Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia (ENERGY)
Last Updated July 17, 2024 - 21:06
OVERVIEW
-
Gender
all -
Age
years -
Phase
phase 2The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety. -
Sites
sites -
Status
Recruiting
SUMMARY
The study consists of a 24-week double-blind, placebo control period, a 144-week open-label extension period and follow-up period of 8 weeks after last study drug administration. Eligible participants will be randomized to placebo or nipocalimab (2 dose levels) during the double-blind period and nipocalimab (2 dose levels) during the open-label extension period.
CONDITIONS
- Warm Autoimmune Hemolytic Anemia
ELIGIBILITY
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
DETAILS
The study consists of a 24-week double-blind, placebo control period, a 144-week open-label extension period and follow-up period of 8 weeks after last study drug administration. Eligible participants will be randomized to placebo or nipocalimab (2 dose levels) during the double-blind period and nipocalimab (2 dose levels) during the open-label extension period.
LOCATIONS
Locations in:
United States, United Kingdom, Ukraine, Spain, South Korea, Poland, Netherlands, Malaysia, Japan, Italy, Israel, Hungary, Greece, Germany, France, Egypt, Czechia, China, Brazil
| Country (19) | City or Province (171) | Status |
| United States | Aurora, CO University of Colorado Anschutz Medical Campus |
RECRUITING
|
| United States | Chicago, IL Rush University Medical Center |
COMPLETED
|
| United States | Cleveland, OH Taussig Cancer Insititute Cleveland Clinic |
RECRUITING
|
| United States | Columbus, OH The Ohio State University- James Cancer Hospital |
RECRUITING
|
| United States | Cooper City, FL GNP Research |
RECRUITING
|
| United States | Detroit, MI Henry Ford Medical Center |
COMPLETED
|
| United States | Durham, NC Duke University Medical Center |
RECRUITING
|
| United States | Fountain Valley, CA MemorialCare Medical Group |
RECRUITING
|
| United States | Gainesville, FL University of Florida College of Medicine |
RECRUITING
|
| United States | Greenville, NC East Carolina University |
RECRUITING
|
| United States | Jacksonville, FL 21st Century Oncology |
COMPLETED
|
| United States | Kansas City, MO Research Medical Center |
COMPLETED
|
| United States | Lake Success, NY Montefiore Medical Center |
RECRUITING
|
| United States | Lake Success, NY Monter Cancer Center |
COMPLETED
|
| United States | Los Angeles, CA University of Southern California |
RECRUITING
|
| United States | Madison, WI University of Wisconsin Carbone Cancer Center |
COMPLETED
|
| United States | Merriam, KS Alliance for Multispeciality Research |
RECRUITING
|
| United States | Miami Lakes, FL Lakes Research |
COMPLETED
|
| United States | New Orleans, LA Tulane University School of Medicine |
RECRUITING
|
| United States | Nyack, NY Hematology Oncology Associates of Rockland |
RECRUITING
|
| United States | Orlando, FL AdventHealth Cancer Institute |
RECRUITING
|
| United States | Philadelphia, PA Children's Hospital of Philadelphia |
COMPLETED
|
| United States | Philadelphia, PA Hospital of the University of Pennsylvania |
RECRUITING
|
| United States | Pittsburgh, PA West Penn Hospital |
COMPLETED
|
| United States | Riverside, CA Compassionate Cancer Care |
COMPLETED
|
| United States | Saint Petersburg, FL Children's Research Institute |
COMPLETED
|
| United States | Salt Lake City, UT University of Utah |
COMPLETED
|
| United States | Tacoma, WA Northwest Medical Specialists |
