1000 Participants Needed

ALXN2220 for ATTR-CM

(DepleTTR-CM Trial)

Recruiting at 201 trial locations
AP
AP
Overseen ByAlexion Pharmaceuticals, Inc. (Sponsor)
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Alexion Pharmaceuticals, Inc.
Must be taking: Loop diuretics
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, since participants must have been on a loop diuretic for at least 30 days before screening, it seems that continuing certain medications might be required.

What is the purpose of this trial?

This trial is testing a new drug called ALXN2220 to help adults with a heart condition known as ATTR-CM. The goal is to see if the drug can lower the risk of death and serious heart issues. Researchers are comparing the outcomes between those who receive the drug and those who do not.

Eligibility Criteria

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.

Inclusion Criteria

NT-proBNP > 2000 pg/mL at Screening
I have been on a water pill for at least 30 days.
Life expectancy of ≥ 6 months as per the Investigator's judgment
See 4 more

Exclusion Criteria

I have been diagnosed with leptomeningeal amyloidosis.
I haven't had any major heart issues or surgeries in the last 3 months.
My heart rhythm is stable and not causing health issues.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ALXN2220 or placebo via IV infusion every 4 weeks for at least 24 months up to a maximum of 48 months

24-48 months
IV infusion every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • ALXN2220
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alexion Pharmaceuticals, Inc.

Lead Sponsor

Trials
267
Recruited
141,000+
Dr. Alberto R. Martinez profile image

Dr. Alberto R. Martinez

Alexion Pharmaceuticals, Inc.

Chief Medical Officer since 2010

MD from University of Sao Paulo

Marc Dunoyer profile image

Marc Dunoyer

Alexion Pharmaceuticals, Inc.

Chief Executive Officer since 2021

PhD in Molecular Biology

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