A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Start Date
2/27/2025
Completion Date
3/16/2028
Summary
Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously \[SC\]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it. The participants will be treated with mezagitamab for up to 6 months. During the study, participants will visit their study clinic several times. Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Mezagitamab
Placebo
Conditions
Locations
USC Norris Comprehensive Cancer Center - Keck Medicine of USC
Los Angeles, California 90033
United States
Rocky Mountain Cancer Center
Denver, Colorado 80218
United States
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia 20007
United States
Emory University
Atlanta, Georgia 30308
United States
The University of Iowa
Iowa City, Iowa 52242
United States
University Of Louisville Brown Cancer Center
Louisville, Kentucky 40202
United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland 20817
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655
United States
Duke University Hospital
Durham, North Carolina 27710
United States
East Carolina University
Greenville, North Carolina 27837
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program
Philadelphia, Pennsylvania 19104
United States
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania 19140
United States
Baylor College of Medicine
Houston, Texas 77030
United States
Virginia Oncology Associates
Norfolk, Virginia 23502
United States
University of Washingto
Seattle, Washington 98109
United States
Versiti Wisconsin, Inc
Milwaukee, Wisconsin 53226
United States
Canberra Hospital
Garran, Australian Capital Territory 2605
Australia
Concord Repatriation General Hospital
Concord, New South Wales 2139
Australia
St George Hospital
Kogarah, New South Wales 2217
Australia
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
Liverpool, New South Wales 2170
Australia
Westmead Hospital
Westmead, New South Wales 2145
Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
Monash University - Australian Centre for Blood Diseases (ACBD)
Melbourne, Victoria 3004
Australia
The Alfred Hospital
Melbourne, Victoria 3005
Australia
Fiona Stanley Hospital
Murdoch, Western Australia 6150
Australia
Perth Blood Institute
West Perth, Western Australia 6005
Australia
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, Sofia-Grad 1606
Bulgaria
Medical Center "Fama Medical"
Plovdiv, 4002
Bulgaria
UMHAT Sv. Ivan Rilski
Sofia, 1431
Bulgaria
UMHAT SofiaMed, OOD
Sofia, 1750
Bulgaria
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, 6003
Bulgaria
Peking Union Medical College Hospital
Beijing, Beijing Municipality 100730
China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510080
China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi 530021
China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei 050031
China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hebei 430022
China
Henan Cancer Hospital
Zhengzhou, Henan 450004
China
The First Affiliated Hospital of Soochow University - Shizijie Campus
Suzhou, Jiangsu 215006
China
The First Affiliated Hospital of Nanchang University - Donghu Campus
Nanchang, Jiangxi 330006
China
Shengjing Hospital of China Medical University - Nanhu Campus
Shenyang, Liaoning 110004
China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi 710068
China
Qilu Hospital of Shandong University
Jinan, Shandong 250012
China
Jinshan Hospital of Fudan University
Shanghai, Shanghai Municipality 201508
China
West China Hospital Sichuan University
Chengdu, Sichuan 610041
China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
Tianjin, Tianjin Municipality 300020
China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan 650101
China
Zhejiang Provincial Hospital of Chinese Medicine - Main
Hangzhou, Zhejiang 310006
China
Clinical Hospital Centar Zagreb
Zagreb, 10000
Croatia
Chu Dijon - Bourgogne
Dijon, Bourgogne-Franche-Comté 1000
France
Hospital Henri Mondor
Créteil, 94000
France
Olympion General Clinic & Rehabilitation Center
Pátrai, 264 43
Greece
General Hospital of Thessaloniki George Papanikolaou
Thessaloniki, 570 10
Greece
Queen Mary Hospital
Hong Kong, Pok Fu Lam
Hong Kong
Azienda Ospedaliera Universitaria Federico II
Naples, Campania 80131
Italy
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
Rome, Lazio oo610
Italy
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
Catania, Sicily 95122
Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, 40123
Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
Milan, 20162
Italy
Fondazione IRCCS San Gerardo Dei Tintori
Monza, 20900
Italy
A.O.U. Maggiore della Carita
Novara, 28100
Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, oo133
Italy
AOU Citta della Salute e della Scienza di Torino
Torino, 10126
Italy
Azienda sanitaria universitaria Giuliano Isontina
Trieste, 34129
Italy
Azienda ULSS 8 Berica - Ospedale San Bortolo
Vicenza, 36100
Italy
Chiba Aoba Municipal Hospital
Chuo-ku, Chiba 260-0852
Japan
Chibaken Saiseikai Narashino Hospital
Narashino-shi, Chiba 275-8580
Japan
National Hospital Organization Mito Medical Center
Ibaraki, Higashiibaraki-gun 311-3193
Japan
Yokohama City University Medical Center
Yokohama, Kanagawa 232-0024
Japan
Tohoku University Hospital
Sendai, Miyagi 980-8574
Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka 573-1191
Japan
Hematology Ohta Clinic,Shinsaibashi
Osaka, Osaka 542-0081
Japan
Osaka University Hospital
Suita-shi, Osaka 565-0871
Japan
Saitama Medical University Hospital
Iruma-gun, Saitama 350-0495
Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo 113-8655
Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo 173-8610
Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku, Tokyo 130-0022
Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi 400-8506
Japan
Erasmus Medical Center, Department of Hematology
Rotterdam, South Holland 3015 GD
Netherlands
Hagaziekenhuis
The Hague, South Holland 2545AA
Netherlands
Universitetet i Bergen
Bergen, 5021
Norway
IN-VIVO sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-048
Poland
Instytut Hematologii i Transfuzjologii Klinika Zaburzen Hemostazy i Chorob Wewnetrznych
Warsaw, Masovian Voivodeship 02-776
Poland
Pratia Onkologia Katowice - PRATIA
Katowice, Silesian Voivodeship 40-523
Poland
N. Copernicus Provincial MCOT in Lodz
Lodz, Łódź Voivodeship 93-513
Poland
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
South Korea
Kyungpook National University Hospital
Daegu, 41944
South Korea
Seoul National University Hospital (SNUH)
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Korea University Anam Hospital
Seoul, 2841
South Korea
Asan Medical Center
Seoul, 5505
South Korea
Hospital Universitario Fundacion Alcorcon
Alcorcón, Mardrid 28922
Spain
Hospital General Universitario Gregorio Maranon
Madrid, Mardrid 28007
Spain
Hospital Universitario 12 de Octubre
Madrid, Mardrid 28041
Spain
Hospital Universitario De Salaman
Salamanca, 37007
Spain
Hospital Universitario Virgen del Rocio
Seville, 41013
Spain
Karolinska Universitetssjukhuset
Huddinge, Stockholm County 14186
Sweden
Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology
Mamak, Ankara 6620
Turkey (Türkiye)
Aydin Adnan Menderes University Medical Faculty-Hematology Department
Efeler, Aydın 9100
Turkey (Türkiye)
Cerrahpasa Tip Fakultesi
Edirne, 22030
Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi Hastanesi
Edirne, 22030
Turkey (Türkiye)
Sakarya University Education and Research Hospital
Sakarya, 54290
Turkey (Türkiye)
University Hospitals of Leicester NHS Trust
Leicester, East Midlands LE1 5WW
United Kingdom
Southampton General Hospital
Southampton, Hampshire SO16 6YD
United Kingdom
Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust
Southwark, London SE1 9RT
United Kingdom
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, Merseyside L7 8XP
United Kingdom
Greater Glasgow Health Board
Glasgow, Scotland G312ER
United Kingdom
University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire ST4 6QG
United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, Yorkshire LS9 TF
United Kingdom
Barts Health NHS Trust, Royal London Hospital
London, E11BB
United Kingdom
University College London Hospitals
London, NW1 2PG
United Kingdom
Imperial College Healthcare NHS Trust
London, W12 0HS
United Kingdom