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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
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Transthyretin Amyloid Cardiomyopathy Drug: ALXN2220 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 11, 2024
Estimated Primary Completion Date : August 29, 2025
Estimated Study Completion Date : October 25, 2028

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


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06183931


Contacts
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Contact: Alexion Pharmaceuticals, Inc. (Sponsor) 1-855-752-2356 clinicaltrials@alexion.com

Locations
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Sponsors and Collaborators
Alexion Pharmaceuticals, Inc.
More Information
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Responsible Party: Alexion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT06183931    
Other Study ID Numbers: D6810C00001
First Posted: December 28, 2023    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexion Pharmaceuticals, Inc.:
Amyloid Depleter
ALXN2220
Transthyretin Amyloid Cardiomyopathy
Transthyretin amyloid (ATTR)
Transthyretin (TTR)
 N-terminal pro b-type natriuretic peptide (NT-proBNP)
NT-proBNP
Amyloidosis
ATTR-CM
Additional relevant MeSH terms:
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Cardiomyopathies
Amyloidosis
Heart Diseases
 Cardiovascular Diseases
Proteostasis Deficiencies
Metabolic Diseases