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Monoclonal Antibodies

ALXN2220 for Transthyretin Amyloid Cardiomyopathy (DepleTTR-CM Trial)

Phase 3

Recruiting

Research Sponsored by Alexion Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treatment with a loop diuretic for at least 30 days prior to Screening

History of heart failure NYHA Class II-IV at Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to the end study (up to month 48)

Awards & highlights

DepleTTR-CM Trial Summary

This trial aims to test if a drug called ALXN2220 is effective in treating adults with a heart condition called ATTR-CM. The study will compare the results between the group taking ALX

Who is the study for?

This trial is for adults with ATTR-CM, a type of heart disease caused by amyloid buildup. Participants should have symptoms and evidence of the condition but not be on other treatments for it. Those with other types of cardiomyopathy or who can't follow the study protocol are excluded.Check my eligibility

What is being tested?

The study tests ALXN2220's effectiveness against a placebo in treating ATTR-CM. It measures which group has fewer deaths and cardiovascular events over time to see if ALXN2220 makes a difference.See study design

What are the potential side effects?

Possible side effects aren't specified here, but generally, new treatments like ALXN2220 could cause unexpected reactions ranging from mild discomfort to more serious conditions that would be closely monitored.

DepleTTR-CM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a water pill for at least 30 days.

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I have a history of moderate to severe heart failure.

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My heart condition is confirmed as ATTR-CM, either wild-type or variant.

DepleTTR-CM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to the end study (up to month 48)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to the end study (up to month 48)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to the end study (up to month 48) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite of Events of All-cause Mortality (ACM) and Total Cardiovascular (CV) Clinical Events

Secondary outcome measures

Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Overall Score (KCCQ-OS) at Month 24

Change from Baseline in Six-minute Walk Test (6MWT) at Month 24

Composite of Events of ACM and Total Heart Failure (HF)

+3 more

DepleTTR-CM Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ALXN2220Experimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor

253 Previous Clinical Trials

40,202 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"According to the information available on clinicaltrials.gov, this specific trial is no longer accepting candidates. Its initial posting was on January 4th, 2024 and the most recent update occurred on December 14th, 2023. However, it's worth noting that there are currently 262 other active clinical trials actively seeking participants at this time."

Answered by AI

In how many healthcare facilities is this clinical study currently being conducted?

"Currently, this clinical trial is actively recruiting patients from a total of 174 sites. These sites are located in various cities including Fort Worth, Washington, Darlinghurst, and an additional 174 locations. It would be advantageous to choose the site closest to your location to minimize travel obligations if you decide to participate."

Answered by AI

What is the level of safety associated with ALXN2220 when administered to patients?

"Based on the fact that this trial is in Phase 3 and there are multiple rounds of safety data available, our team at Power rates the safety of ALXN2220 as a 3."

Answered by AI

Is the inclusion criteria for this research study open to individuals aged 55 and above?

"To participate in this research study, patients must be between 18 and 90 years old. It is worth noting that there are also 21 trials available for individuals under the age of 18 and an additional 252 trials targeting participants over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

2024. "Study of ALXN2220 Versus Placebo in Adults With ATTR-CM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06183931.

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