Status:
ACTIVE_NOT_RECRUITING
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Transthyretin Amyloid Cardiomyopathy
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief 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 as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2027
Estimated Enrollment :
1160 Patients enrolled
Trial Details
Trial ID
NCT06183931
Start Date
January 11 2024
End Date
October 5 2027
Last Update
December 17 2025
Active Locations (212)
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1
Research Site
Irvine, California, United States, 92614
2
Research Site
La Jolla, California, United States, 92037
3
Research Site
Palo Alto, California, United States, 94304
4
Research Site
San Francisco, California, United States, 94143