Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Oct 4, 2019
Trial Information
Current as of July 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called M281 for adults with a condition known as warm autoimmune hemolytic anemia (wAIHA). This condition occurs when the body's immune system mistakenly attacks and destroys its own red blood cells, leading to anemia, which means not having enough healthy red blood cells to carry oxygen throughout the body. The main goal of the study is to see how effective and safe M281 is for people with this condition.
To participate in the trial, individuals must be at least 18 years old and have been diagnosed with wAIHA for at least three months. They should also be currently receiving treatment for this condition or have received treatment in the past. Unfortunately, pregnant or breastfeeding individuals cannot join the study, nor can those with certain other related blood disorders. Participants will have the opportunity to receive the new treatment and will be closely monitored by the research team throughout the trial. This is an important step in finding better ways to help manage wAIHA and improve the quality of life for those affected by it.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • Participants greater than or equal to (\>=)18 years of age
- • 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 be pregnant or breastfeeding
- • 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
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Philadelphia, Pennsylvania, United States
Durham, North Carolina, United States
Philadelphia, Pennsylvania, United States
New Orleans, Louisiana, United States
Vicenza, , Italy
Chicago, Illinois, United States
Brooklyn, New York, United States
Toronto, Ontario, Canada
Kansas City, Missouri, United States
Salt Lake City, Utah, United States
Pittsburgh, Pennsylvania, United States
Gainesville, Florida, United States
Madison, Wisconsin, United States
Tacoma, Washington, United States
Madrid, , Spain
Gainesville, Florida, United States
Oklahoma City, Oklahoma, United States
Greenville, North Carolina, United States
Tel Aviv, , Israel
Detroit, Michigan, United States
Amsterdam, , Netherlands
Eindhoven, , Netherlands
Seoul, , Korea, Republic Of
Groningen, , Netherlands
Fukushima, , Japan
Liverpool, , United Kingdom
Toyama, , Japan
Seoul, , Korea, Republic Of
Sendai, , Japan
Shanghai, , China
Tacoma, Washington, United States
Jerusalem, , Israel
Essen, , Germany
Poitiers, , France
Lake Success, New York, United States
Nyack, New York, United States
Kuala Lumpur, , Malaysia
Firenze, , Italy
Chengdu, , China
Alexandria, , Egypt
Ampang, , Malaysia
Suzhou, , China
Nanjing, , China
Yonago, , Japan
Riverside, California, United States
Praha 10, , Czechia
Alcalá De Henares, , Spain
Riverside, California, United States
Madrid, , Spain
Beer Sheva, , Israel
Mykolaiv, , Ukraine
Budapest, , Hungary
Jerusalem, , Israel
Brno, , Czechia
Whittier, California, United States
London, , United Kingdom
Berlin, , Germany
Den Haag, , Netherlands
Petach Tikvah, , Israel
Firenze, , Italy
Sao Paulo, , Brazil
Daegu, , Korea, Republic Of
Larissa, , Greece
Aurora, Colorado, United States
Salvador, , Brazil
Shanghai, , China
Changchun, , China
Firenze, , Italy
Maastricht, , Netherlands
Sao Paulo, , Brazil
Warszawa, , Poland
Majadahonda, , Spain
Kuantan, , Malaysia
La Tronche, , France
Glendale, Arizona, United States
Suita, , Japan
Kuching, , Malaysia
Debrecen, , Hungary
Miami Lakes, Florida, United States
Haifa, , Israel
Monza, , Italy
Canterbury, , United Kingdom
München, , Germany
Orlando, Florida, United States
Roma, , Italy
Nantong, , China
Aurora, Colorado, United States
Columbus, Ohio, United States
Wuhan, , China
Madrid, , Spain
Athens, , Greece
Opole, , Poland
Milan, , Italy
Xi'an, , China
Kaposvar, , Hungary
Daejeon, , Korea, Republic Of
Amiens, , France
Sao Paulo, , Brazil
Budapest, , Hungary
