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Clinical Trials in the USA / NCT06183931
Active, not recruiting Phase 3

Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

NCT06183931 · tracked via the Priya Life Science USA tracker
Sponsor
Alexion Pharmaceuticals, Inc.
Phase
Phase 3
Started
2024-01-11
Last updated
2026-08-10

Condition(s) studied

Transthyretin Amyloid Cardiomyopathy

Investigational drug(s) / intervention(s)

ALXN2220Placebo

ALXN2220: Participants will receive ALXN2220 via IV infusion.

Placebo: Participants will receive placebo via IV infusion.

Study summary

The primary objective of this study is to access the efficacy of ALXN2220 in the treatment of adult participants with ATTR-CM by evaluating the difference between the ALXN2220 and placebo groups as assessed by the total occurrences of all-cause mortality (ACM) and cardiovascular (CV) clinical events.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of ATTR-CM with either wild-type or variant TTR genotype * End-diastolic interventricular septal wall thickness ≥ 12 mm on echocardiography measured at Screening * NT-proBNP \> 2000 pg/mL at Screening * Treatment with a loop diuretic for at least 30 days prior to Screening * History of heart failure NYHA Class II-IV at Screening * Life expectancy of ≥ 6 months as per the Investigator's judgment * Males and females of childbearing ability must use contraception Exclusion Criteria: * Known leptomeningeal amyloidosis * Known light chain (AL) or secondary amyloidosis (AA), or any other form of systemic amyloidosis * Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening * Uncontrolled clinically significant cardiac arrhythmia, per Investigator's assessment * LVEF \< 30% on echocardiography * Renal failure requiring dialysis or an eGFR \< 20 mL/min/1.73 m2 at Screening * Polyneuropathy with PND score IV

Primary outcome measure(s)

Trial sites (213)

FacilityCityRegionStatus
Research Site Irvine California
Research Site La Jolla California
Research Site Palo Alto California
Research Site San Francisco California
Research Site Aurora Colorado
Research Site Washington D.C. District of Columbia
Research Site Jacksonville Florida
Research Site Weston Florida
Research Site Atlanta Georgia
Research Site Atlanta Georgia
Research Site Chicago Illinois
Research Site Indianapolis Indiana
Research Site Boston Massachusetts
Research Site Boston Massachusetts
Research Site Kansas City Missouri
Research Site St Louis Missouri
Research Site New York New York
Research Site New York New York
Research Site Stony Brook New York
Research Site Chapel Hill North Carolina
Research Site Durham North Carolina
Research Site Cleveland Ohio
Research Site Columbus Ohio
Research Site Portland Oregon
Research Site Danville Pennsylvania
Research Site Philadelphia Pennsylvania
Research Site Charleston South Carolina
Research Site Greenville South Carolina
Research Site Memphis Tennessee
Research Site Fort Worth Texas
Research Site Houston Texas
Research Site Salt Lake City Utah
Research Site Falls Church Virginia
Research Site Richmond Virginia
Research Site Seattle Washington
Research Site Madison Wisconsin
Research Site Buenos Aires Argentina
Research Site CABA Argentina
Research Site Ciudad de Buenos Aires Argentina
Research Site Ciudad de Buenos Aires Argentina

+ 173 more sites — see the full list on the official registry below.

More Alexion Pharmaceuticals, Inc. trials in the USA

Other trials for the same condition

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 NCT06183931 on ClinicalTrials.gov ↗ ← All trials in the USA