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

Phase 2Active Not RecruitingNCT07213583

Neurimmune AG35 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amyloid Transthyretin Cardiomyopathy

Interventions

ALXN2220DRUG

Participants will receive ALXN2220 via IV infusion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Hôpital Henri Mondor

Créteil, France

CHU de Rennes - Hôpital Pontchaillou

Rennes, France

CHU Toulouse - Hôpital Rangueil

Toulouse, France

Universitätsklinikum Heidelberg

Heidelberg, Germany

Outcomes

Primary Outcomes

Change from Baseline to Week 48 in ECV measured by cMRI

Time frame: Baseline, Week 48

Change from Baseline to Week 48 in Heart Retention/Whole Body Retention measured by scintigraphy

Time frame: Baseline, Week 48

Secondary Outcomes

Incidence of TEAEs, including serious TEAEs

Time frame: From Baseline up to Week 48

ALXN2220 serum concentrations

Time frame: From Baseline up to Week 48

Incidence of Anti-Drug Antibodies

Time frame: From Baseline up to Week 48

Data from ClinicalTrials.gov

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