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: Recruiting
Location: See all (131) 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
RECRUITING
Tucson
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Western Greater Los Angeles VA Medical Center
RECRUITING
Los Angeles
Stanford University
RECRUITING
Palo Alto
University of California, San Diego (UCSD) - Medical Center
RECRUITING
San Diego
Colorado
University of Colorado Denver
RECRUITING
Denver
Connecticut
Yale University School of Medicine
RECRUITING
New Haven
Washington, D.c.
MedStar Washington Hospital Center - MedStar Heart and Vascular Institute
RECRUITING
Washington D.c.
Florida
Mayo Clinic - Jacksonville
RECRUITING
Jacksonville
Cleveland Clinic of Florida
RECRUITING
Weston
Georgia
Emory University School of Medicine
RECRUITING
Atlanta
Illinois
Northwestern University
RECRUITING
Chicago
Indiana
Indiana University Health
RECRUITING
Indianapolis
Kentucky
University of Kentucky Gill Heart Institute
RECRUITING
Lexington
Massachusetts
Boston University School of Medicine
RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
Barbara Ann Karmanos Cancer Institute
ACTIVE_NOT_RECRUITING
Detroit
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
St. Luke's Hospital
RECRUITING
Kansas City
North Carolina
Duke University Medical Center
RECRUITING
Durham
New York
Columbia University Medical Center
RECRUITING
New York
New York University (NYU) School of Medicine - Langone Medical Center
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Ohio Health Research Institute
RECRUITING
Columbus
Oregon
Oregon Health and Science University (OHSU)
RECRUITING
Portland
Pennsylvania
Penn Presbyterian Medical Center
RECRUITING
Philadelphia
Allegheny General Hospital
RECRUITING
Pittsburgh
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
Baylor Scott & White Research Institute
RECRUITING
Dallas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Baylor College of Medicine
RECRUITING
Houston
Houston Methodist Hospital
RECRUITING
Houston
Baylor Scott and White - The Heart Hospital Baylor Plano
RECRUITING
Plano
Virginia
INOVA Fairfax Hospital
RECRUITING
Falls Church
Virginia Commonwealth University - Department of Internal Medicine
RECRUITING
Richmond
Other Locations
Argentina
Fundacion Favalro
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
ICBA
RECRUITING
Buenos Aires
Fundacion Favaloro
RECRUITING
Ciudad Autonoma De Buenos Aire
Hospital Italiano de Buenos Aires
RECRUITING
Ciudad Autonoma De Buenos Aire
Hospital Privado de Rosario
RECRUITING
Rosario
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Eastern Health - Box Hill Hospital
RECRUITING
Box Hill
Cairns Hospital
ACTIVE_NOT_RECRUITING
Cairns
The Canberra Hospital
RECRUITING
Garran
The Alfred Hospital
RECRUITING
Melbourne
Fiona Stanley Hospital
RECRUITING
Perth
Westmead Hospital
RECRUITING
Westmead
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
Medizinische Universitaet Innsbruck
RECRUITING
Innsbruck
Universitaesklinikum St. Poelten
RECRUITING
Sankt Pölten
Belgium
AZ Sint-Jan Brugge
RECRUITING
Bruges
Universite Libre de Bruxelles (ULB) - Hopital Erasme
RECRUITING
Brussels
Antwerp University Hospital
RECRUITING
Edegem
UZ Leuven
RECRUITING
Leuven
Centre Hospitalier Regional de la Citadelle
RECRUITING
Liège
Brazil
Centro de Pesquisa NUPEC - Instituto Orizonti em Belo Horizonte
RECRUITING
Belo Horizonte
Complexo Hospitalar de Niterói (CHN-DASA)
RECRUITING
Niterói
CAPED - Centro Avancado de Pesquisa
RECRUITING
Ribeirão Preto
HCFMRP - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
RECRUITING
Ribeirão Preto
Cardiopulmonar da Bahia S. A. (Hospital Cardio Pulmonar)
RECRUITING
Salvador
Hospital Israelita Albert Einstein
RECRUITING
São Paulo
Instituto Dante Pazzanese de Cardiologia
RECRUITING
São Paulo
Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP
RECRUITING
São Paulo
PSEG Centro de Pesquisa Clinica S.A.
