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: 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
COMPLETED
Fountain Valley
University of Southern California
COMPLETED
Los Angeles
Compassionate Cancer Care
COMPLETED
Riverside
American Institute of Research
COMPLETED
Whittier
Colorado
University of Colorado Anschutz Medical Campus
COMPLETED
Aurora
Florida
GNP Research
COMPLETED
Cooper City
University of Florida College of Medicine
COMPLETED
Gainesville
21st Century Oncology
COMPLETED
Jacksonville
Lakes Research
COMPLETED
Miami Lakes
AdventHealth Cancer Institute
COMPLETED
Orlando
Children's Research Institute
COMPLETED
St. Petersburg
Illinois
Rush University Medical Center
COMPLETED
Chicago
Kansas
Alliance for Multispeciality Research
COMPLETED
Merriam
Louisiana
Tulane University School of Medicine
COMPLETED
New Orleans
Michigan
Henry Ford Medical Center
COMPLETED
Detroit
Missouri
Research Medical Center
COMPLETED
Kansas City
North Carolina
Duke University Medical Center
RECRUITING
Durham
East Carolina University
RECRUITING
Greenville
New York
Montefiore Medical Center
COMPLETED
Lake Success
Monter Cancer Center
COMPLETED
Lake Success
Hematology Oncology Associates of Rockland
RECRUITING
Nyack
Ohio
Taussig Cancer Insititute Cleveland Clinic
COMPLETED
Cleveland
The Ohio State University- James Cancer Hospital
COMPLETED
Columbus
Pennsylvania
Children's Hospital of Philadelphia
COMPLETED
Philadelphia
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
West Penn Hospital
COMPLETED
Pittsburgh
Utah
University of Utah
COMPLETED
Salt Lake City
Washington
Northwest Medical Specialists
COMPLETED
Tacoma
Wisconsin
University of Wisconsin Carbone Cancer Center
COMPLETED
Madison
Other Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina de Botucatu
COMPLETED
Botucatu
Impar Servicos Hospitalares S/A - Hospital Brasilia
RECRUITING
Brasília
CTO Centro de Tratamento Oncologico Unidade Belem
RECRUITING
Campinas
Hospital Das Clinicas Da Universidade Federal De Goias
RECRUITING
Goiânia
Complexo Hospitalar de Niteroi
RECRUITING
Niterói
Oncoclinicas - Unidade OC Oncoclinicas Multihemo Ilha do Leite
COMPLETED
Recife
Hospital Sao Rafael
COMPLETED
Salvador
Nucleo de Oncologia da Bahia
COMPLETED
Salvador
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
COMPLETED
Santo André
Hospital Santa Marcelina
COMPLETED
Santo André
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
COMPLETED
São José Do Rio Preto
Hospital Das Clinicas Da Faculdade De Medicina Da USP
RECRUITING
São Paulo
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
COMPLETED
São Paulo
Universidade Federal de Sao Paulo
COMPLETED
São Paulo
China
Beijing Chao-yang Hospital, Capital Medical University
COMPLETED
Beijing
Peking University People s Hospital
COMPLETED
Beijing
The First Hospital of Jilin University
COMPLETED
Changchun
West China Hospital of Sichuan University
RECRUITING
Chengdu
Guangzhou First Municipal People's Hospital
RECRUITING
Guangzhou
Hainan General Hospital
COMPLETED
Haikou
First Affiliated Hospital Medical School of Zhejiang University
RECRUITING
Hangzhou
Lanzhou University Second Hospital
COMPLETED
Lanzhou
Jiangsu Province Hospital
RECRUITING
Nanjing
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Huashan Hospital affiliated to Fudan University
RECRUITING
Shanghai
Shanghai Zhongshan Hospital
COMPLETED
Shanghai
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of Xian Jiaotong University
RECRUITING
Xi'an
Egypt
Mansoura University Hospital
COMPLETED
Al Mansurah
Alexandria University Hospital
COMPLETED
Alexandria
Ain Shams University Hospital
COMPLETED
Cairo
Cairo university
COMPLETED
Cairo
Nasser institute Hospital
COMPLETED
Cairo
National Cancer Institute
COMPLETED
Cairo
France
ICH Hopital A. Morvan
COMPLETED
Brest
CHU Dijon Bourgogne
RECRUITING
Dijon
CHU Grenoble
COMPLETED
La Tronche
CHU Nantes - Hotel Dieu
COMPLETED
Nantes
CHU De Poitiers
COMPLETED
Poitiers
CHRU Hopital Sud
RECRUITING
Rennes
Germany
Onkologische Schwerpunktpraxis
RECRUITING
Berlin
Universitatsklinikum Essen
RECRUITING
Essen
Rotkreuzklinikum München
COMPLETED
München
Greece
Attikon University General Hospital of Attica
COMPLETED
Athens
General Hospital of Athens G Gennimatas
COMPLETED
Athens
Laiko General Hospital of Athens
COMPLETED
Athens
University Hospital Of Larissa
COMPLETED
Larissa
University General Hospital of Rio Patras
COMPLETED
Pátrai
University General Hospital of Thessaloniki
COMPLETED
Thessaloniki
Hungary
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
COMPLETED
Budapest
Semmelweis Egyetem
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont
RECRUITING
Debrecen
Petz Aladar Megyei Oktato Korhaz
RECRUITING
Gyõr
Somogy Megyei Kaposi Mor Oktato Korhaz
