Immune Thrombocytopenic Purpura (ITP)Phase 3NCT06948318
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
A Phase 3 study testing Mezagitamab in people with Immune Thrombocytopenic Purpura (ITP), run by Takeda at 118 sites in 15 countries.
Trial 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 lower number of platelets, making it easier to bruise or bleed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenic Purpura (ITP)
- What is being tested?
- Mezagitamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 118 sitesin 15 countries
- Study dates
- 14 Aug 2025to 29 Jul 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. The participant has completed TAK-079-3002 (end of trial [EOT]) or TAK-079-1004 (EOT). Participants from TAK-079-1004 must have had a response to mezagitamab as demonstrated by meeting the criteria for "platelet response" specified for that trial during either the main study or open-label extension.
Who cannot join
- For TAK-079-3002 participants:
- 1. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.
- For TAK-079-1004 participants:
- The participant has had any thrombotic or embolic event within 12 months before signing the ICF.
- The participant has had a splenectomy within 3 months before signing the ICF.
- The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
Show all 18Show fewer
- History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for treated non-melanoma skin cancer or cervical carcinoma in situ.
- In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
- The participant has received anti-cluster of differentiation (CD) 20 treatment within 12 months before screening and either of the following applies:
- The last dose was received within 6 months before screening.
- The last dose was received between 6 and 12 months before screening and the participant has a CD19+ count below the lower limit of normal.
- The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Visit 1.
- The participant has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.
- The participant has used anticoagulants (for example, vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to Visit 1.
- 10 The participant has received a live or live-attenuated vaccine within 4 weeks prior to the first dose of trial treatment or has any live or live-attenuated vaccine planned during the trial.
- 11. The participant has used the following immunosuppressive agents as specified prior to Visit 1: alkylating agents (for example, cyclophosphamide) within 8 weeks, vinca alkaloids (for example, vincristine) within 4 weeks, sulfones (for example, dapsone) within 3 weeks, antiproliferative agents: (for example, mycophenolate mofetil and azathioprine) within 2 weeks, and calcineurin inhibitors: (for example, cyclosporine) within 2 weeks.
- 12. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.
- Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
118 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
118 sites in 15 countries
United States25 sites, 24 recruiting
- Not yet recruiting
Emory University
Atlanta, Georgia, 30308
Site Contact
Ana Antun
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Site Contact
David Kuter
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Site Contact
Bethany Samuelson Bannow
- Withdrawn
Rocky Mountain Cancer Center
Denver, Colorado, 80218
- Not yet recruiting
Duke University Hospital
Durham, North Carolina, 27710
Site Contact
Ara Metjian
- Not yet recruiting
East Carolina University
Greenville, North Carolina, 27837
Site Contact
Darla Liles
- Not yet recruiting
Genesis Cancer and Blood Institute - SCRI
Hot Springs, Arkansas, 71913
Site Contact
Lingyi Chen
- Not yet recruiting
Baylor College of Medicine
Houston, Texas, 77030
Site Contact
Senthil Sukumar
- Not yet recruiting
Innovative Hematology, Inc.
Indianapolis, Indiana, 46260
Site Contact
Sherwin Desouza
- Not yet recruiting
The University of Iowa
Iowa City, Iowa, 52242
Site Contact
Steven Lentz
- Not yet recruiting
MidAmerica Cancer Center
Kansas City, Missouri, 64132
Site Contact
Benjamin Fangman
- Not yet recruiting
USC Norris Comprehensive Cancer Center - Keck Medicine of USC
Los Angeles, California, 90033
Site Contact
Howard Liebman
- Not yet recruiting
University Of Louisville Brown Cancer Center
Louisville, Kentucky, 40202
Site Contact
Kamila Cisak
- Not yet recruiting
Versiti Wisconsin, Inc
Milwaukee, Wisconsin, 53226
Site Contact
Lisa Kreuziger
- Not yet recruiting
American Oncology Partners of Maryland, PA
Morristown, New Jersey, 07960
Site Contact
Ralph Boccia
- Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 28204
Site Contact
Avi Leader
- Not yet recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
