NCT06073574

Brief Summary

The main purpose of this study is to measure the amyloid burden, defined as extracellular volume (ECV) assessed by Magnetic Resonance Imaging (MRI) over time in a subset of up to 150 participants enrolled in ION-682884-CS2 (NCT04136171).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
4 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2026

Completed
Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

5 years

First QC Date

October 4, 2023

Last Update Submit

September 9, 2026

Conditions

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Keywords

TTRAmyloidosisCardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • Change in the Percent of ECV in Participants Receiving ION-682884 vs. Placebo According to ION-682884-CS2 Treatment Groups

    From Baseline up to Week 140

Study Arms (1)

Experimental: ION-682884-CS2 MRI Scan Sub-set

Participants enrolled in the parent study ION-682884-CS2 (NCT04136171) to receive either eplontersen or placebo and who consented to participate in this sub-study will undergo cardiac MRI at Baseline, Weeks 25, 49, 97 and 140.

Diagnostic Test: Cardiac MRI

Interventions

Cardiac MRIDIAGNOSTIC_TEST

MRI Scans as specified in the corresponding arm group.

Experimental: ION-682884-CS2 MRI Scan Sub-set

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants who were randomized in Study ION-682884-CS2 (NCT04136171) and who signed informed consent for the MRI sub-study will participate in this sub-study.

You may not qualify if:

  • Contraindication or sensitivity to MRI contrast agents
  • Orthopnea of sufficient severity to preclude supine scanning at screening.
  • Weight or body girth exceeds the limits of the cardiac MRI machine specifications.
  • Contraindication to cardiac MRI scanning, as assessed by local MRI safety questionnaire/checklist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Azienda Ospedaliero - Universitaria Careggi

Florence, 50139, Italy

Location

Azienda Ospedale Università di Padova

Padova, 35128, Italy

Location

Hospital Universitario Puerta de Hierro

Majadahonda, 28222, Spain

Location

Synexus - Scotland Clinical Research Centre

Bellshill, ML4 3NJ, United Kingdom

Location

Synexus Midlands Clinical Research Centre

Birmingham, B15 2SQ, United Kingdom

Location

Synexus - Wales

Cardiff, CF15 9SS, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Richmond Pharmacology

London, SE1 1YR, United Kingdom

Location

Synexus - Manchester Clinical Research Centre

Manchester, M15 6SE, United Kingdom

Location

Related Links

MeSH Terms

Conditions

AmyloidosisCardiomyopathies

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 10, 2023

Study Start

March 31, 2021

Primary Completion

March 13, 2026

Study Completion

March 13, 2026

Last Updated

September 14, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.

More information

Locations

GB(6)US(2)IT(2)ES(1)