MAGNITUDE: A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
Status: Active_not_recruiting
Location: See all (125) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• Documented diagnosis of ATTR amyloidosis with cardiomyopathy
• Medical history of heart failure (HF)
• Symptoms of HF are optimally managed and clinically stable within 28 days prior to administration of study intervention
• Screening NT-proBNP, a blood marker of HF severity, greater than or equal to 600 pg/mL and less than 10,000 pg/mL
Locations
United States
Arizona
University of Arizona
Tucson
California
Cedars-Sinai Medical Center
Los Angeles
Western Greater Los Angeles VA Medical Center
Los Angeles
Stanford University
Palo Alto
University of California, San Diego (UCSD) - Medical Center
San Diego
Colorado
University of Colorado Denver
Denver
Connecticut
Yale University School of Medicine
New Haven
Washington, D.c.
MedStar Washington Hospital Center - MedStar Heart and Vascular Institute
Washington D.c.
Florida
Mayo Clinic - Jacksonville
Jacksonville
Cleveland Clinic of Florida
Weston
Georgia
Emory University School of Medicine
Atlanta
Illinois
Northwestern University
Chicago
Indiana
Indiana University Health
Indianapolis
Kentucky
University of Kentucky Gill Heart Institute
Lexington
Massachusetts
Boston University School of Medicine
Boston
Brigham and Women's Hospital
Boston
Maryland
Johns Hopkins University
Baltimore
Michigan
University of Michigan
Ann Arbor
Minnesota
Mayo Clinic
Rochester
Missouri
St. Luke's Hospital
Kansas City
North Carolina
Duke University Medical Center
Durham
New York
Columbia University Medical Center
New York
New York University (NYU) School of Medicine - Langone Medical Center
New York
Ohio
Cleveland Clinic
Cleveland
Ohio Health Research Institute
Columbus
Oregon
Oregon Health and Science University (OHSU)
Portland
Pennsylvania
Penn Presbyterian Medical Center
Philadelphia
Allegheny General Hospital
Pittsburgh
University of Pittsburgh Medical Center
Pittsburgh
South Carolina
Medical University of South Carolina
Charleston
Texas
Baylor Scott & White Research Institute
Dallas
University of Texas Southwestern Medical Center
Dallas
Baylor College of Medicine
Houston
Houston Methodist Hospital
Houston
Baylor Scott and White - The Heart Hospital Baylor Plano
Plano
Virginia
INOVA Fairfax Hospital
Falls Church
Virginia Commonwealth University - Department of Internal Medicine
Richmond
Other Locations
Argentina
Fundacion Favalro
Buenos Aires
Hospital Italiano de Buenos Aires
Buenos Aires
ICBA
Buenos Aires
Fundacion Favaloro
Ciudad Autonoma De Buenos Aire
Hospital Italiano de Buenos Aires
Ciudad Autonoma De Buenos Aire
Hospital Privado de Rosario
Rosario
Australia
Royal Adelaide Hospital
Adelaide
Eastern Health - Box Hill Hospital
Box Hill
The Canberra Hospital
Garran
The Alfred Hospital
Melbourne
Fiona Stanley Hospital
Perth
Westmead Hospital
Westmead
Princess Alexandra Hospital
Woolloongabba
Austria
Medizinische Universitaet Innsbruck
Innsbruck
Universitaesklinikum St. Poelten
Sankt Pölten
Belgium
AZ Sint-Jan Brugge
Bruges
Universite Libre de Bruxelles (ULB) - Hopital Erasme
Brussels
Antwerp University Hospital
Edegem
UZ Leuven
Leuven
Centre Hospitalier Regional de la Citadelle
Liège
Brazil
Centro de Pesquisa NUPEC - Instituto Orizonti em Belo Horizonte
Belo Horizonte
Complexo Hospitalar de Niterói (CHN-DASA)
Niterói
CAPED - Centro Avancado de Pesquisa
Ribeirão Preto
HCFMRP - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ribeirão Preto
Cardiopulmonar da Bahia S. A. (Hospital Cardio Pulmonar)
Salvador
Hospital Israelita Albert Einstein
São Paulo
Instituto Dante Pazzanese de Cardiologia
São Paulo
Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP
São Paulo
PSEG Centro de Pesquisa Clinica S.A.
São Paulo
Canada
Alberta Health Services - University of Calgary
Calgary
McGill University Health Centre
Montreal
University Health Network - Toronto General Hospital
Toronto
Vancouver Coastal Health Research Institute
Vancouver
Denmark
Aarhus University Hospital
Aarhus
Rigshospitalet
Copenhagen
France
AP-HP Hopital Henri Mondor
Créteil
AP-HM - Hopital de la Timone
Marseille
AP-HP Hopital Bichat - Claude Bernard
Paris
CHU Rennes - Hopital Pontchaillou
Rennes
CHU de Toulouse - Hopital Rangueil
Toulouse
Germany
Charite Universitaetsmedizin Berlin
Berlin
Universitaetsklinikum Essen
Essen
Universitaetsklinikum Heidelberg
Heidelberg
Universitaetsklinikum Wuerzburg
Würzburg
Hungary
Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika
Budapest
Israel
Rambam Health Care Campus
Haifa
Hadassah University Hospital, Ein Karem
Jerusalem
Sheba Medical Center
Tel Litwinsky
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna
Cona
Azienda Ospedaliero-Universitaria Careggi
Florence
Ospedale Policlinico San Martino IRCCS
Genova
Fondazione IRCCS Policlinico San Matteo
Pavia
Fondazione Toscana Gabriele Monasterio per la Ricerca Medica
Pisa
Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
Trieste
Japan
Kumamoto University Hospital
Kumamoto
National Cerebral and Cardiovascular Center
Osaka
The University of Tokyo Hospital
Tokyo
Toyama University Hospital
Toyama
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City
Netherlands
University Medical Center
Groningen
Erasmus MC
Rotterdam
Universitair Medisch Centrum Utrecht
Utrecht
New Zealand
New Zealand Clinical Research
Auckland
New Zealand Clinical Research
Christchurch
Norway
Oslo University Hospital - Rikshospitalet
Oslo
Portugal
Centro Hospitalar Universitario de Lisboa Norte
Lisbon
Centro Hospitalar Universitario do Porto
Porto
Singapore
National Heart Centre
Singapore
National University Hospital
Singapore
Spain
Hospital Universitario de A Coruna
A Coruña
Hospital Universitari de Bellvitge
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Universitario Puerta de Hierro
Majadahonda
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Universitario Son Llatzer
Palma De Mallorca
Sweden
Karolinska University Hospital
Stockholm
University Hospital of Umea
Umeå
Taiwan
Far Eastern Memorial Hospital
New Taipei City
National Taiwan University Hospital
Taipei
Taipai Veterans General Hospital
Taipei
United Kingdom
Synexus Midlands Clinical Research Centre
Birmingham
Synexus Wales Clinical Research Centre
Cardiff
Synexus Scotland Clinical Research Centre
Glasgow
Synexus Hexham Clinical Research Centre
Hexham
Synexus Merseyside Clinical Research Centre
Liverpool
Richmond Pharmacology
London
Synexus Manchester Clinical Research Centre
Manchester
Time Frame
Start Date: 2023-12-13
Completion Date: 2028-04
Participants
Target number of participants: 1200
Treatments
Experimental: NTLA-2001
Single intravenous (IV) infusion of NTLA-2001
Placebo_comparator: Placebo
Single IV infusion of normal saline
Related Therapeutic Areas
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: Intellia Therapeutics