Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia (ENERGY)

Last Updated   June 20, 2024 - 21:00

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 2
    The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety.
  • Sites
    171 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. Regional Univ. de Malaga
COMPLETED
Spain Málaga Hosp. Virgen Del Rocio
RECRUITING
Spain Málaga Hosp. Virgen de La Victoria
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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