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Wakayama, , Japan
Roma, , Italy
Tianjin, , China
Brescia, , Italy
Madrid, , Spain
Jacksonville, Florida, United States
Katowice, , Poland
Oxford, , United Kingdom
Badalona, , Spain
Barcelona, , Spain
Lanzhou, , China
London, , United Kingdom
Afula, , Israel
Ogaki, , Japan
Pamplona, , Spain
Johor Bahru, , Malaysia
Sao Paulo, , Brazil
Valencia, , Spain
Iruma Gun, , Japan
Xi'an, , China
Kecskemét, , Hungary
Nantes, , France
Sao Paulo, , Brazil
Palermo, , Italy
Córdoba, , Spain
Nyíregyháza, , Hungary
Brescia, , Italy
Buffalo, New York, United States
Bialystok, , Poland
Dijon, , France
Salvador, , Brazil
Budapest, , Hungary
Oxford, Oxfordshire, United Kingdom
Southampton, , United Kingdom
Brest Cedex 2, , France
Haikou, , China
Pozuelo De Alarcon, , Spain
Goiânia, , Brazil
Torino, , Italy
London, , United Kingdom
Netanya, , Israel
Cairo, , Egypt
Málaga, , Spain
Palma De Mallorca, , Spain
Catania, , Italy
Las Palmas De Gran Canaria, , Spain
Zaragoza, , Spain
Dnipro, , Ukraine
Sao Paulo, , Brazil
Liverpool, , United Kingdom
Niterói, , Brazil
Kyiv, , Ukraine
Catania, , Italy
Wuhan, , China
Novara, , Italy
Sapporo, , Japan
Cleveland, Ohio, United States
Santo André, , Brazil
Gyõr, , Hungary
Torino, , Italy
Vicenza, , Italy
Kanagawa, , Japan
Plymouth, , United Kingdom
Cairo, , Egypt
Boynton Beach, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Saint Petersburg, Florida, United States
Lake Success, New York, United States
Chapel Hill, North Carolina, United States
Greenville, North Carolina, United States
Laurinburg, North Carolina, United States
Belem, , Brazil
Botucatu, , Brazil
Goiania, , Brazil
Recife, , Brazil
Salvador, , Brazil
Sao Jose Do Rio Preto, , Brazil
Beijing Shi, , China
Beijing Shi, , China
Guangzhou Shi, , China
Hangzhou, , China
Shanghai, , China
Praha 2, , Czechia
Athens, , Greece
Athens, , Greece
Patras, , Greece
Thessaloniki, , Greece
Pécs, , Hungary
Jerusalem, , Israel
Ascoli Piceno, , Italy
Catania, , Italy
Milano, , Italy
Roma, , Italy
Kitakyusyu Shi, , Japan
Kofu Shi, , Japan
Nagoya Shi, , Japan
Sungai Buloh, , Malaysia
Gdansk, , Poland
Wałbrzych, , Poland
łódź, , Poland
Barcelona, , Spain
Burgos, , Spain
Málaga, , Spain
Cherkassy, , Ukraine
Kyiv, , Ukraine
Ternopil, , Ukraine
Leeds, , United Kingdom
Novara, , Italy
Merida, , Mexico
Petaling Jaya, , Malaysia
Fountain Valley, California, United States
Cooper City, Florida, United States
Brasília, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Johor Bahru, , Malaysia
Kota Kinabalu, , Malaysia
Warszawa, , Poland
Sao Paulo, , Brazil
Tlajomulco De Zúñiga, , Mexico
Botucatu, , Brazil
Niteroi, , Brazil
Cooper City, Florida, United States
Mansoura, , Egypt
São José Do Rio Preto, , Brazil
Sao Jose Do Rio Preto, , Brazil
Goiânia, , Brazil
Recife, , Brazil
Mexico, , Mexico
Mexico, , Mexico
Ciudad De Mexico, , Mexico
Gainesville, Florida, United States
Gainesville, Florida, United States
Saint Petersburg, Florida, United States
Praha 2, , Czechia
Merriam, Kansas, United States
Sao Paulo, , Brazil
Sao Jose Do Rio Preto, , Brazil
Monza, , Italy
Barcelona, , Spain
Kansas City, Missouri, United States
Niterói, , Brazil
Rennes, , France
Kiryat Tzanz, , Israel
Ascoli Piceno, , Italy
Catania, , Italy
Amsterdam, , Netherlands
Roma, , Italy
Kanagawa, , Japan
Brasilia, , Brazil
Campinas, , Brazil
Recife, , Brazil
Santo Andre, , Brazil
Cairo, , Egypt
Cairo, , Egypt
Wakayama, , Japan
Budapest, , Hungary
Sendai, , Japan
Kanagawa, , Japan
Toyama, , Japan
Sao Paulo, , Brazil
Beijing Shi, , China
Hangzhou, , China
Barcelona, , Spain
Córdoba, , Spain
Suita, , Japan
łódź, , Poland
Málaga, , Spain
Cleveland, Ohio, United States
Katowice, , Poland
Santo Andre, , Brazil
Málaga, , Spain
Sao Jose Do Rio Preto, , Brazil
Sao Paulo, , Brazil
Fukushima, , Japan
Lodz, , Poland
Salvador, , Brazil
Sao Paulo, , Brazil
Athens, , Greece
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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