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

Last updated: December 18, 2025
Sponsor: Neurimmune AG
Overall Status: Active - Not Recruiting

Phase

2

Condition

Amyloidosis

Treatment

ALXN2220

Clinical Study ID

NCT07213583
NI006-102
2025-520506-35-00
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must have received at least one dose of ALXN2220 in Study NI006-101

Exclusion

Exclusion Criteria:

  • Suspected or known intolerance/allergy to proteins or any components of the studydrug

  • Treatment or study discontinuation in Study NI006-101 due to a treatment-relatedadverse event that was serious, severe or life-threatening (on Common terminologycriteria for adverse events (CTCAE) scale)

  • Any new or uncontrolled condition after completion of Study NI006-101 that couldmake the participant unsuitable for participation in this study

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: ALXN2220
Phase: 2
Study Start date:
August 28, 2025
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

  • Hôpital Henri Mondor

    Créteil 3022530, 94000
    France

    Site Not Available

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes 2983990, 35033
    France

    Site Not Available

  • CHU Toulouse - Hôpital Rangueil

    Toulouse 2972315, 31059
    France

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg 2907911, 69120
    Germany

    Site Not Available

  • University Medical Center Groningen

    Groningen 2755251, 9713
    Netherlands

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda 3117667, 28222
    Spain

    Site Not Available

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