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Brief Title: A Study of AG-946 in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS)
Official Title: A Phase 2a/2b, Open-label, Proof of Concept (Phase 2a) and Double-blind, Randomized, Placebo-Controlled (Phase 2b), Multicenter, Efficacy, and Safety Study of AG-946 in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes
Study ID: NCT05490446
Brief Summary: This purpose of this study is to establish proof of concept of AG-946 in participants with LR-MDS in Phase 2a and to compare the effect of AG-946 versus placebo and to detect a dose response for erythroid response in participants with LR-MDS in Phase 2b.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Innovative Clinical Research Institute Whittier, Lakewood, California, United States
David Geffen School of Medicine at UCLA, Los Angeles, California, United States
Emad Ibrahim, MD, Inc., Redlands, California, United States
Mayo Clinic Jacksonville - PPDS, Jacksonville, Florida, United States
Edward H. Kaplan MD & Associates, Skokie, Illinois, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, Long Island City, New York, United States
Duke Adult Blood and Marrow Clinic, Durham, North Carolina, United States
Monash Health, Monash Medical Centre, Clayton, Victoria, Australia
Ordensklinikum Linz GmbH Elisabethinen, Linz, Oberösterreich, Austria
Fakultni nemocnice Ostrava, Ostrava, , Czechia
Hôpital de La Conception, Marseille, Bouches-du-Rhône, France
CHU Angers, Angers, Maine-et-Loire, France
CHRU Lille, Lille, , France
Hôpital Saint Louis, Paris, , France
Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany
Universitatsklinikum Dusseldorf, Düsseldorf, Nordrhein-Westfalen, Germany
Universitatsklinikum Leipzig, Leipzig, Sachsen, Germany
University Hospital of Alexandroupolis, Alexandroupolis, , Greece
Attikon University General Hospital, Athens, , Greece
University General Hospital of Patras, Patras, , Greece
Hippokration Hospital, Thessaloniki, , Greece
Shaare Zedek Medical Center, Jerusalem, , Israel
Tel Aviv Sourasky Medical Center PPDS, Tel Aviv, , Israel
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, Lombardia, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia, Lombardia, Italy
Istituto Clinico Humanitas, Rozzano, Lombardia, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Piemonte, Italy
Fondazione PTV Policlinico Tor Vergata, Roma, , Italy
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Asan Medical Center - PPDS, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
MTZ Clinical Research Powered by PRATIA - PPDS, Warszawa, Mazowieckie, Poland
Pratia Onkologia Katowice - PRATIA - PPDS, Katowice, Slaskie, Poland
SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn, Warminsko-mazurskie, Poland
C.H. Regional Reina Sofia - PPDS, Cordoba, , Spain
Hospital Universitario La Paz - PPDS, Madrid, , Spain
Hospital Universitario HM Sanchinarro - CIOCC, Madrid, , Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico, Salamanca, , Spain
Hospital Universitario Virgen del Rocio - PPDS, Sevilla, , Spain
Aberdeen Royal Infirmary - PPDS, Aberdeen, Aberdeen City, United Kingdom
Western General Hospital Edinburgh - PPDS, Edinburgh, , United Kingdom
Kings College Hospital, London, , United Kingdom
Churchill Hospital-NHS Oxford, Oxford, , United Kingdom
Name: Medical Medical Affairs
Affiliation: Agios Pharmaceuticals, Inc.
Role: STUDY_CHAIR