Actively Recruiting
A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults With Chronic Primary Immune Thrombocytopenia
Led by Takeda · Updated on 2026-06-05
150
Participants Needed
108
Research Sites
N/A
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, leading to a lower platelet count and increased risk of bruising or bleeding. This research aims to evaluate the long-term safety, tolerability, effectiveness, and how the body processes mezagitamab in adults with chronic primary ITP. Participants who previously took part in related mezagitamab studies (TAK-079-3002 and TAK-079-1004) are invited to join this continuation study. Eligible participants will receive mezagitamab injections under pre-specified criteria and as needed, based on their clinical condition and the investigator's judgment. This on-demand treatment may be repeated multiple times during the study. The study is an open-label, phase 3 trial that monitors participants over an extended period with repeated dosing as required. Participants will visit the study clinic multiple times for assessments throughout the study, which may last up to approximately 108 weeks. Researchers will monitor treatment-emergent adverse events, platelet response duration, use of other ITP medications, and the presence of antibodies against the drug. Blood samples will be collected to measure drug levels and immune responses. Safety and effectiveness will be closely followed, including any need for rescue therapies.
CONDITIONS
Brief Title
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have completed the TAK-079-3002 or TAK-079-1004 mezagitamab studies
- Participants from TAK-079-1004 must have shown a platelet response to mezagitamab during the prior study or its extension
- Adults aged 18 years or older
You will not qualify if you...
- History of severe allergic or anaphylactic reactions to mezagitamab or its ingredients (for TAK-079-3002 participants)
- History of blood clots or embolic events within 12 months before consent (for TAK-079-1004 participants)
- Splenectomy within 3 months before consent (for TAK-079-1004 participants)
- Active infection with hepatitis B, hepatitis C, or HIV (for TAK-079-1004 participants)
- History of malignancy within 5 years except treated non-melanoma skin cancer or cervical carcinoma in situ (for TAK-079-1004 participants)
- Serious medical or psychiatric illness that might interfere with treatment completion
- Anti-CD20 treatment within 12 months before screening with specific timing and immune cell count restrictions
- Use of monoclonal or polyclonal antibodies for immunomodulation within 6 months before Visit 1
- Exposure to other investigational agents within 4 weeks or 5 half-lives before Visit 1
- Use of anticoagulants within 3 weeks prior to Visit 1
- Use or planned use of live or live-attenuated vaccines within 4 weeks before or during the trial
- Use of specified immunosuppressive agents within defined periods before Visit 1
- History of severe allergic or anaphylactic reactions to mezagitamab or its ingredients (for TAK-079-1004 participants)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 108 weeks
Participants receive on-demand mezagitamab injections as needed based on dosing criteria and clinical judgement.
Visits occur on-demand corresponding with treatment courses and assessments up to Week 108
Trial Site Locations
Total: 108 locations
1
USC Norris Comprehensive Cancer Center - Keck Medicine of USC
Los Angeles, California, United States, 90033
Not Yet 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
Not Yet Recruiting
4
Emory University
Atlanta, Georgia, United States, 30308
Not Yet Recruiting
5
The University of Iowa
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
6
University Of Louisville Brown Cancer Center
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
Not Yet Recruiting
9
Duke University Hospital
Durham, North Carolina, United States, 27710
Not Yet Recruiting
10
East Carolina University
Greenville, North Carolina, United States, 27837
Not Yet Recruiting
11
Oregon Health & Science University
Portland, Oregon, United States, 97239
Not Yet Recruiting
12
Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
13
