Summary

Eligibility
for people ages 18-90 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The primary objective of this study is to assess 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 composite endpoint of all-cause mortality (ACM) and total 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)

Keywords

Transthyretin Amyloid Cardiomyopathy, Amyloid Depleter, ALXN2220, Transthyretin amyloid (ATTR), Transthyretin (TTR), N-terminal pro b-type natriuretic peptide (NT-proBNP), NT-proBNP, Amyloidosis, ATTR-CM, Cardiomyopathies

Eligibility

You can join if…

Open to people ages 18-90

  • Centrally confirmed diagnosis of ATTR-CM with either wild-type or variant TTR genotype
  • End-diastolic interventricular septal wall thickness ≥ 11 mm for women or ≥ 12 mm for men 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

You CAN'T join if...

  • 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

  • Research Site not yet accepting patients
    San Francisco California 94143 United States
  • Research Site not yet accepting patients
    Palo Alto California 94304 United States
  • Research Site accepting new patients
    Columbus Ohio 43210 United States
  • Research Site accepting new patients
    Kurume-shi 830-0011 Japan
  • Research Site accepting new patients
    Kyoto-shi 602-8566 Japan
  • Research Site not yet accepting patients
    Matsumoto-shi 390-8621 Japan
  • Research Site not yet accepting patients
    Sapporo-shi 060-8543 Japan
  • Research Site not yet accepting patients
    Shinjuku-ku 160-8582 Japan
  • Research Site not yet accepting patients
    Suita-shi 564-8565 Japan

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Alexion Pharmaceuticals, Inc.
ID
NCT06183931
Phase
Phase 3 Cardiomyopathy Research Study
Study Type
Interventional
Participants
Expecting 1000 study participants
Last Updated