Site Contact
Bremer Celeste
- Not yet recruiting
Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program
Philadelphia, Pennsylvania, 19104
Site Contact
Adam Cuker
- Not yet recruiting
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, 19140
Site Contact
Michael Bromberg
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Site Contact
Joseph Shatzel
- Not yet recruiting
University of California San Diego Center for Bleeding and Clotting Disorders
San Diego, California, 92121
Site Contact
Annette Von Drygalski
- Not yet recruiting
University of Washingto
Seattle, Washington, 98109
Site Contact
Sandhya Panch
- Not yet recruiting
Montefiore Medical Center
The Bronx, New York, 10461
Site Contact
Irina Murakhovskaya
- Not yet recruiting
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Site Contact
Catherine Broome
- Not yet recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
Site Contact
Daniel Winokur
China16 sites, 16 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Site Contact, +861069155027, zhutn@pumch.cn
Tienan Zhu
- Recruiting
West China Hospital Sichuan University
Chengdu, Sichuan, 610041
Site Contact, +862885422366, huaxigcp@163.com
Yuping Gong
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Site Contact, +8613437843806, lcw0589@163.com
Chengwei Luo
- Not yet recruiting
Zhejiang Provincial Hospital of Chinese Medicine - Main
Hangzhou, Zhejiang, 310006
Site Contact, +8613588453501, 13588453501@163.com
Baodong Ye
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Site Contact, +8653182169114-9879, houming@medmail.com.cn
Ming Hou
- Recruiting
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650101
Site Contact, +8618788571605, zhouzeping@kmmu.edu.cn
Zeping Zhou
- Recruiting
The First Affiliated Hospital of Nanchang University - Donghu Campus
Nanchang, Jiangxi, 330006
Site Contact, +867918692517, rbhuang69@163.com
Ruibin Huang
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Site Contact, +867715356566, jhlee3@amc.seoul.kr
Peng Cheng
- Recruiting
Jinshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 201508
Site Contact, +862164041990Ext.2718, ypark@augusta.edu
Yunfeng Cheng
- Not yet recruiting
Shengjing Hospital of China Medical University - Nanhu Campus
Shenyang, Liaoning, 110004
Site Contact, +8618940259833
Aijun Liao
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
Site Contact, +8631185917000, liuqingchi@sina.com
Qingchi Liu
- Not yet recruiting
The First Affiliated Hospital of Soochow University - Shizijie Campus
Suzhou, Jiangsu, 215006
Site Contact, +8613651003886, yinjie@suda.edu.cn
Jie Yin
- Recruiting
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
Tianjin, Tianjin Municipality, 300020
Site Contact, +8613502157159, chenyunfei@ihcams.ac.cn
Yunfei Chen
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hebei, 430022
Site Contact, +8613986183871, dr_huyu@126.com
Yu Hu
- Not yet recruiting
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068
Site Contact
Yi Wang
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450004
Site Contact, +8637165587320, tigerzhoupumc@163.com
Hu Zhou
Japan13 sites, 13 recruiting
- Recruiting
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8655
Site Contact, 03-3815-5411, kurokawa@m.u-tokyo.ac.jp
Mineo Kurokawa
- Not yet recruiting
Chiba Aoba Municipal Hospital
Chuo-ku, Chiba, 260-0852
Site Contact
Yokota Akira
- Recruiting
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191
Site Contact, tot@hirakata.kmu.ac.jp
Tomoki Ito
- Not yet recruiting
National Hospital Organization Mito Medical Center
Ibaraki, Higashiibaraki, 311-3193
Site Contact, 029-240-7711, Yoshida.chikashi.rc@mail.hosp.go.jp
Chikashi Yoshida
- Recruiting
Saitama Medical University Hospital
Iruma-gun, Saitama, 350-0495
Site Contact
Yoshitaka Miyakawa
- Recruiting
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, 173-8610
Site Contact, 03-3972-8111, ootake.shimon@nihon-u.ac.jp
Otake Shimon
- Recruiting
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, 400-8506
Site Contact, 055-253-7111
Masaki Iino
- Not yet recruiting
Chibaken Saiseikai Narashino Hospital
Narashino-shi, Chiba, 275-8580
Site Contact, 047-473-1281, choryuko@gmail.com
Ryuko Cho
- Recruiting
Hematology Ohta Clinic,Shinsaibashi
Osaka, Osaka, 542-0081
Site Contact, 81 6-6245-2117
Kensuke Ohta
- Recruiting
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Site Contact
Noriko Fukuhara
- Recruiting
Osaka University Hospital
Suita-shi, Osaka, 565-0871
Site Contact
Kato Hisashi
- Recruiting
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku, Tokyo, 130-0022
Site Contact
Kosugi Nobuharu
- Not yet recruiting
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024
