Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Transthyretin Amyloid Cardiomyopathy

In brief

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.

Key facts

Study ID

NCT06183931

Run by

Alexion Pharmaceuticals, Inc.

People needed

1181

Starts

2024-01-11

Expected to finish

2027-10-05

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — La Jolla, California, United States
• Research Site — Palo Alto, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Weston, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Stony Brook, New York, United States
• Research Site — Chapel Hill, North Carolina, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Portland, Oregon, United States
• Research Site — Danville, Pennsylvania, United States
• Research Site — Irvine, California, United States

Full record on ClinicalTrials.gov

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