New drug trial aims to tame rare blood disorder

NCT ID NCT04119050

Summary

This study is testing an investigational drug called M281 (nipocalimab) for adults with warm autoimmune hemolytic anemia (wAIHA), a condition where the immune system mistakenly attacks red blood cells. The main goal is to see if the drug can safely and durably improve hemoglobin levels, reduce the need for steroid medications, and lessen fatigue. The trial involves a 24-week blinded period comparing the drug to a placebo, followed by a long-term extension where all participants receive the active drug.

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes NO responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • 21st Century Oncology

    Jacksonville, Florida, 32204, United States

  • AOU Policlinico G Rodolico S Marco

    Catania, 95125, Italy

  • ASST Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Academic Medical Centre Amsterdam

    Amsterdam, 1105 AZ, Netherlands

  • AdventHealth Cancer Institute

    Orlando, Florida, 32804, United States

  • Affiliated Hospital of Nantong University

    Nantong, 226001, China

  • Ain Shams University Hospital

    Cairo, 1181, Egypt

  • Alexandria University Hospital

    Alexandria, 21131, Egypt

  • Alliance for Multispeciality Research

    Merriam, Kansas, 66204, United States

  • American Institute of Research

    Whittier, California, 90603, United States

  • Amsterdam Universitair Medische Centra Locatie Vrije Universiteit Medisch Centrum

    Amsterdam, 1081 HV Amsterdam, Netherlands

  • Asan Medical Center

    Seoul, 138-040, South Korea

  • Attikon University General Hospital of Attica

    Athens, 12462, Greece

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi

    Catania, 95122, Italy

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134, Italy

  • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

    Novara, 28100, Italy

  • Azienda Ulss 8 Berica- Ospedale Di Vicenza

    Vicenza, 36100, Italy

  • Barts Health NHS Trust

    London, E1 2ES, United Kingdom

  • Beijing Chao-yang Hospital, Capital Medical University

    Beijing, 100020, China

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060 650, Brazil

  • CHRU Hopital Sud

    Rennes, 35200, France

  • CHU De Poitiers

    Poitiers, 86021, France

  • CHU Dijon Bourgogne

    Dijon, 21000, France

  • CHU Grenoble

    La Tronche, 38700, France

  • CHU Nantes - Hotel Dieu

    Nantes, 44093, France

  • CTO Centro de Tratamento Oncologico Unidade Belem

    Campinas, 13083-887, Brazil

  • Cairo university

    Cairo, 11211, Egypt

  • Cherkassy Regional Oncology Dispensary, Department of Hematology

    Cherkassy, 18009, Ukraine

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Research Institute

    St. Petersburg, Florida, 33701, United States

  • Chungnam National University Hospital

    Daejeon, 35015, South Korea

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Compassionate Cancer Care

    Riverside, California, 92501, United States

  • Complejo Asistencial Univ. de Burgos

    Burgos, 09006, Spain

  • Complexo Hospitalar de Niteroi

    Niterói, 24020-096, Brazil

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

    Budapest, 1097, Hungary

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

    Dnipro, 49102, Ukraine

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • East Carolina University

    Greenville, North Carolina, 27834, United States

  • Fakultni nemocnice Brno

    Brno, 625 00, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34, Czechia

  • First Affiliated Hospital Medical School of Zhejiang University

    Hangzhou, 310003, China

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900, Italy

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168, Italy

  • Fukushima Medical University Hospital

    Fukushima, 960 1295, Japan

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

    São José do Rio Preto, 15090 000, Brazil

  • GNP Research

    Cooper City, Florida, 33024, United States

  • General Hospital of Athens G Gennimatas

    Athens, 115 27, Greece

  • Guangzhou First Municipal People's Hospital

    Guangzhou, 510180, China

  • Ha'Emek Medical Center

    Afula, 1834111, Israel

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Hainan General Hospital

    Haikou, 570311, China

  • Hematology Oncology Associates of Rockland

    Nyack, New York, 10960, United States

  • Henry Ford Medical Center

    Detroit, Michigan, 48202, United States

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Regional Univ de Malaga

    Málaga, 29010, Spain

  • Hosp Reina Sofia

    Córdoba, 14004, Spain

  • Hosp Virgen de La Victoria

    Málaga, 29010, Spain

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223, Spain

  • Hosp. Son Llatzer

    Palma de Mallorca, 07198, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026, Spain

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031, Spain

  • Hosp. Univ. La Paz

    Madrid, 28046, Spain

  • Hosp. Univ. Miguel Servet

    Zaragoza, 50009, Spain

  • Hosp. Univ. Principe de Asturias

    Alcalá de Henares, 28805, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hosp. Univ. de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, 35010, Spain

  • Hosp. Virgen Del Rocio

    Málaga, 29010, Spain

  • Hospital Ampang

    Ampang, 68000, Malaysia

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403 000, Brazil

  • Hospital Das Clinicas Da Universidade Federal De Goias

    Goiânia, 74605-020, Brazil

  • Hospital Queen Elizabeth

    Kota Kinabalu, 88200, Malaysia

  • Hospital Santa Marcelina

    Santo André, 09060-870, Brazil

  • Hospital Sanz Medical Center Laniado Hospital

    Kiryat Tzanz, 4244916, Israel

  • Hospital Sao Rafael

    Salvador, 41253 190, Brazil

  • Hospital Sultanah Aminah

    Johor Bharu, 80100, Malaysia

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100, Malaysia

  • Hospital Umum Sarawak

    Kuching, 93586, Malaysia

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222, Spain

  • Hospital das Clínicas da Faculdade de Medicina de Botucatu

    Botucatu, 18610-070, Brazil

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Huashan Hospital affiliated to Fudan University