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, United States, 19140
Not Yet Recruiting
14
Baylor College of Medicine
Houston, Texas, United States, 77030
Not Yet Recruiting
15
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Not Yet Recruiting
16
University of Washingto
Seattle, Washington, United States, 98109
Not Yet Recruiting
17
Versiti Wisconsin, Inc
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
18
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Actively Recruiting
19
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Not Yet Recruiting
20
St George Hospital
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
21
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
22
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
23
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Not Yet Recruiting
24
Monash University - Australian Centre for Blood Diseases (ACBD)
Melbourne, Victoria, Australia, 3004
Actively Recruiting
25
The Alfred Hospital
Melbourne, Victoria, Australia, 3005
Actively Recruiting
26
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Not Yet Recruiting
27
Perth Blood Institute
West Perth, Western Australia, Australia, 6005
Actively Recruiting
28
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, Sofia-Grad, Bulgaria, 1606
Actively Recruiting
29
Medical Center "Fama Medical"
Plovdiv, Bulgaria, 4002
Not Yet Recruiting
30
UMHAT Sv. Ivan Rilski
Sofia, Bulgaria, 1431
Actively Recruiting
31
UMHAT SofiaMed, OOD
Sofia, Bulgaria, 1750
Not Yet Recruiting
32
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, Bulgaria, 6003
Not Yet Recruiting
33
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
34
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Not Yet Recruiting
35
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
36
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050031
Actively Recruiting
37
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hebei, China, 430022
Actively Recruiting
38
Henan Cancer Hospital
Zhengzhou, Henan, China, 450004
Actively Recruiting
39
The First Affiliated Hospital of Soochow University - Shizijie Campus
Suzhou, Jiangsu, China, 215006
Not Yet Recruiting
40
The First Affiliated Hospital of Nanchang University - Donghu Campus
Nanchang, Jiangxi, China, 330006
Actively Recruiting
41
Shengjing Hospital of China Medical University - Nanhu Campus
Shenyang, Liaoning, China, 110004
Not Yet Recruiting
42
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China, 710068
Not Yet Recruiting
43
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
44
Jinshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201508
Actively Recruiting
45
West China Hospital Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
46
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
47
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650101
Actively Recruiting
48
Zhejiang Provincial Hospital of Chinese Medicine - Main
Hangzhou, Zhejiang, China, 310006
Not Yet Recruiting
49
Clinical Hospital Centar Zagreb
Zagreb, Croatia, 10000
Not Yet Recruiting
50
Queen Mary Hospital
Hong Kong, Pok Fu Lam, Hong Kong
Actively Recruiting
51
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, Italy, 80131
Not Yet Recruiting
52
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
Rome, Lazio, Italy, oo610
Not Yet Recruiting
53
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
Catania, Sicily, Italy, 95122
Not Yet Recruiting
54
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Italy, 40123
Not Yet Recruiting
55
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
Milan, Italy, 20162
Not Yet Recruiting
56
Fondazione IRCCS San Gerardo Dei Tintori
Monza, Italy, 20900
Not Yet Recruiting
57
A.O.U. Maggiore della Carita
Novara, Italy, 28100
Actively Recruiting
58
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Italy, oo133
Not Yet Recruiting
59
AOU Citta della Salute e della Scienza di Torino
Torino, Italy, 10126
Not Yet Recruiting
60
Azienda sanitaria universitaria Giuliano Isontina
Trieste, Italy, 34129
Actively Recruiting
61
Azienda ULSS 8 Berica - Ospedale San Bortolo
Vicenza, Italy, 36100
Not Yet Recruiting
62
Chiba Aoba Municipal Hospital
Chuo-ku, Chiba, Japan, 260-0852
Not Yet Recruiting
63
Chibaken Saiseikai Narashino Hospital
