Actively Recruiting
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Led by Takeda · Updated on 2026-05-08
171
Participants Needed
112
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with ITP for at least 12 months
- Prior response to an ITP therapy excluding thrombopoietin receptor agonists, achieving platelet count ≥50,000/µL
- Insufficient response or intolerance to at least one first-line and one second-line ITP therapy
- Mean platelet count less than 30,000/µL
- Stable dose and frequency of standard-of-care ITP treatment for at least 4 weeks before first study dose if continuing treatment
- Negative pregnancy test if participant has potential for pregnancy
You will not qualify if you...
- Diagnosis of secondary ITP
- Thrombotic or embolic event within 12 months before consent
- History of splenectomy
- Active hepatitis B, hepatitis C, or HIV infection
- History of malignancy within 5 years except treated non-melanoma skin cancer or cervical carcinoma in situ
- Serious medical or psychiatric illness interfering with treatment completion
- Anti-CD20 treatment within 12 months before screening with specific timing and CD19+ count restrictions
- Monoclonal or polyclonal antibody for immunomodulation within 6 months before first dose
- Prior exposure to mezagitamab or investigational agent within 4 weeks or 5 half-lives before first dose
- Use of anticoagulants within 3 weeks before first dose
- Live or live-attenuated vaccine within 4 weeks before first dose or planned during trial
- Use of specified immunosuppressive agents within defined timeframes before first dose
- Use of certain immunoglobulin or thrombocytopenia treatments within 4 weeks before consent or expected use between screening and first dose
- History of severe allergic or anaphylactic reactions to mezagitamab or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 112 locations
1
USC Norris Comprehensive Cancer Center - Keck Medicine of USC
Los Angeles, California, United States, 90033
Actively Recruiting
2
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
Withdrawn
3
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
4
Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
5
The University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
University Of Louisville Brown Cancer Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
7
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States, 20817
Not Yet Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
10
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
11
East Carolina University
Greenville, North Carolina, United States, 27837
Actively Recruiting
12
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
13
Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
15
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
16
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
17
University of Washingto
Seattle, Washington, United States, 98109
Not Yet Recruiting
18
Versiti Wisconsin, Inc
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
19
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Actively Recruiting
20
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Actively Recruiting
21
St George Hospital
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
22
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
23
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
24
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Not Yet Recruiting
25
Monash University - Australian Centre for Blood Diseases (ACBD)
Melbourne, Victoria, Australia, 3004
Actively Recruiting
26
The Alfred Hospital
Melbourne, Victoria, Australia, 3005
Actively Recruiting
27
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
28
Perth Blood Institute
West Perth, Western Australia, Australia, 6005
Actively Recruiting
29
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, Sofia-Grad, Bulgaria, 1606
Actively Recruiting
30
Medical Center "Fama Medical"
Plovdiv, Bulgaria, 4002
Actively Recruiting
31
UMHAT Sv. Ivan Rilski
Sofia, Bulgaria, 1431
Actively Recruiting
32
UMHAT SofiaMed, OOD
Sofia, Bulgaria, 1750
Actively Recruiting
33
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, Bulgaria, 6003
Actively Recruiting
34
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
35
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
36
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
37
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050031
Actively Recruiting
38
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hebei, China, 430022
Actively Recruiting
39
Henan Cancer Hospital
Zhengzhou, Henan, China, 450004
Actively Recruiting
40
The First Affiliated Hospital of Soochow University - Shizijie Campus
Suzhou, Jiangsu, China, 215006
Actively Recruiting
41
The First Affiliated Hospital of Nanchang University - Donghu Campus
Nanchang, Jiangxi, China, 330006
Actively Recruiting
42
Shengjing Hospital of China Medical University - Nanhu Campus
Shenyang, Liaoning, China, 110004
Actively Recruiting
43
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China, 710068
Actively Recruiting
44
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
45
Jinshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201508
Actively Recruiting
46
West China Hospital Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
47
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
48
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650101
Actively Recruiting
49
Zhejiang Provincial Hospital of Chinese Medicine - Main
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
50
Clinical Hospital Centar Zagreb
Zagreb, Croatia, 10000
Not Yet Recruiting
