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

NCT ID: NCT07213583

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-28

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Amyloid Transthyretin Cardiomyopathy

Keywords

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Amyloid Depleter ALXN2220 Transthyretin Amyloid Cardiomyopathy Transthyretin amyloid (ATTR) Transthyretin (TTR) Amyloidosis ATTR-CM

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALXN2220

Participants will receive ALXN2220 via intravenous (IV) infusion during the Active Treatment Period

Group Type EXPERIMENTAL

ALXN2220

Intervention Type DRUG

Participants will receive ALXN2220 via IV infusion.

Interventions

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ALXN2220

Participants will receive ALXN2220 via IV infusion.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Neurimmune AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Henri Mondor

Créteil, , France

Site Status

CHU de Rennes - Hôpital Pontchaillou

Rennes, , France

Site Status

CHU Toulouse - Hôpital Rangueil

Toulouse, , France

Site Status

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, , Spain

Site Status

Countries

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France Germany Netherlands Spain

Other Identifiers

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2025-520506-35-00

Identifier Type: CTIS

Identifier Source: secondary_id

NI006-102

Identifier Type: -

Identifier Source: org_study_id