Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Trial ID or NCT#
NCT06183931
Status
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 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
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)
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