RECRUITING
São Paulo
Canada
Alberta Health Services - University of Calgary
RECRUITING
Calgary
McGill University Health Centre
RECRUITING
Montreal
University Health Network - Toronto General Hospital
RECRUITING
Toronto
Vancouver Coastal Health Research Institute
RECRUITING
Vancouver
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Rigshospitalet
RECRUITING
Copenhagen
France
AP-HP Hopital Henri Mondor
RECRUITING
Créteil
AP-HM - Hopital de la Timone
RECRUITING
Marseille
AP-HP Hopital Bichat - Claude Bernard
RECRUITING
Paris
CHU Rennes - Hopital Pontchaillou
RECRUITING
Rennes
CHU de Toulouse - Hopital Rangueil
RECRUITING
Toulouse
Germany
Charite Universitaetsmedizin Berlin
RECRUITING
Berlin
Universitaetsklinikum Essen
RECRUITING
Essen
Universitaetsklinikum Heidelberg
RECRUITING
Heidelberg
Universitaetsklinikum Wuerzburg
RECRUITING
Würzburg
Hungary
Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika
RECRUITING
Budapest
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah University Hospital, Ein Karem
RECRUITING
Jerusalem
Sheba Medical Center
RECRUITING
Tel Litwinsky
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
RECRUITING
Bologna
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna
RECRUITING
Cona
Azienda Ospedaliero-Universitaria Careggi
RECRUITING
Florence
Ospedale Policlinico San Martino IRCCS
RECRUITING
Genova
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Fondazione Toscana Gabriele Monasterio per la Ricerca Medica
RECRUITING
Pisa
Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
RECRUITING
Trieste
Japan
Kumamoto University Hospital
RECRUITING
Kumamoto
National Cerebral and Cardiovascular Center
RECRUITING
Osaka
The University of Tokyo Hospital
RECRUITING
Tokyo
Toyama University Hospital
RECRUITING
Toyama
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
RECRUITING
Mexico City
Netherlands
University Medical Center
RECRUITING
Groningen
Erasmus MC
RECRUITING
Rotterdam
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
New Zealand
New Zealand Clinical Research
RECRUITING
Auckland
New Zealand Clinical Research
RECRUITING
Christchurch
Norway
Oslo University Hospital - Rikshospitalet
RECRUITING
Oslo
Portugal
Centro Hospitalar Universitario de Lisboa Norte
RECRUITING
Lisbon
Centro Hospitalar Universitario do Porto
RECRUITING
Porto
Republic of Korea
Chonnam National University Hospital
RECRUITING
Gwangju
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Singapore
National Heart Centre
RECRUITING
Singapore
National University Hospital
RECRUITING
Singapore
Spain
Hospital Universitario de A Coruna
RECRUITING
A Coruña
Hospital Universitari de Bellvitge
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Puerta de Hierro
RECRUITING
Majadahonda
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Universitario Son Llatzer
RECRUITING
Palma De Mallorca
Sweden
Karolinska University Hospital
RECRUITING
Stockholm
University Hospital of Umea
RECRUITING
Umeå
Taiwan
Far Eastern Memorial Hospital
RECRUITING
New Taipei City
National Taiwan University Hospital
RECRUITING
Taipei
Taipai Veterans General Hospital
RECRUITING
Taipei
United Kingdom
Synexus Midlands Clinical Research Centre
ACTIVE_NOT_RECRUITING
Birmingham
Synexus Wales Clinical Research Centre
ACTIVE_NOT_RECRUITING
Cardiff
Synexus Scotland Clinical Research Centre
ACTIVE_NOT_RECRUITING
Glasgow
Synexus Hexham Clinical Research Centre
ACTIVE_NOT_RECRUITING
Hexham
Synexus Merseyside Clinical Research Centre
ACTIVE_NOT_RECRUITING
Liverpool
Richmond Pharmacology
RECRUITING
London
Synexus Manchester Clinical Research Centre
ACTIVE_NOT_RECRUITING
Manchester
Contact Information
Primary
Trial Manager at Intellia
medicalinformation@intelliatx.com
1-857-285-6200
Time Frame
Start Date: 2023-12-13
Estimated Completion Date: 2028-04
Participants
Target number of participants: 765
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