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Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
Sponsor: Janssen Research & Development, LLC
Summary
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
Official title: Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2019-08-15
Completion Date
2028-04-01
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
M281
M281 injection administered as intravenous infusion
Placebo
Placebo administered as intravenous infusion
Locations (171)
MemorialCare Medical Group
Fountain Valley, California, United States
University of Southern California
Los Angeles, California, United States
Compassionate Cancer Care
Riverside, California, United States
American Institute of Research
Whittier, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
GNP Research
Cooper City, Florida, United States
University of Florida College of Medicine
Gainesville, Florida, United States
21st Century Oncology
Jacksonville, Florida, United States
Lakes Research
Miami Lakes, Florida, United States
AdventHealth Cancer Institute
Orlando, Florida, United States
Children's Research Institute
St. Petersburg, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Alliance for Multispeciality Research
Merriam, Kansas, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Henry Ford Medical Center
Detroit, Michigan, United States
Research Medical Center
Kansas City, Missouri, United States
Montefiore Medical Center
Lake Success, New York, United States
Monter Cancer Center
Lake Success, New York, United States
Hematology Oncology Associates of Rockland
Nyack, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Taussig Cancer Insititute Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University- James Cancer Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Northwest Medical Specialists
Tacoma, Washington, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu, Brazil
Impar Servicos Hospitalares S/A - Hospital Brasilia
Brasília, Brazil
CTO Centro de Tratamento Oncologico Unidade Belem
Campinas, Brazil
Hospital Das Clinicas Da Universidade Federal De Goias
Goiânia, Brazil
Complexo Hospitalar de Niteroi
Niterói, Brazil
Oncoclinicas - Unidade OC Oncoclinicas Multihemo Ilha do Leite
Recife, Brazil
Nucleo de Oncologia da Bahia
Salvador, Brazil
Hospital Sao Rafael
Salvador, Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, Brazil
Hospital Santa Marcelina
Santo André, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, Brazil
Universidade Federal de Sao Paulo
São Paulo, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, Brazil
Beijing Chao-yang Hospital, Capital Medical University
Beijing, China
Peking University People's Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
West China Hospital of Sichuan University
Chengdu, China
Guangzhou First Municipal People's Hospital
Guangzhou, China
Hainan General Hospital
Haikou, China
First Affiliated Hospital Medical School of Zhejiang University
Hangzhou, China
Lanzhou University Second Hospital
Lanzhou, China
Jiangsu Province Hospital
Nanjing, China
Affiliated Hospital of Nantong University
Nantong, China
Shanghai Zhongshan Hospital
Shanghai, China
Huashan Hospital affiliated to Fudan University
Shanghai, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Tianjin Medical University General Hospital
Tianjin, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
Fakultni nemocnice Brno
Brno, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Ustav Hematologie A Krevni Transfuze
Prague, Czechia
Mansoura University Hospital
Al Mansurah, Egypt
Alexandria University
Alexandria, Egypt
Cairo university
Cairo, Egypt
National Cancer Institute Cairo
Cairo, Egypt
Ain Shams University Hospital
Cairo, Egypt
Nasser Institute Hospital for Research and Treatment
Cairo, Egypt
CHRU Hopital Amiens Picardie Sud
Amiens, France
ICH Hopital A. Morvan
Brest, France
CHU Dijon Bourgogne
Dijon, France
CHU Grenoble
La Tronche, France
CHU Nantes - Hotel Dieu
Nantes, France
CHU De Poitiers
Poitiers, France
Onkologische Schwerpunktpraxis
Berlin, Germany
Universitatsklinikum Essen
Essen, Germany
Rotkreuzklinikum München
München, Germany
General Hospital of Athens G Gennimatas
Athens, Greece
Laiko General Hospital of Athens
Athens, Greece
Attikon University General Hospital of Attica
Athens, Greece
University Hospital Of Larissa
Larissa, Greece
University General Hospital of Rio Patras
Pátrai, Greece
University General Hospital of Thessaloniki
Thessaloniki, Greece
Semmelweis Egyetem
Budapest, Hungary
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
Petz Aladar Megyei Oktato Korhaz
Gyõr, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, Hungary
Ha'Emek Medical Center
Afula, Israel
Soroka Medical Center
Beersheba, Israel
Rambam Health Care Campus
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Hadassah Medical Center
Jerusalem, Israel
Hospital Sanz Medical Center Laniado Hospital
Kiryat Tzanz, Israel
Rabin Medical Center, Beilinson Hospital
Petach Tikvah, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
PO C e G Mazzoni AST Ascoli Piceno
Ascoli Piceno, Italy
ASST Spedali Civili di Brescia
Brescia, Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi
Catania, Italy
AOU Policlinico G Rodolico S Marco
Catania, Italy