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ACTIVE NOT RECRUITING
NCT04119050
PHASE2/PHASE3

Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

2026-03-16

Healthy Volunteers

No

Interventions

DRUG

M281

M281 injection administered as intravenous infusion

DRUG

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 Hospital

Alexandria, Egypt

Cairo university

Cairo, Egypt

Ain Shams University Hospital

Cairo, Egypt

National Cancer Institute

Cairo, Egypt

Nasser institute Hospital

Cairo, Egypt

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

CHRU Hopital Sud

Rennes, 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

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

Novara, Italy

Umberto I Policlinico di Roma

Roma, Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, Italy

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Torino, Italy

Azienda Ulss 8 Berica- Ospedale Di Vicenza

Vicenza, Italy

Fukushima Medical University Hospital

Fukushima, Japan

Saitama Medical University Hospital

Iruma-gun, Japan

St Marianna University Hospital

Kanagawa, Japan

Japan Community Health care Organization Kyushu Hospital

Kitakyusyu-Shi, Japan

Yamanashi Prefectural Central Hospital

Kofu, Japan

Ogaki Municipal Hospital

Ōgaki, Japan

Sapporo Medical University Hospital

Sapporo, Japan

Tohoku University Hospital

Sendai, Japan

Osaka University Hospital

Suita, Japan

Toyama Prefectural Central Hospital

Toyama, Japan

Wakayama Medical University Hospital

Wakayama, Japan

Tottori University Hospital

Yonago, Japan

Hospital Ampang

Ampang, Malaysia

Hospital Sultanah Aminah

Johor Bharu, Malaysia

Hospital Queen Elizabeth

Kota Kinabalu, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, Malaysia

Hospital Umum Sarawak

Kuching, Malaysia

Sunway Medical Centre

Petaling Jaya, Malaysia

Amsterdam Universitair Medische Centra Locatie Vrije Universiteit Medisch Centrum

Amsterdam, Netherlands

Academic Medical Centre Amsterdam

Amsterdam, Netherlands

Maastricht Universitair Medisch Centrum

Maastricht, Netherlands

Interhem

Bialystok, Poland

Klinika Hematologii i Transplantologii, UCK

Gdansk, Poland

Pratia Onkologia Katowice

Katowice, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

Lodz, Poland

Szpital Wojewodzki w Opolu

Opole, Poland

MTZ Clinical Research Powered by Pratia

Warsaw, Poland

Kyungpook National University Hospital

Daegu, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Samsung Medical Center

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hosp. Univ. Principe de Asturias

Alcalá de Henares, Spain

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Complejo Asistencial Univ. de Burgos

Burgos, Spain

Hosp Reina Sofia

Córdoba, Spain

Hosp. Univ. de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, Spain

Hosp. Univ. Infanta Leonor

Madrid, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Univ. La Paz

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Hosp Regional Univ de Malaga

Málaga, Spain

Hosp Virgen de La Victoria

Málaga, Spain

Hosp. Virgen Del Rocio

Málaga, Spain

Hosp. Son Llatzer

Palma de Mallorca, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, Spain

Hosp. Univ. I Politecni La Fe

Valencia, Spain

Hosp. Univ. Miguel Servet

Zaragoza, Spain

Cherkassy Regional Oncology Dispensary, Department of Hematology

Cherkassy, Ukraine

Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

Dnipro, Ukraine

Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

Kyiv, Ukraine

Kyiv City Clinical Hospital #9, Department of infectious diseases

Kyiv, Ukraine

Ternopil University Hospital of Ternopil Regional Council

Ternopil, Ukraine

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Barts Health NHS Trust

London, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom