Evaluating ALXN2220 for treating heart disease caused by amyloidosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy of ALXN2220 compared to a placebo in adults diagnosed with Transthyretin Amyloid Cardiomyopathy (ATTR-CM). Participants will be monitored for occurrences of all-cause mortality and cardiovascular clinical events. The study includes adults with specific echocardiographic and biomarker criteria, ensuring a targeted approach to treatment. The trial is designed to provide insights into the potential benefits of ALXN2220 in managing this serious condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of ATTR-CM with either wild-type or variant TTR genotype
* End-diastolic interventricular septal wall thickness ≥ 12 mm 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

Where it's running

• Research Site
  Irvine, California, United States Recruiting
• Research Site
  La Jolla, California, United States Recruiting
• Research Site
  Palo Alto, California, United States Recruiting
• Research Site
  San Francisco, California, United States Recruiting
• Research Site
  Aurora, Colorado, United States Recruiting
• Research Site
  Washington, District of Columbia, United States Recruiting

+200 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
• Email: clinicaltrials@alexion.com
• Phone: 1-855-752-2356

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ocular Imaging to help detect ATTR-CM in adults with heart failure

  This multicenter pilot study tests whether eye imaging can help distinguish people with transthyretin amyloid cardiomyopathy from other heart failure patients.

  Recruiting AstraZeneca · Palo Alto, California and 19 other locations · NCT07690436

• Coramitug PET/CT imaging to track and affect heart amyloid in ATTR-CM

  This study tests whether a radioactive version of the antibody coramitug can be detected in and displaced from heart amyloid in people aged 60 and older with transthyretin amyloid cardiomyopathy, and whether the drug is safe and well tolerated.

  Recruiting Phase 1 Novo Nordisk A/S · Groningen · NCT07448623

• Switching from tafamidis to acoramidis to see how transthyretin blood levels change

  This test will see if switching people with transthyretin amyloid cardiomyopathy who are taking tafamidis to acoramidis raises transthyretin levels in the blood.

  Recruiting at 10 sites Phase 4 Bayer · Sankt Pölten, Lower Austria and 25 other locations · NCT07298044

• Characterizing wild-type transthyretin amyloidosis cardiomyopathy and its impact on quality of life

  This study is trying to understand how wild-type transthyretin amyloidosis cardiomyopathy affects the quality of life for patients at different stages of the disease compared to healthy individuals.

  Recruiting Aarhus University Hospital Skejby · Aarhus, Arrhus N · NCT06291805

• Acoramidis in adults with transthyretin amyloid cardiomyopathy in France

  This is an observational study to see how acoramidis is used in everyday care for adults with ATTR‑CM in France and how it affects their quality of life and daily function.

  Recruiting Bayer · Many Locations · NCT07791160

• Acoramidis for transthyretin amyloid cardiomyopathy in routine care

  See how acoramidis works for adults with transthyretin amyloid cardiomyopathy (wild-type or variant) when given as part of regular clinical care.

  Recruiting at 17 sites Bayer · Multiple Locations and 16 other locations · NCT07235462

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.