Narashino-shi, Chiba, Japan, 275-8580
Not Yet Recruiting
64
National Hospital Organization Mito Medical Center
Ibaraki, Higashiibaraki, Japan, 311-3193
Not Yet Recruiting
65
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024
Not Yet Recruiting
66
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
67
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan, 573-1191
Not Yet Recruiting
68
Hematology Ohta Clinic,Shinsaibashi
Osaka, Osaka, Japan, 542-0081
Actively Recruiting
69
Osaka University Hospital
Suita-shi, Osaka, Japan, 565-0871
Actively Recruiting
70
Saitama Medical University Hospital
Iruma-gun, Saitama, Japan, 350-0495
Actively Recruiting
71
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan, 113-8655
Actively Recruiting
72
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan, 173-8610
Actively Recruiting
73
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku, Tokyo, Japan, 130-0022
Actively Recruiting
74
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan, 400-8506
Actively Recruiting
75
Erasmus Medical Center, Department of Hematology
Rotterdam, South Holland, Netherlands, 3015 GD
Not Yet Recruiting
76
Hagaziekenhuis
The Hague, South Holland, Netherlands, 2545AA
Not Yet Recruiting
77
IN-VIVO sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-048
Withdrawn
78
Instytut Hematologii i Transfuzjologii Klinika Zaburzen Hemostazy i Chorob Wewnetrznych
Warsaw, Masovian Voivodeship, Poland, 02-776
Not Yet Recruiting
79
Pratia Onkologia Katowice - PRATIA
Katowice, Silesian Voivodeship, Poland, 40-523
Not Yet Recruiting
80
N. Copernicus Provincial MCOT in Lodz
Lodz, Łódź Voivodeship, Poland, 93-513
Not Yet Recruiting
81
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
82
Kyungpook National University Hospital
Daegu, South Korea, 41944
Not Yet Recruiting
83
Seoul National University Hospital (SNUH)
Seoul, South Korea, 03080
Not Yet Recruiting
84
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Not Yet Recruiting
85
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
86
Korea University Anam Hospital
Seoul, South Korea, 2841
Actively Recruiting
87
Asan Medical Center
Seoul, South Korea, 5505
Not Yet Recruiting
88
Hospital Universitario Fundacion Alcorcon
Alcorcón, Mardrid, Spain, 28922
Not Yet Recruiting
89
Hospital General Universitario Gregorio Maranon
Madrid, Mardrid, Spain, 28007
Not Yet Recruiting
90
Hospital Universitario 12 de Octubre
Madrid, Mardrid, Spain, 28041
Not Yet Recruiting
91
C.A.U de Burgos - Hospital Universitario de Burgos
Burgos, Spain, 9006
Not Yet Recruiting
92
Hospital Universitario De Salaman
Salamanca, Spain, 37007
Not Yet Recruiting
93
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
94
Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology
Mamak, Ankara, Turkey (Türkiye), 6620
Not Yet Recruiting
95
Aydin Adnan Menderes University Medical Faculty-Hematology Department
Efeler, Aydın, Turkey (Türkiye), 9100
Not Yet Recruiting
96
Cerrahpasa Tip Fakultesi
Edirne, Turkey (Türkiye), 22030
Not Yet Recruiting
97
Trakya Universitesi Tip Fakultesi Hastanesi
Edirne, Turkey (Türkiye), 22030
Not Yet Recruiting
98
Sakarya University Education and Research Hospital
Sakarya, Turkey (Türkiye), 54290
Not Yet Recruiting
99
University Hospitals of Leicester NHS Trust
Leicester, East Midlands, United Kingdom, LE1 5WW
Actively Recruiting
100
Southampton General Hospital
Southampton, Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
101
Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust
Southwark, London, United Kingdom, DE1 9RT
Not Yet Recruiting
102
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, Merseyside, United Kingdom, L7 8XP
Not Yet Recruiting
103
Greater Glasgow Health Board
Glasgow, Scotland, United Kingdom, G312ER
Not Yet Recruiting
104
University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Not Yet Recruiting
105
Leeds Teaching Hospitals NHS Trust
Leeds, Yorkshire, United Kingdom, LS9 TF
Actively Recruiting
106
Barts Health NHS Trust, Royal London Hospital
London, United Kingdom, E11BB
Actively Recruiting
107
University College London Hospitals
London, United Kingdom, NW1 2PG
Not Yet Recruiting
108
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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