Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
NCT ID: NCT04119050
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
111 participants
INTERVENTIONAL
2019-08-15
2028-04-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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M281 administered every 4 weeks (double-blind period)
Participants will receive M281 administered every 4 weeks alternating with placebo every 4 weeks during the 24 weeks double-blind period.
M281
M281 injection administered as intravenous infusion
Placebo
Placebo administered as intravenous infusion
M281 administered every 2 weeks (double-blind period)
Participants will receive M281 administered every 2 weeks during the 24 weeks double-blind period.
M281
M281 injection administered as intravenous infusion
Placebo administered every 2 weeks (double-blind period)
Participants will receive M281 matching placebo administered every 2 weeks during the 24 weeks double-blind period.
Placebo
Placebo administered as intravenous infusion
M281 administered every 4 weeks (open-label extension period)
Participants will receive M281 administered every 4 weeks during the 144 weeks open-label extension period.
M281
M281 injection administered as intravenous infusion
M281 administered every 2 weeks (open-label extension period)
Participants will receive M281 administered every 2 weeks during the 144 weeks open-label extension period.
M281
M281 injection administered as intravenous infusion
Interventions
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M281
M281 injection administered as intravenous infusion
Placebo
Placebo administered as intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have been diagnosed with warm autoimmune hemolytic anemia (wAIHA) for at least 3 months, and are currently receiving treatment for wAIHA or have previously received treatment for wAIHA (treatment-naive participants are not eligible)
* Participants must be able to understand and voluntarily provide written informed consent to participate in the study and comply with all study procedures
Exclusion Criteria
* Participants must not have other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate
* Have been diagnosed with cold antibody autoimmune hemolytic anemia (AIHA), cold agglutinin syndrome, mixed type (that is, warm and cold) AIHA, or paroxysmal cold hemoglobinuria
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
Countries
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Central Contacts
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References
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Liu AP, Cheuk DK. Disease-modifying treatments for primary autoimmune haemolytic anaemia. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012493. doi: 10.1002/14651858.CD012493.pub2.
Related Links
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Other Identifiers
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MOM-M281-006
Identifier Type: OTHER
Identifier Source: secondary_id
2019-000720-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505321-14-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR108987
Identifier Type: -
Identifier Source: org_study_id