Study of ALXN2220 Versus Placebo in Adults With ATTR-CM (DepleTTR-CM)

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ClinicalTrials.gov Identifier: NCT06183931

Recruitment Status : Recruiting

First Posted : December 28, 2023

Last Update Posted : April 24, 2024

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Alexion Pharmaceuticals, Inc.

Tracking Information

First Submitted Date ^ICMJE

November 15, 2023

First Posted Date ^ICMJE

December 28, 2023

Last Update Posted Date

April 24, 2024

Actual Study Start Date ^ICMJE

January 11, 2024

Estimated Primary Completion Date

August 29, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Composite of Events of All-cause Mortality (ACM) and Total Cardiovascular (CV) Clinical Events [ Time Frame: Baseline up to the end study (up to Month 48) ]

Original Primary Outcome Measures ^ICMJE

Composite of Events of All-cause Mortality (ACM) and Total Cardiovascular (CV) Clinical Events [ Time Frame: Month 24 to Month 48 ]

Change History

Current Secondary Outcome Measures ^ICMJE

Composite of Events of ACM and Total Heart Failure (HF) [ Time Frame: Baseline up to the end of study (up to Month 48) ]
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Overall Score (KCCQ-OS) at Month 24 [ Time Frame: Baseline, Month 24 ]
Time to CV-related Mortality [ Time Frame: Baseline up to the end of study (up to Month 48) ]
Change from Baseline in Six-minute Walk Test (6MWT) at Month 24 [ Time Frame: Baseline, Month 24 ]
Number of Participants With CV Clinical Events [ Time Frame: Baseline up to the end of study (up to Month 48) ]
Time to ACM [ Time Frame: Baseline up to the end of study (up to Month 48) ]

Original Secondary Outcome Measures ^ICMJE

Composite of Events of ACM and Total Heart Failure (HF) [ Time Frame: Month 24 to Month 48 ]
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Overall Score (KCCQ-OS) at Month 24 [ Time Frame: Baseline, Month 24 ]
Time to CV-related Mortality [ Time Frame: Month 24 to Month 48 ]
Change from Baseline in Six-minute Walk Test (6MWT) to 24 Months [ Time Frame: Baseline, Month 24 ]
Rate of CV Clinical Events [ Time Frame: Month 24 to Month 48 ]
Time to ACM [ Time Frame: Month 24 to Month 48 ]

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

Official Title ^ICMJE

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)

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Transthyretin Amyloid Cardiomyopathy

Intervention ^ICMJE

Drug: ALXN2220
Participants will receive ALXN2220 via IV infusion.
Drug: Placebo
Participants will receive placebo via IV infusion.

Study Arms ^ICMJE

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.

Intervention: Drug: ALXN2220
Placebo Comparator: Placebo
Participants will receive placebo via IV infusion q4w for at least 24 months up to a maximum of 48 months.

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1000

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

October 25, 2028

Estimated Primary Completion Date

August 29, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

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/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 90 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Alexion Pharmaceuticals, Inc. (Sponsor)

1-855-752-2356

clinicaltrials@alexion.com

Listed Location Countries ^ICMJE

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Norway, Poland, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT06183931

Other Study ID Numbers ^ICMJE

D6810C00001

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
Plan Description:	Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Supporting Materials:	Study Protocol
Supporting Materials:	Statistical Analysis Plan (SAP)
Supporting Materials:	Clinical Study Report (CSR)