Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

NCT06183931

Active Not RecruitingPhase 3

Sponsor: Alexion Pharmaceuticals, Inc.

Conditions: Transthyretin Amyloid Cardiomyopathy

Interventions: ALXN2220, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (213)
  • Irvine, California, United States
  • La Jolla, California, United States
  • Palo Alto, California, United States
  • San Francisco, California, United States
  • Aurora, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Jacksonville, Florida, United States
  • Weston, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Kansas City, Missouri, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • New York, New York, United States
  • Stony Brook, New York, United States
  • Chapel Hill, North Carolina, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • Danville, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Greenville, South Carolina, United States
  • Memphis, Tennessee, United States
  • Fort Worth, Texas, United States
  • + 183 more on CT.gov