COMPLETED
Kaposvár
Israel
Ha'Emek Medical Center
RECRUITING
Afula
Soroka Medical Center
RECRUITING
Beersheba
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
COMPLETED
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Hospital Sanz Medical Center Laniado Hospital
COMPLETED
Kiryat Tzanz
Rabin Medical Center, Beilinson Hospital
RECRUITING
Petach Tikvah
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
PO C e G Mazzoni AST Ascoli Piceno
COMPLETED
Ascoli Piceno
ASST Spedali Civili di Brescia
COMPLETED
Brescia
AOU Policlinico G Rodolico S Marco
RECRUITING
Catania
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi
COMPLETED
Catania
Azienda Ospedaliero Universitaria Careggi
COMPLETED
Florence
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori
COMPLETED
Monza
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
RECRUITING
Novara
Fondazione Policlinico Universitario A Gemelli IRCCS
RECRUITING
Roma
Umberto I Policlinico di Roma
COMPLETED
Roma
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
COMPLETED
Torino
Azienda Ulss 8 Berica- Ospedale Di Vicenza
COMPLETED
Vicenza
Japan
Fukushima Medical University Hospital
COMPLETED
Fukushima
Saitama Medical University Hospital
RECRUITING
Iruma-gun
St Marianna University Hospital
COMPLETED
Kanagawa
Japan Community Health care Organization Kyushu Hospital
COMPLETED
Kitakyusyu-shi
Yamanashi Prefectural Central Hospital
RECRUITING
Kofu
Ogaki Municipal Hospital
COMPLETED
Ōgaki
Sapporo Medical University Hospital
COMPLETED
Sapporo
Tohoku University Hospital
RECRUITING
Sendai
Osaka University Hospital
RECRUITING
Suita
Toyama Prefectural Central Hospital
COMPLETED
Toyama
Wakayama Medical University Hospital
RECRUITING
Wakayama
Tottori University Hospital
RECRUITING
Yonago
Malaysia
Hospital Ampang
RECRUITING
Ampang
Hospital Sultanah Aminah
COMPLETED
Johor Bharu
Hospital Queen Elizabeth
COMPLETED
Kota Kinabalu
University Malaya Medical Centre
COMPLETED
Kuala Lumpur
Hospital Tengku Ampuan Afzan
COMPLETED
Kuantan
Hospital Umum Sarawak
RECRUITING
Kuching
Sunway Medical Centre
COMPLETED
Petaling Jaya
Netherlands
Academic Medical Centre Amsterdam
COMPLETED
Amsterdam
Amsterdam Universitair Medische Centra Locatie Vrije Universiteit Medisch Centrum
RECRUITING
Amsterdam
Maastricht Universitair Medisch Centrum
COMPLETED
Maastricht
Poland
Interhem
COMPLETED
Bialystok
Klinika Hematologii i Transplantologii, UCK
COMPLETED
Gdansk
Pratia Onkologia Katowice
RECRUITING
Katowice
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
RECRUITING
Lodz
Szpital Wojewodzki w Opolu
COMPLETED
Opole
MTZ Clinical Research Powered by Pratia
RECRUITING
Warsaw
Republic of Korea
Kyungpook National University Hospital
COMPLETED
Daegu
Chungnam National University Hospital
COMPLETED
Daejeon
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Spain
Hosp. Univ. Principe de Asturias
COMPLETED
Alcalá De Henares
Hosp. Univ. Germans Trias I Pujol
RECRUITING
Badalona
Hosp Clinic de Barcelona
RECRUITING
Barcelona
Complejo Asistencial Univ. de Burgos
COMPLETED
Burgos
Hosp Reina Sofia
RECRUITING
Córdoba
Hosp. Univ. de Gran Canaria Dr. Negrin
COMPLETED
Las Palmas De Gran Canaria
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hosp. Univ. Infanta Leonor
RECRUITING
Madrid
Hosp. Univ. La Paz
RECRUITING
Madrid
Hosp. Univ. Ramon Y Cajal
RECRUITING
Madrid
Hospital Clinico San Carlos
COMPLETED
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Hosp Regional Univ de Malaga
COMPLETED
Málaga
Hosp Virgen de La Victoria
COMPLETED
Málaga
Hosp. Virgen Del Rocio
RECRUITING
Málaga
Hosp. Son Llatzer
COMPLETED
Palma De Mallorca
Clinica Univ. de Navarra
COMPLETED
Pamplona
Hosp. Quiron Madrid Pozuelo
RECRUITING
Pozuelo De Alarcón
Hosp. Univ. I Politecni La Fe
COMPLETED
Valencia
Hosp. Univ. Miguel Servet
COMPLETED
Zaragoza
Ukraine
Cherkassy Regional Oncology Dispensary, Department of Hematology
COMPLETED
Cherkassy
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
COMPLETED
Dnipro
Kyiv City Clinical Hospital #9, Department of infectious diseases
TERMINATED
Kyiv
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
TERMINATED
Kyiv
Ternopil University Hospital of Ternopil Regional Council
TERMINATED
Ternopil
United Kingdom
Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
Liverpool University Hospitals NHS Foundation Trust
RECRUITING
Liverpool
Barts Health NHS Trust
COMPLETED
London
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
University Hospitals Plymouth NHS Trust
RECRUITING
Plymouth
University Hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2019-08-15
Estimated Completion Date: 2028-04-10
Participants
Target number of participants: 111
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