    Shanghai, 200040, China

  • ICH Hopital A. Morvan

    Brest, 29609, France

  • Impar Servicos Hospitalares S/A - Hospital Brasilia

    Brasília, 71681-603, Brazil

  • Interhem

    Bialystok, 15-732, Poland

  • Japan Community Health care Organization Kyushu Hospital

    Kitakyusyu-Shi, 806-8501, Japan

  • Jiangsu Province Hospital

    Nanjing, 210029, China

  • Klinika Hematologii i Transplantologii, UCK

    Gdansk, 80-214, Poland

  • Kyiv City Clinical Hospital #9, Department of infectious diseases

    Kyiv, 04112, Ukraine

  • Kyungpook National University Hospital

    Daegu, 41944, South Korea

  • Laiko General Hospital of Athens

    Athens, 11527, Greece

  • Lakes Research

    Miami Lakes, Florida, 33014, United States

  • Lanzhou University Second Hospital

    Lanzhou, 730030, China

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LF9 7TF, United Kingdom

  • Liverpool University Hospitals NHS Foundation Trust

    Liverpool, L7 8XP, United Kingdom

  • MTZ Clinical Research Powered by Pratia

    Warsaw, 02-172, Poland

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX, Netherlands

  • Mansoura University Hospital

    Al Mansurah, 35516, Egypt

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

    Kyiv, 02091, Ukraine

  • MemorialCare Medical Group

    Fountain Valley, California, 92708, United States

  • Montefiore Medical Center

    Lake Success, New York, 11042, United States

  • Monter Cancer Center

    Lake Success, New York, 11042, United States

  • Nasser institute Hospital

    Cairo, 12655, Egypt

  • National Cancer Institute

    Cairo, 11976, Egypt

  • Northwest Medical Specialists

    Tacoma, Washington, 98405, United States

  • Nucleo de Oncologia da Bahia

    Salvador, 40170-110, Brazil

  • Ogaki Municipal Hospital

    Ōgaki, 503-8502, Japan

  • Oncoclinicas - Unidade OC Oncoclinicas Multihemo Ilha do Leite

    Recife, 50040-000, Brazil

  • Onkologische Schwerpunktpraxis

    Berlin, 10707, Germany

  • Osaka University Hospital

    Suita, 565 0871, Japan

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE, United Kingdom

  • PO C e G Mazzoni AST Ascoli Piceno

    Ascoli Piceno, 63100, Italy

  • Peking University People's Hospital

    Beijing, 100044, China

  • Petz Aladar Megyei Oktato Korhaz

    Gyõr, 9023, Hungary

  • Pratia Onkologia Katowice

    Katowice, 40 519, Poland

  • Rabin Medical Center, Beilinson Hospital

    Petach Tikvah, 49100, Israel

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Research Medical Center

    Kansas City, Missouri, 64132, United States

  • Rotkreuzklinikum München

    München, 80634, Germany

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Saitama Medical University Hospital

    Iruma-gun, 350-0495, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sapporo Medical University Hospital

    Sapporo, 060-8543, Japan

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Shanghai Zhongshan Hospital

    Shanghai, 200032, China

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 050, Brazil

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400, Hungary

  • Soroka Medical Center

    Beersheba, 8410101, Israel

  • St Marianna University Hospital

    Kanagawa, 216 8511, Japan

  • Sunway Medical Centre

    Petaling Jaya, 47500, Malaysia

  • Szpital Wojewodzki w Opolu

    Opole, 45-061, Poland

  • Taussig Cancer Insititute Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • Ternopil University Hospital of Ternopil Regional Council

    Ternopil, 46002, Ukraine

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006, China

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Ohio State University- James Cancer Hospital

    Columbus, Ohio, 43210, United States

  • Tianjin Medical University General Hospital

    Tianjin, 300052, China

  • Tohoku University Hospital

    Sendai, 980 8574, Japan

  • Tottori University Hospital

    Yonago, 683-8504, Japan

  • Toyama Prefectural Central Hospital

    Toyama, 930 8550, Japan

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112, United States

  • Umberto I Policlinico di Roma

    Roma, 00161, Italy

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430022, China

  • Universidade Federal de Sao Paulo

    São Paulo, 04024-002, Brazil

  • Universitatsklinikum Essen

    Essen, 45147, Germany

  • University General Hospital of Rio Patras

    Pátrai, 26504, Greece

  • University General Hospital of Thessaloniki

    Thessaloniki, 54636, Greece

  • University Hospital Of Larissa

    Larissa, 41110, Greece

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO166YD, United Kingdom

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH, United Kingdom

  • University Malaya Medical Centre

    Kuala Lumpur, 50603, Malaysia

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Florida College of Medicine

    Gainesville, Florida, 32610, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792, United States

  • Ustav Hematologie A Krevni Transfuze

    Prague, 128 00, Czechia

  • Wakayama Medical University Hospital

    Wakayama, 641 8510, Japan

  • West China Hospital of Sichuan University

    Chengdu, 610041, China

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224, United States

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

    Lodz, 93 510, Poland

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-0027, Japan

Conditions

Explore the condition pages connected to this study.