RECRUITING
|
| United States | Whittier, CA American Institute of Research |
COMPLETED
|
| United Kingdom | Leeds, WYK Leeds Teaching Hospitals NHS Trust |
RECRUITING
|
| United Kingdom | Liverpool, MSY Liverpool University Hospitals NHS Foundation Trust |
RECRUITING
|
| United Kingdom | London Barts Health NHS Trust |
RECRUITING
|
| United Kingdom | Oxford, OXF Oxford University Hospitals NHS Foundation Trust |
RECRUITING
|
| United Kingdom | Plymouth University Hospitals Plymouth NHS Trust |
RECRUITING
|
| United Kingdom | Southampton University Hospital Southampton NHS Foundation Trust |
RECRUITING
|
| Ukraine | Cherkassy Cherkassy Regional Oncology Dispensary, Department of Hematology |
COMPLETED
|
| Ukraine | Dnipro Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4 |
COMPLETED
|
| Ukraine | Kyiv Kyiv City Clinical Hospital #9, Department of infectious diseases |
TERMINATED
|
| Ukraine | Kyiv Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies' |
TERMINATED
|
| Ukraine | Ternopil Ternopil University Hospital of Ternopil Regional Council |
TERMINATED
|
| Spain | Alcalá de Henares, MD Hosp. Univ. Principe de Asturias |
RECRUITING
|
| Spain | Badalona, BA Hosp. Univ. Germans Trias I Pujol |
RECRUITING
|
| Spain | Barcelona, BA Hosp Clinic de Barcelona |
RECRUITING
|
| Spain | Burgos, BU Complejo Asistencial Univ. de Burgos |
COMPLETED
|
| Spain | Córdoba Hosp Reina Sofia |
RECRUITING
|
| Spain | Las Palmas de Gran Canaria, PM Hosp. Univ. de Gran Canaria Dr. Negrin |
COMPLETED
|
| Spain | Madrid, MD Hosp. Univ. 12 de Octubre |
RECRUITING
|
| Spain | Madrid, MD Hosp. Univ. Infanta Leonor |
RECRUITING
|
| Spain | Madrid, MD Hosp. Univ. La Paz |
RECRUITING
|
| Spain | Madrid, MD Hosp. Univ. Ramon Y Cajal |
RECRUITING
|
| Spain | Madrid, MD Hospital Clinico San Carlos |
RECRUITING
|
| Spain | Majadahonda, MD Hospital Universitario Puerta de Hierro Majadahonda |
RECRUITING
|
| Spain | Málaga Hosp Virgen de La Victoria |
RECRUITING
|
| Spain | Málaga Hosp. Regional Univ. de Malaga |
COMPLETED
|
| Spain | Málaga Hosp. Virgen Del Rocio |
RECRUITING
|
| Spain | Palma de Mallorca Hosp. Son Llatzer |
RECRUITING
|
| Spain | Pamplona Clinica Univ. de Navarra |
RECRUITING
|
| Spain | Pozuelo de Alarcon, MD Hosp. Quiron Madrid Pozuelo |
RECRUITING
|
| Spain | Valencia, VC Hosp. Univ. I Politecni La Fe |
RECRUITING
|
| Spain | Zaragoza, ZR Hosp. Univ. Miguel Servet |
RECRUITING
|
| South Korea | Daegu Kyungpook National University Hospital |
RECRUITING
|
| South Korea | Daejeon Chungnam National University Hospital |
RECRUITING
|
| South Korea | Seoul Asan Medical Center |
RECRUITING
|
| South Korea | Seoul Samsung Medical Center |
RECRUITING
|
| Poland | Bialystok Interhem |
RECRUITING
|
| Poland | Gdansk Klinika Hematologii i Transplantologii, UCK |
COMPLETED
|
| Poland | Katowice Pratia Onkologia Katowice |
RECRUITING
|
| Poland | Opole Szpital Wojewodzki w Opolu |
RECRUITING
|
| Poland | Warszawa MTZ Clinical Research Powered by Pratia |
RECRUITING
|
| Poland | Łódź Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi |
RECRUITING
|
| Netherlands | Amsterdam Academic Medical Centre Amsterdam |
RECRUITING
|
| Netherlands | Amsterdam Amsterdam Universitair Medische Centra Locatie Vrije Universiteit Medisch Centrum |
RECRUITING
|
| Netherlands | Maastricht, LI Maastricht Universitair Medisch Centrum |
COMPLETED
|
| Malaysia | Ampang Hospital Ampang |
RECRUITING
|
| Malaysia | Johor Bahru, JH Hospital Sultanah Aminah |
RECRUITING
|
| Malaysia | Kota Kinabalu, SB Hospital Queen Elizabeth |
RECRUITING
|
| Malaysia | Kuala Lumpur University Malaya Medical Centre |
RECRUITING
|
| Malaysia | Kuantan, PH Hospital Tengku Ampuan Afzan |
RECRUITING
|
| Malaysia | Kuching, SR Hospital Umum Sarawak |
RECRUITING
|
| Malaysia | Petaling Jaya, SL Sunway Medical Centre |
RECRUITING
|
| Japan | Fukushima Fukushima Medical University Hospital |
RECRUITING
|
| Japan | Iruma-gun, 11 Saitama Medical University Hospital |
RECRUITING
|
| Japan | Kanagawa, 14 St Marianna University Hospital |
RECRUITING
|
| Japan | Kitakyusyu-Shi Japan Community Health care Organization Kyushu Hospital |
RECRUITING
|
| Japan | Kofu-Shi Yamanashi Prefectural Central Hospital |
RECRUITING
|
| Japan | Ogaki Ogaki Municipal Hospital |
RECRUITING
|
| Japan | Sapporo, 01 Sapporo Medical University Hospital |
RECRUITING
|
| Japan | Sendai, 04 Tohoku University Hospital |
RECRUITING
|
| Japan | Suita, 27 Osaka University Hospital |
RECRUITING
|
| Japan | Toyama, 16 Toyama Prefectural Central Hospital |
RECRUITING
|
| Japan | Wakayama Wakayama Medical University Hospital |
RECRUITING
|
| Japan | Yonago, 31 Tottori University Hospital |
RECRUITING
|
| Italy | Ascoli Piceno PO C e G Mazzoni AST Ascoli Piceno |
RECRUITING
|
| Italy | Brescia ASST Spedali Civili di Brescia |
RECRUITING
|
| Italy | Catania AOU Policlinico G Rodolico S Marco |
RECRUITING
|
| Italy | Catania Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi |
RECRUITING
|
| Italy | Firenze Azienda Ospedaliero Universitaria Careggi |
RECRUITING
|
| Italy | Milan Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico |
RECRUITING
|
| Italy | Monza Fondazione IRCCS San Gerardo dei Tintori |
RECRUITING
|
| Italy | Novara Azienda Ospedaliero Universitaria Maggiore della Carita di Novara |
RECRUITING
|
| Italy | Roma Fondazione Policlinico Universitario A Gemelli IRCCS |
RECRUITING
|
| Italy | Roma Umberto I Policlinico di Roma |
COMPLETED
|
| Italy | Torino Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino |
RECRUITING
|
| Italy | Vicenza Azienda Ulss 8 Berica- Ospedale Di Vicenza |
RECRUITING
|
| Israel | Afula Ha'Emek Medical Center |
RECRUITING
|
| Israel | Beer Sheva Soroka Medical Center |
RECRUITING
|
| Israel | Haifa, H Rambam Health Care Campus |
RECRUITING
|
| Israel | Jerusalem Hadassah Medical Center |
RECRUITING
|
| Israel | Jerusalem Shaare Zedek Medical Center |
RECRUITING
|
| Israel | Kiryat Tzanz Hospital Sanz Medical Center Laniado Hospital |
RECRUITING
|
| Israel | Petach Tikvah Rabin Medical Center, Beilinson Hospital |
RECRUITING
|
| Israel | Tel Aviv Tel Aviv Sourasky Medical Center |
RECRUITING
|
| Hungary | Budapest Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely |
RECRUITING
|
| Hungary | Budapest Semmelweis Egyetem |
RECRUITING
|
| Hungary | Debrecen Debreceni Egyetem Klinikai Kozpont |
RECRUITING
|
| Hungary | Gyõr Petz Aladar Megyei Oktato Korhaz |
RECRUITING
|
| Hungary | Kaposvar Somogy Megyei Kaposi Mor Oktato Korhaz |
COMPLETED
|
| Greece | Athens Attikon University General Hospital of Attica |
RECRUITING
|
| Greece | Athens General Hospital of Athens 'G. Gennimatas' |
RECRUITING
|
| Greece | Athens Laiko General Hospital of Athens |
COMPLETED
|
| Greece | Larissa University Hospital Of Larissa |
RECRUITING
|
| Greece | Patras University General Hospital of Rio Patras |
COMPLETED
|
| Greece | Thessaloniki University General Hospital of Thessaloniki |
COMPLETED
|
| Germany | Berlin, BE Onkologische Schwerpunktpraxis |
RECRUITING
|
| Germany | Essen, NW Universitatsklinikum Essen |
RECRUITING
|
| Germany | München Rotkreuzklinikum München |
COMPLETED
|
| France | Brest Cedex 2 ICH Hopital A. Morvan |
COMPLETED
|
| France | Dijon CHU Dijon Bourgogne |
RECRUITING
|
| France | La Tronche CHU Grenoble |
RECRUITING
|
| France | Nantes CHU Nantes - Hotel Dieu |
RECRUITING
|
| France | Poitiers CHU De Poitiers |
RECRUITING
|
| France | Rennes CHRU Hopital Sud |
RECRUITING
|
| Egypt | Alexandria Alexandria University Hospital |
RECRUITING
|
| Egypt | Cairo Ain Shams University Hospital |
RECRUITING
|
| Egypt | Cairo Cairo university |
RECRUITING
|
| Egypt | Cairo Nasser institute Hospital |
RECRUITING
|
| Egypt | Cairo National Cancer Institute |
RECRUITING
|
| Egypt | Mansoura Mansoura University Hospital |
RECRUITING
|
| Czechia | Brno Fakultni nemocnice Brno |
RECRUITING
|
| Czechia | Praha 10 Fakultni nemocnice Kralovske Vinohrady |
RECRUITING
|
| Czechia | Praha 2 Ustav Hematologie A Krevni Transfuze |
RECRUITING
|
| China | Beijing Shi, 11 Beijing Chao-yang Hospital, Capital Medical University |
RECRUITING
|
| China | Beijing Shi, 11 Peking University People s Hospital |
COMPLETED
|
| China | Changchun The First Hospital of Jilin University |
COMPLETED
|
| China | Chengdu West China Hospital of Sichuan University |
RECRUITING
|
| China | Guangzhou Shi Guangzhou First Municipal People's Hospital |
RECRUITING
|
| China | Haikou Hainan General Hospital |
COMPLETED
|
| China | Hangzhou First Affiliated Hospital Medical School of Zhejiang University |
RECRUITING
|
| China | Lanzhou Lanzhou University Second Hospital |
RECRUITING
|
| China | Nanjing Jiangsu Province Hospital |
RECRUITING
|
| China | Nantong Affiliated Hospital of Nantong University |
RECRUITING
|
| China | ShangHai, 31 Shanghai Zhongshan Hospital |
COMPLETED
|
| China | Shanghai, 31 Huashan Hospital affiliated to Fudan University |
RECRUITING
|
| China | Suzhou The First Affiliated Hospital of Soochow University |
RECRUITING
|
| China | Tianjin, 12 Tianjin Medical University General Hospital |
RECRUITING
|
| China | Wuhan Union Hospital Tongji Medical College of Huazhong University of Science and Technology |
RECRUITING
|
| China | Xi'An The First Affiliated Hospital of Xian Jiaotong University |
RECRUITING
|
| Brazil | Botucatu, SP Hospital das Clínicas da Faculdade de Medicina de Botucatu |
RECRUITING
|
| Brazil | Brasilia Impar Servicos Hospitalares S/A - Hospital Brasilia |
RECRUITING
|
| Brazil | Campinas, SP CTO Centro de Tratamento Oncologico Unidade Belem |
RECRUITING
|
| Brazil | Goiânia Hospital Das Clinicas Da Universidade Federal De Goias |
RECRUITING
|
| Brazil | Niterói Complexo Hospitalar de Niteroi |
RECRUITING
|
| Brazil | Recife, PE Oncoclinicas - Unidade OC Oncoclinicas Multihemo Ilha do Leite |
RECRUITING
|
| Brazil | Salvador, BA Hospital Sao Rafael |
RECRUITING
|
| Brazil | Salvador, BA Nucleo de Oncologia da Bahia |
RECRUITING
|
| Brazil | Santo Andre, SP Hospital Santa Marcelina |
RECRUITING
|
| Brazil | Santo André, SP CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia |
RECRUITING
|
| Brazil | Sao Jose Do Rio Preto, SP Centro Integrado de Pesquisa -Hospital de Base de São José do Rio Preto |
RECRUITING
|
| Brazil | Sao Paulo, SP Hospital Das Clinicas Da Faculdade De Medicina Da USP |
RECRUITING
|
| Brazil | Sao Paulo, SP Hospital Sirio Libanes Sao Paulo |
RECRUITING
|
| Brazil | Sao Paulo, SP Universidade Federal de Sao Paulo |
RECRUITING
|
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