Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Launched by ALEXION PHARMACEUTICALS, INC. · Dec 14, 2023
Trial Information
Current as of May 14, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called ALXN2220 for adults with a heart condition called Transthyretin Amyloid Cardiomyopathy (ATTR-CM). The goal is to see how well ALXN2220 works compared to a placebo, which is a substance that has no active treatment. Researchers will look at the number of serious heart-related events in both groups to determine if ALXN2220 is effective.
To participate, individuals must have a confirmed diagnosis of ATTR-CM and meet certain health criteria, such as having a specific thickness in the heart wall and elevated levels of a certain protein in the blood. Eligible participants should be experiencing heart failure symptoms and have a life expectancy of at least six months. Those who join the trial will receive either the study drug or a placebo and will be closely monitored by healthcare professionals throughout the study. If you or someone you know is interested in this trial, it’s important to discuss it with a healthcare provider to understand more about the requirements and what to expect.
Gender
ALL
Eligibility criteria
- 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
About Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc. is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for patients with rare and complex diseases. With a strong focus on addressing unmet medical needs, Alexion leverages advanced science and technology to create transformative treatments that improve the quality of life for patients suffering from conditions such as complement-mediated disorders, neurology, hematology, and metabolic diseases. Committed to patient-centric approaches, Alexion collaborates with healthcare professionals, patients, and advocacy groups to drive clinical research and foster advancements in rare disease treatment.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Rochester, Minnesota, United States
Houston, Texas, United States
Cleveland, Ohio, United States
Chapel Hill, North Carolina, United States
Nashville, Tennessee, United States
Indianapolis, Indiana, United States
Miami, Florida, United States
Augusta, Georgia, United States
Memphis, Tennessee, United States
Brussels, , Belgium
Malaga, , Spain
Salamanca, , Spain
Aurora, Colorado, United States
New York, New York, United States
Columbus, Ohio, United States
Paris Cedex 13, , France
Berlin, , Germany
Kiel, , Germany
San Francisco, California, United States
Portland, Oregon, United States
Jerusalem, , Israel
Napoli, , Italy
Padova, , Italy
Lund, , Sweden
Zurich, , Switzerland
Brno, , Czechia
Praha 4, , Czechia
Philadelphia, Pennsylvania, United States
Bron, , France
Montpellier, , France
Atlanta, Georgia, United States
Graz, , Austria
Innsbruck, , Austria
Wels, , Austria
Wien, , Austria
Rennes, , France
Toulouse, , France
Hannover, , Germany
München, , Germany
Rotterdam, , Netherlands
Warszawa, , Poland
Basel, , Switzerland
Salt Lake City, Utah, United States
Haifa, , Israel
Rehovot, , Israel
Kansas City, Kansas, United States
La Jolla, California, United States
Washington, District Of Columbia, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
Durham, North Carolina, United States
Philadelphia, Pennsylvania, United States
Seattle, Washington, United States
Genk, , Belgium
Rio De Janeiro, , Brazil
Toronto, Ontario, Canada
Heidelberg, , Germany
Homburg, , Germany
Beer Yaakov, , Israel
Pavia, , Italy
Groningen, , Netherlands
Gdansk, , Poland
Krakow, , Poland
Richmond, Virginia, United States
Greenville, South Carolina, United States
Auckland, , New Zealand
Charleston, South Carolina, United States
Utrecht, , Netherlands
Köln, , Germany
Münster, , Germany
Milano, , Italy
Maastricht, , Netherlands
Göttingen, , Germany
Valencia, , Spain
Essen, , Germany
Stony Brook, New York, United States
Barcelona, , Spain
Pessac, , France
Jacksonville, Florida, United States
Box Hill, , Australia
Leipzig, , Germany
Roma, , Italy
Vancouver, British Columbia, Canada
Weston, Florida, United States
Providence, Rhode Island, United States
Fort Worth, Texas, United States
Beijing, , China
Shanghai, , China
München, , Germany
Rennes Cedex 9, , France
Bologna, , Italy
Dublin, , Ireland
Athens, , Greece
Torino, , Italy
Sao Paulo, , Brazil
Nantes Cedex 1, , France
Bern, , Switzerland
Majadahonda, , Spain
Cona, , Italy
Shinjuku Ku, , Japan
Danville, Pennsylvania, United States
Kyoto Shi, , Japan
Taipei, , Taiwan
Luzern, , Switzerland
Guangzhou, , China
Nanjing, , China
Gießen, , Germany
Busan, , Korea, Republic Of
Palma De Mallorca, , Spain
Göteborg, , Sweden
London, , United Kingdom
Poitiers, , France
Creteil, , France
Bonn, , Germany
Izmir, , Turkey
Chongqing, , China
Florence, , Italy
El Palmar, , Spain
Chicoutimi, Quebec, Canada
Marseille, , France
L'hospitalet De Llobregat, , Spain
Pamplona, , Spain
Palo Alto, California, United States
Dalian, , China
Hangzhou, , China
Wuhan, , China
Xi'an, , China
Pisa, , Italy
Madison, Wisconsin, United States
Buenos Aires, , Argentina
Glasgow, , United Kingdom
Kumamoto Shi, , Japan
Seoul, , Korea, Republic Of
Birmingham, , United Kingdom
Odense C, , Denmark
Irvine, California, United States
Ciudad Autonoma Buenos Aires, , Argentina
Darlinghurst, , Australia
Joondalup, , Australia
Melbourne, , Australia
Montréal, Quebec, Canada
Falls Church, Virginia, United States
Winnipeg, Manitoba, Canada
Göteborg, , Sweden
Ferrara, , Italy
Chambray Les Tours, , France
Hexham, , United Kingdom
Jinan, , China
Ankara, , Turkey
Homburg, , Germany
Bruges, , Belgium
Petah Tikva, , Israel
Kurume Shi, , Japan
Wonju Si, , Korea, Republic Of
Oslo, , Norway
New Taipei City, , Taiwan
Jaen, , Spain
Paris, , France
Bedford Park, , Australia
Westmead, , Australia
Bunkyo Ku, , Japan
Changsha, , China
Taichung, , Taiwan
Messina, , Italy
Aarhus, , Denmark
Suzhou, , China
Praha, , Czechia
Hefei, , China
Matsumoto Shi, , Japan
Copenhagen, , Denmark
Rimouski, Quebec, Canada
Porto Alegre, , Brazil
Guiyang, , China
Utrecht, , Netherlands
Mersin, , Turkey
Tianjin, , China
Stockholm, , Sweden
Madrid, , Spain
Trondheim, , Norway
Würzburg, , Germany
Lørenskog, , Norway
Suita Shi, , Japan
La Coruna, , Spain
Eskisehir, , Turkey
Chengdu, , China
Hamburg, , Germany
Campinas, , Brazil
Fuzhou, , China
Sapporo Shi, , Japan
Santiago De Compostela Coruña, , Spain
Calgary, Alberta, Canada
Poznań, , Poland
Lund, , Sweden
Fortaleza, , Brazil
São Paulo, , Brazil
Aracaju, , Brazil
London, , United Kingdom
Pilar, , Argentina
Ribeirão Preto, , Brazil
Brisbane, , Australia
Harbin, , China
Buenos Aires, , Argentina
Cordoba, , Argentina
Greifwald, , Germany
Caba, , Argentina
Dinar, , Turkey
Cologne, , Germany
Caba, , Argentina
London, Ontario, Canada
Minneapolis, Minnesota, United States
Créteil Cédex, , France
Forli, , Italy
Trieste, , Italy
Maastricht, , Netherlands
St.Gallen, , Switzerland
Zürich, , Switzerland
Istanbul, , Turkey
Cardiff, , United Kingdom
Saint Herblain, , France
Tianjin, , China
Manchester, , United Kingdom
Torrette, , Italy
Guiyang, , China
Skellefteå, , Sweden
Shanghai, , China
Caba, , Argentina
Ballinasloe, , Ireland
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported