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Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

Transthyretin Amyloid Cardiomyopathy

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 to 90

Participation 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

Study Location

Research Site
Research Site
Calgary, Alberta
Canada

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Research Site
Research Site
Toronto, Ontario
Canada

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Research Site
Research Site
Rimouski, Quebec
Canada

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Research Site
Research Site
London, Ontario
Canada

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Research Site
Research Site
Montréal, Quebec
Canada

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Research Site
Research Site
Vancouver, British Columbia
Canada

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Research Site
Research Site
Chicoutimi, Quebec
Canada

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Research Site
Research Site
Winnipeg, Manitoba
Canada

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Research Site
Research Site
Montréal, Quebec
Canada

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Study Sponsored By
Alexion Pharmaceuticals, Inc.
Participants Required
More Information
Study ID: NCT06183931