DRUG
ALXN2220
Participants will receive ALXN2220 via IV infusion.
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Status
Active, not recruiting
Phase
Phase 3
Enrollment
1,181
Locations
212
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
Participants will receive placebo via IV infusion.
Timeline
From registration to results.
First posted
Dec 28, 2023
Study start
Jan 11, 2024
Primary completion
Jun 7, 2027
Study completion
Oct 5, 2027
Results posted
Not reported
Registry updated
Feb 23, 2026
Outcomes
What the study measures.
Primary outcomes
Total Occurrence of ACM and CV clinical events during the Blinded Treatment Period
Time frame · Baseline up to the end study (up to Month 48)
Secondary outcomes
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Overall Score (KCCQ-OS) at Month 24
Time frame · Baseline, Month 24
Time to CV-related Mortality
Time frame · Baseline up to the end of study (up to Month 48)
Change from Baseline in Six-minute Walk Test (6MWT) at Month 24
Time frame · Baseline, Month 24
Total Occurrences of CV Clinical Events
Time frame · Baseline up to the end of study (up to Month 48)
Time to ACM
Time frame · Baseline up to the end of study (up to Month 48)
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 90 Years
- Sex
- ALL
- 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
Study locations
212 registered sites.
Argentina · Australia · Austria · Belgium · Brazil · Canada · China · Czechia · Denmark · France · Germany · Greece · Ireland · Israel · Italy · Japan · Netherlands · Norway · Poland · South Korea · Spain · Sweden · Switzerland · Taiwan · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Irvine, California, United States
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
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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