Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

Study Identifier:
D6810C00001
ClinicalTrials.gov Identifier:
NCT06183931
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Recruitment Complete

Study Details

Medical Condition
  • Transthyretin Amyloid Cardiomyopathy
Study Drug
  • Drug: ALXN2220
  • Drug: Placebo
Date
Jan 2024 - Jun 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 90 Years
Requirements Information
Inclusion and Exclusion 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
Sex
Female & Male
Age
18 - 90 Years

Study Details

Medical Condition
  • Transthyretin Amyloid Cardiomyopathy
Study Drug
  • Drug: ALXN2220
  • Drug: Placebo
Date
Jan 2024 - Jun 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 90 Years years
Requirements Information
Inclusion and Exclusion 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

Protocol Summary

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.

Trial Locations

Location
Status
Location
Research Site
Irvine, California, United States, 92614
Status
N/A
Location
Research Site
La Jolla, California, United States, 92037
Status
N/A
Location
Research Site
Palo Alto, California, United States, 94304
Status
N/A
Location
Research Site
San Francisco, California, United States, 94143
Status
N/A
Location
Research Site
Aurora, Colorado, United States, 80045
Status
N/A
Location
Research Site
Washington D.C., District of Columbia, United States, 20010
Status
N/A
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