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
Who is this study for? Adult patients with Warm Autoimmune Hemolytic Anemia
What treatments are being studied? M281
Status: Active_not_recruiting
Location: See all (168) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
MemorialCare Medical Group
Fountain Valley
University of Southern California
Los Angeles
Compassionate Cancer Care
Riverside
American Institute of Research
Whittier
Colorado
University of Colorado Anschutz Medical Campus
Aurora
Florida
GNP Research
Cooper City
University of Florida College of Medicine
Gainesville
21st Century Oncology
Jacksonville
Lakes Research
Miami Lakes
AdventHealth Cancer Institute
Orlando
Children's Research Institute
St. Petersburg
Illinois
Rush University Medical Center
Chicago
Kansas
Alliance for Multispeciality Research
Merriam
Louisiana
Tulane University School of Medicine
New Orleans
Michigan
Henry Ford Medical Center
Detroit
Missouri
Research Medical Center
Kansas City
North Carolina
Duke University Medical Center
Durham
East Carolina University
Greenville
New York
Montefiore Medical Center
Lake Success
Monter Cancer Center
Lake Success
Hematology Oncology Associates of Rockland
Nyack
Ohio
Taussig Cancer Insititute Cleveland Clinic
Cleveland
The Ohio State University- James Cancer Hospital
Columbus
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
Hospital of the University of Pennsylvania
Philadelphia
West Penn Hospital
Pittsburgh
Utah
University of Utah
Salt Lake City
Washington
Northwest Medical Specialists
Tacoma
Wisconsin
University of Wisconsin Carbone Cancer Center
Madison
Other Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu
Impar Servicos Hospitalares S/A - Hospital Brasilia
Brasília
CTO Centro de Tratamento Oncologico Unidade Belem
Campinas
Hospital Das Clinicas Da Universidade Federal De Goias
Goiânia
Complexo Hospitalar de Niteroi
Niterói
Oncoclinicas - Unidade OC Oncoclinicas Multihemo Ilha do Leite
Recife
Hospital Sao Rafael
Salvador
Nucleo de Oncologia da Bahia
Salvador
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André
Hospital Santa Marcelina
Santo André
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José Do Rio Preto
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo
Universidade Federal de Sao Paulo
São Paulo
China
Beijing Chao-yang Hospital, Capital Medical University
Beijing
Peking University People's Hospital
Beijing
The First Hospital of Jilin University
Changchun
West China Hospital of Sichuan University
Chengdu
Guangzhou First Municipal People's Hospital
Guangzhou
Hainan General Hospital
Haikou
First Affiliated Hospital Medical School of Zhejiang University
Hangzhou
Lanzhou University Second Hospital
Lanzhou
Jiangsu Province Hospital
Nanjing
Affiliated Hospital of Nantong University
Nantong
Huashan Hospital affiliated to Fudan University
Shanghai
Shanghai Zhongshan Hospital
Shanghai
The First Affiliated Hospital of Soochow University
Suzhou
Tianjin Medical University General Hospital
Tianjin
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan
The First Affiliated Hospital of Xian Jiaotong University
Xi'an
Egypt
Mansoura University Hospital
Al Mansurah
Alexandria University Hospital
Alexandria
Ain Shams University Hospital
Cairo
Cairo university
Cairo
Nasser institute Hospital
Cairo
National Cancer Institute
Cairo
France
ICH Hopital A. Morvan
Brest
CHU Dijon Bourgogne
Dijon
CHU Grenoble
La Tronche
CHU Nantes - Hotel Dieu
Nantes
CHU De Poitiers
Poitiers
CHRU Hopital Sud
Rennes
Germany
Onkologische Schwerpunktpraxis
Berlin
Universitatsklinikum Essen
Essen
Rotkreuzklinikum München
München
Greece
Attikon University General Hospital of Attica
Athens
General Hospital of Athens G Gennimatas
Athens
Laiko General Hospital of Athens
Athens
University Hospital Of Larissa
Larissa
University General Hospital of Rio Patras
Pátrai
University General Hospital of Thessaloniki
Thessaloniki
Hungary
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
Budapest
Semmelweis Egyetem
Budapest
Debreceni Egyetem Klinikai Kozpont
Debrecen
Petz Aladar Megyei Oktato Korhaz
Gyõr
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár
Israel
