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Active, not recruiting Phase 2

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

NCT07213583 · tracked via the Priya Life Science Spain tracker
Sponsor
Neurimmune AG
Phase
Phase 2
Started
2025-08-28
Last updated
2026-10-07

Condition(s) studied

Amyloid Transthyretin Cardiomyopathy

Investigational drug(s) / intervention(s)

ALXN2220 →

ALXN2220: Participants will receive ALXN2220 via IV infusion.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change from Baseline to Week 48 in ECV measured by cMRI — Baseline, Week 48
  • Change from Baseline to Week 48 in Heart Retention/Whole Body Retention measured by scintigraphy — Baseline, Week 48

Trial sites (6)

FacilityCityRegionStatus
Hôpital Henri Mondor Créteil France
CHU de Rennes - Hôpital Pontchaillou Rennes France
CHU Toulouse - Hôpital Rangueil Toulouse France
Universitätsklinikum Heidelberg Heidelberg Germany
University Medical Center Groningen Groningen Netherlands
Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07213583 on ClinicalTrials.gov ↗ ← All trials in Spain