51
Chu Dijon - Bourgogne
Dijon, Bourgogne-Franche-Comté, France, 1000
Not Yet Recruiting
52
Hospital Henri Mondor
Créteil, France, 94000
Not Yet Recruiting
53
Olympion General Clinic & Rehabilitation Center
Pátrai, Greece, 264 43
Actively Recruiting
54
General Hospital of Thessaloniki George Papanikolaou
Thessaloniki, Greece, 570 10
Actively Recruiting
55
Queen Mary Hospital
Hong Kong, Pok Fu Lam, Hong Kong
Actively Recruiting
56
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, Italy, 80131
Not Yet Recruiting
57
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
Rome, Lazio, Italy, oo610
Actively Recruiting
58
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
Catania, Sicily, Italy, 95122
Actively Recruiting
59
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Italy, 40123
Not Yet Recruiting
60
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
Milan, Italy, 20162
Not Yet Recruiting
61
Fondazione IRCCS San Gerardo Dei Tintori
Monza, Italy, 20900
Actively Recruiting
62
A.O.U. Maggiore della Carità
Novara, Italy, 28100
Actively Recruiting
63
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Italy, oo133
Not Yet Recruiting
64
AOU Citta della Salute e della Scienza di Torino
Torino, Italy, 10126
Not Yet Recruiting
65
Azienda sanitaria universitaria Giuliano Isontina
Trieste, Italy, 34129
Actively Recruiting
66
Azienda ULSS 8 Berica - Ospedale San Bortolo
Vicenza, Italy, 36100
Actively Recruiting
67
Chiba Aoba Municipal Hospital
Chuo-ku, Chiba, Japan, 260-0852
Actively Recruiting
68
Chibaken Saiseikai Narashino Hospital
Narashino-shi, Chiba, Japan, 275-8580
Actively Recruiting
69
National Hospital Organization Mito Medical Center
Ibaraki, Higashiibaraki-gun, Japan, 311-3193
Actively Recruiting
70
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024
Actively Recruiting
71
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
72
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan, 573-1191
Actively Recruiting
73
Hematology Ohta Clinic,Shinsaibashi
Osaka, Osaka, Japan, 542-0081
Actively Recruiting
74
Osaka University Hospital
Suita-shi, Osaka, Japan, 565-0871
Actively Recruiting
75
Saitama Medical University Hospital
Iruma-gun, Saitama, Japan, 350-0495
Actively Recruiting
76
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan, 113-8655
Actively Recruiting
77
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan, 173-8610
Actively Recruiting
78
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku, Tokyo, Japan, 130-0022
Actively Recruiting
79
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan, 400-8506
Actively Recruiting
80
Erasmus Medical Center, Department of Hematology
Rotterdam, South Holland, Netherlands, 3015 GD
Not Yet Recruiting
81
Hagaziekenhuis
The Hague, South Holland, Netherlands, 2545AA
Actively Recruiting
82
IN-VIVO sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-048
Withdrawn
83
Instytut Hematologii i Transfuzjologii Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych
Warsaw, Masovian Voivodeship, Poland, 02-776
Actively Recruiting
84
Pratia Onkologia Katowice - PRATIA
Katowice, Silesian Voivodeship, Poland, 40-523
Actively Recruiting
85
N. Copernicus Provincial MCOT in Lodz
Lodz, Łódź Voivodeship, Poland, 93-513
Actively Recruiting
86
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
87
Kyungpook National University Hospital
Daegu, South Korea, 41944
Actively Recruiting
88
Seoul National University Hospital (SNUH)
Seoul, South Korea, 03080
Actively Recruiting
89
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
90
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
91
Korea University Anam Hospital
Seoul, South Korea, 2841
Actively Recruiting
92
Asan Medical Center
Seoul, South Korea, 5505
Actively Recruiting
93
Hospital Universitario Fundacion Alcorcon
Alcorcón, Mardrid, Spain, 28922
Actively Recruiting
94
Hospital General Universitario Gregorio Maranon
Madrid, Mardrid, Spain, 28007
Actively Recruiting
95
Hospital Universitario 12 de Octubre
Madrid, Mardrid, Spain, 28041
Actively Recruiting
96
Hospital Universitario De Salaman
Salamanca, Spain, 37007
Actively Recruiting
97
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
98
Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology
Mamak, Ankara, Turkey (Türkiye), 6620
Not Yet Recruiting
99
Aydin Adnan Menderes University Medical Faculty-Hematology Department
Efeler, Aydın, Turkey (Türkiye), 9100
Not Yet Recruiting
100
Cerrahpasa Tip Fakultesi
Edirne, Turkey (Türkiye), 22030
Actively Recruiting
101
Trakya Universitesi Tip Fakultesi Hastanesi
Edirne, Turkey (Türkiye), 22030
Actively Recruiting
102
Sakarya University Education and Research Hospital
Sakarya, Turkey (Türkiye), 54290
Not Yet Recruiting
103
University Hospitals of Leicester NHS Trust
Leicester, East Midlands, United Kingdom, LE1 5WW
Actively Recruiting
104
Southampton General Hospital
Southampton, Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
105
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, Merseyside, United Kingdom, L7 8XP
Actively Recruiting
106
Greater Glasgow Health Board
Glasgow, Scotland, United Kingdom, G312ER
Actively Recruiting
107
University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Actively Recruiting
108
Leeds Teaching Hospitals NHS Trust
Leeds, Yorkshire, United Kingdom, LS9 TF
Actively Recruiting
109
Barts Health NHS Trust, Royal London Hospital
London, United Kingdom, E11BB
Actively Recruiting
110
University College London Hospitals
London, United Kingdom, NW1 2PG
Actively Recruiting
111
Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
112
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here