Ha'Emek Medical Center
Afula
Soroka Medical Center
Beersheba
Rambam Health Care Campus
Haifa
Hadassah Medical Center
Jerusalem
Shaare Zedek Medical Center
Jerusalem
Hospital Sanz Medical Center Laniado Hospital
Kiryat Tzanz
Rabin Medical Center, Beilinson Hospital
Petach Tikvah
Tel Aviv Sourasky Medical Center
Tel Aviv
Italy
PO C e G Mazzoni AST Ascoli Piceno
Ascoli Piceno
ASST Spedali Civili di Brescia
Brescia
AOU Policlinico G Rodolico S Marco
Catania
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi
Catania
Azienda Ospedaliero Universitaria Careggi
Florence
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan
Fondazione IRCCS San Gerardo dei Tintori
Monza
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
Novara
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma
Umberto I Policlinico di Roma
Roma
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino
Azienda Ulss 8 Berica- Ospedale Di Vicenza
Vicenza
Japan
Fukushima Medical University Hospital
Fukushima
Saitama Medical University Hospital
Iruma-gun
St Marianna University Hospital
Kanagawa
Japan Community Health care Organization Kyushu Hospital
Kitakyusyu-shi
Yamanashi Prefectural Central Hospital
Kofu
Ogaki Municipal Hospital
Ōgaki
Sapporo Medical University Hospital
Sapporo
Tohoku University Hospital
Sendai
Osaka University Hospital
Suita
Toyama Prefectural Central Hospital
Toyama
Wakayama Medical University Hospital
Wakayama
Tottori University Hospital
Yonago
Malaysia
Hospital Ampang
Ampang
Hospital Sultanah Aminah
Johor Bharu
Hospital Queen Elizabeth
Kota Kinabalu
University Malaya Medical Centre
Kuala Lumpur
Hospital Tengku Ampuan Afzan
Kuantan
Hospital Umum Sarawak
Kuching
Sunway Medical Centre
Petaling Jaya
Netherlands
Academic Medical Centre Amsterdam
Amsterdam
Amsterdam Universitair Medische Centra Locatie Vrije Universiteit Medisch Centrum
Amsterdam
Maastricht Universitair Medisch Centrum
Maastricht
Poland
Interhem
Bialystok
Klinika Hematologii i Transplantologii, UCK
Gdansk
Pratia Onkologia Katowice
Katowice
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz
Szpital Wojewodzki w Opolu
Opole
MTZ Clinical Research Powered by Pratia
Warsaw
Republic of Korea
Kyungpook National University Hospital
Daegu
Chungnam National University Hospital
Daejeon
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Spain
Hosp. Univ. Principe de Asturias
Alcalá De Henares
Hosp. Univ. Germans Trias I Pujol
Badalona
Hosp Clinic de Barcelona
Barcelona
Complejo Asistencial Univ. de Burgos
Burgos
Hosp Reina Sofia
Córdoba
Hosp. Univ. de Gran Canaria Dr. Negrin
Las Palmas De Gran Canaria
Hosp. Univ. 12 de Octubre
Madrid
Hosp. Univ. Infanta Leonor
Madrid
Hosp. Univ. La Paz
Madrid
Hosp. Univ. Ramon Y Cajal
Madrid
Hospital Clinico San Carlos
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
Hosp Regional Univ de Malaga
Málaga
Hosp Virgen de La Victoria
Málaga
Hosp. Virgen Del Rocio
Málaga
Hosp. Son Llatzer
Palma De Mallorca
Clinica Univ. de Navarra
Pamplona
Hosp. Quiron Madrid Pozuelo
Pozuelo De Alarcón
Hosp. Univ. I Politecni La Fe
Valencia
Hosp. Univ. Miguel Servet
Zaragoza
Ukraine
Cherkassy Regional Oncology Dispensary, Department of Hematology
Cherkassy
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
Dnipro
Kyiv City Clinical Hospital #9, Department of infectious diseases
Kyiv
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
Kyiv
Ternopil University Hospital of Ternopil Regional Council
Ternopil
United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds
Liverpool University Hospitals NHS Foundation Trust
Liverpool
Barts Health NHS Trust
London
Oxford University Hospitals NHS Foundation Trust
Oxford
University Hospitals Plymouth NHS Trust
Plymouth
University Hospital Southampton NHS Foundation Trust
Southampton
Time Frame
Start Date: 2019-08-15
Completion Date: 2028-04-01
Participants
Target number of participants: 118
Treatments
Experimental: 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.
Experimental: M281 administered every 2 weeks (double-blind period)
Participants will receive M281 administered every 2 weeks during the 24 weeks double-blind period.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC