 in the patient population of previous participants in Study NI006-101.
The study will also explore changes in cardiac structure and function, and clinical function of this dosing regimen, as well as changes in cardiac amyloid load, structure and function during the treatment-pause since conclusion of Study NI006-101. The study consists of a Screening Period and a 48 week Active Treatment Period.
Eligibility
Inclusion Criteria:
- Must have received at least one dose of ALXN2220 in Study NI006-101
Exclusion Criteria:
- Suspected or known intolerance/allergy to proteins or any components of the study drug
- Treatment or study discontinuation in Study NI006-101 due to a treatment-related adverse event that was serious, severe or life-threatening (on Common terminology criteria for adverse events (CTCAE) scale)
- Any new or uncontrolled condition after completion of Study NI006-101 that could make the participant unsuitable for participation in this study