Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

Description

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.

Conditions

Transthyretin Amyloid Cardiomyopathy

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Study Overview

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Study Details

Study overview

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.

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)

Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

Condition
Transthyretin Amyloid Cardiomyopathy
Intervention / Treatment

-

Contacts and Locations

Irvine

Research Site, Irvine, California, United States, 92614

La Jolla

Research Site, La Jolla, California, United States, 92037

Palo Alto

Research Site, Palo Alto, California, United States, 94304

San Francisco

Research Site, San Francisco, California, United States, 94143

Aurora

Research Site, Aurora, Colorado, United States, 80045

Washington

Research Site, Washington, District of Columbia, United States, 20010

Jacksonville

Research Site, Jacksonville, Florida, United States, 32224

Miami

Research Site, Miami, Florida, United States, 33176

Weston

Research Site, Weston, Florida, United States, 33331

Atlanta

Research Site, Atlanta, Georgia, United States, 30309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alexion Pharmaceuticals, Inc.,

Study Record Dates

2028-10-31