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Not recruiting

Phase 3

ALXN2220Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

Sponsor:

Alexion Pharmaceuticals, Inc.

Code:

NCT06183931

Conditions

Transthyretin Amyloid Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ALXN2220

Placebo

Study Details

Brief 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.

Conditions

Transthyretin Amyloid Cardiomyopathy

Study ID

NCT06183931

Start date

Jan 11, 2024

Status verified date

Feb, 2025

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALXN2220

Participants will receive weight-based dose of ALXN2220 via intravenous (IV) infusion every 4 weeks (q4w) for at least 24 months up to a maximum of 48 months.

placebo comparator: Placebo

Participants will receive placebo via IV infusion q4w for at least 24 months up to a maximum of 48 months.

Interventions

ALXN2220

Participants will receive ALXN2220 via IV infusion.

Placebo

Participants will receive placebo via IV infusion.

Primary outcome measure

Total Occurrence of ACM and CV clinical events during the Blinded Treatment Period [ Time Frame: Baseline up to the end study (up to Month 48) ]

Central Contacts and Locations

Central contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

1-855-752-2356 clinicaltrials@alexion.com

Locations

Research Site

Recruiting

Irvine, California, United States, 92614

Research Site

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La Jolla, California, United States, 92037

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Palo Alto, California, United States, 94304

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San Francisco, California, United States, 94143

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Aurora, Colorado, United States, 80045

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Washington, District of Columbia, United States, 20010

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Jacksonville, Florida, United States, 32224

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Weston, Florida, United States, 33331

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Atlanta, Georgia, United States, 30309

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Atlanta, Georgia, United States, 30322

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Indianapolis, Indiana, United States, 46202

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Kansas City, Kansas, United States, 66160

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Boston, Massachusetts, United States, 02115

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Boston, Massachusetts, United States, 02118

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Kansas City, Missouri, United States, 64111

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Saint Louis, Missouri, United States, 63110

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New York, New York, United States, 10016

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New York, New York, United States, 10032

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Stony Brook, New York, United States, 11794

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Chapel Hill, North Carolina, United States, 27599

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Durham, North Carolina, United States, 27705

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Cleveland, Ohio, United States, 44195

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Columbus, Ohio, United States, 43210

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Portland, Oregon, United States, 97239

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Danville, Pennsylvania, United States, 17822

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Philadelphia, Pennsylvania, United States, 19104

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Charleston, South Carolina, United States, 29425

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Greenville, South Carolina, United States, 29605

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Memphis, Tennessee, United States, 38120

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Nashville, Tennessee, United States, 37232

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Fort Worth, Texas, United States, 76104

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Houston, Texas, United States, 77030

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Salt Lake City, Utah, United States, 84132

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Falls Church, Virginia, United States, 22042

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Richmond, Virginia, United States, 23298

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Seattle, Washington, United States, 98195

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Madison, Wisconsin, United States, 53705

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Calgary, Alberta, Canada, T2N 1N4

Research Site

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Winnipeg, Manitoba, Canada, R2H 2A6

Research Site

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London, Ontario, Canada, N6C 2R5

Research Site

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Chicoutimi, Quebec, Canada, G7H 5H6

Research Site

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Montréal, Quebec, Canada, H1T 1C8

Research Site

Recruiting

Montréal, Quebec, Canada, H2X 1R9

Research Site

Recruiting

Rimouski, Quebec, Canada, G5L 5T1

More Information

Sponsor

Alexion Pharmaceuticals, Inc.

Last update posted

Feb 28, 2025

Last verified

Feb, 2025

Keywords

Amyloid Depleter
ALXN2220
All-cause mortality (ACM)
Cardiovascular (CV)
Transthyretin Amyloid Cardiomyopathy
Transthyretin amyloid (ATTR)
Transthyretin (TTR)
N-terminal pro b-type natriuretic peptide (NT-proBNP)
NT-proBNP
Amyloidosis
ATTR-CM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-22. This information was provided to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc. on 2025-02-28.