Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Trial ID or NCT#
NCT06183931
Status
NOT RECRUITING
Purpose
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.
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Amyloid Depleter ALXN2220 in Adult Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Eligibility Criteria
Ages Eligible for Study: 18 to 90
Sexes Eligible for Study: ALL
Accepts 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
Investigator(s)
Kevin M. Alexander, MD, FACC, FHFSA
Heart failure cardiologist
Assistant Professor of Medicine (Cardiovascular Medicine)
Ronald M Witteles
Cardiologist,
Heart failure cardiologist
Professor of Medicine (Cardiovascular Medicine)
Contact us to find out if this trial is right for you.
Contact
Alexion Pharmaceuticals, Inc. (Sponsor)
1-855-752-2356
View on ClinicalTrials.gov
