Study of Re-Treatment With ALXN2220 in Patients With ATTR-CM

Neurimmune

Status and phase

Active, not recruiting

Phase 2

Conditions

Amyloid Transthyretin Cardiomyopathy

Treatments

Drug: ALXN2220

Study type

Interventional

Funder types

Industry

Identifiers

NCT07213583

NI006-102

2025-520506-35-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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