Site Contact, 045-261-5656, takuya_m@yokohama-cu.ac.jp
Takuya Miyazaki
Italy11 sites, 11 recruiting
- Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, 40123
Site Contact
FRANCESCA PALANDRI
- Not yet recruiting
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
Catania, Sicily, 95122
Site Contact, +39 095 7595801, uconsoli@arnasgaribaldi.it
Ugo Consoli
- Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
Milan, 20162
Site Contact
Monica Carpenedo
- Not yet recruiting
Fondazione IRCCS San Gerardo Dei Tintori
Monza, 20900
Site Contact
Filippo Achille Brioschi
- Not yet recruiting
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, 80131
Site Contact, +39 081 7464289, fabrizio.pane@unina.it
Fabrizio Pane
- Recruiting
A.O.U. Maggiore della Carita
Novara, 28100
Site Contact, 39 0321 3733092, andrea.patriarca@uniupo.it
Andrea Patriarca
- Not yet recruiting
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
Rome, Lazio, oo610
Site Contact
Cristina Santoro
- Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, oo133
Site Contact
Francesco Buccisano
- Not yet recruiting
AOU Citta della Salute e della Scienza di Torino
Torino, 10126
Site Contact
Alessandra Borchiellini
- Recruiting
Azienda sanitaria universitaria Giuliano Isontina
Trieste, 34129
Site Contact
Elisa Lucchini
- Recruiting
Azienda ULSS 8 Berica - Ospedale San Bortolo
Vicenza, 36100
Site Contact, g.carli@aulss8.veneto.it
Giuseppe Carli
Australia10 sites, 10 recruiting
- Not yet recruiting
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Site Contact, +610297676348, vivien.chen@health.nsw.gov.au
Vivien Chen
- Recruiting
Canberra Hospital
Garran, Australian Capital Territory, 2605
Site Contact, +61251248492, phil.choi@act.gov.au
Philip Choi
- Recruiting
St George Hospital
Kogarah, New South Wales, 2217
Site Contact, +61 02 9113 3089, amanda.hugman@health.nsw.gov.au
Amanda Hugman
- Recruiting
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
Liverpool, New South Wales, 2170
Site Contact
Danny Hsu
- Not yet recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Site Contact
Isaac Goncalves
- Recruiting
Monash University - Australian Centre for Blood Diseases (ACBD)
Melbourne, Victoria, 3004
Site Contact
Zane Kaplan
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3005
Site Contact
Huyen Tran
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Site Contact
Dominic Pepperell
- Recruiting
Perth Blood Institute
West Perth, Western Australia, 6005
Site Contact, +61892005300, ross@pbi.org.au
Ross Baker
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Site Contact, +610288905200, Jennifer.curnow@health.nsw.gov.au
Jennifer Curnow
United Kingdom10 sites, 10 recruiting
- Not yet recruiting
Greater Glasgow Health Board
Glasgow, Scotland, G312ER
Site Contact
Bagot Catherine
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, Yorkshire, LS9 TF
Site Contact
Hill Quentin
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester, East Midlands, LE1 5WW
Site Contact, mamta.garg@uhl-tr.nhs.uk
Mamta Garg
- Not yet recruiting
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, Merseyside, L7 8XP
Site Contact
David Simcox
- Recruiting
Barts Health NHS Trust, Royal London Hospital
London, E11BB
Site Contact
Chen Frederick
- Not yet recruiting
University College London Hospitals
London, NW1 2PG
Site Contact, 442034479984, m.scully@nhs.net
Marie Ann Scully
- Recruiting
Imperial College Healthcare NHS Trust
London, W12 0HS
Site Contact
Nicola Cooper
- Recruiting
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
Site Contact, syed.kazmi@utsouthwestern.edu
Rashid Kazmi
- Not yet recruiting
Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust
Southwark, London, DE1 9RT
Site Contact
Vickie McDonald
- Recruiting
University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG
Site Contact
David Sutton
South Korea7 sites, 7 recruiting
- Not yet recruiting
Kyungpook National University Hospital
Daegu, 41944
Site Contact
Sang-Kyun Sohn
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Site Contact
Soo-Mee Bang
- Not yet recruiting
Seoul National University Hospital (SNUH)
Seoul, 03080
Site Contact
Youngil Koh
- Not yet recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Site Contact
June-Won Cheong
- Recruiting
Samsung Medical Center
Seoul, 06351
Site Contact
Jun Ho Jang
- Recruiting
Korea University Anam Hospital
Seoul, 2841
Site Contact
Yong Park
- Not yet recruiting
Asan Medical Center
Seoul, 5505
Site Contact
Je-Hwan Lee
Spain6 sites, 6 recruiting
- Not yet recruiting
Hospital Universitario Fundacion Alcorcon
Alcorcón, Mardrid, 28922
Site Contact
Francisco Javier Penalver Parraga
- Not yet recruiting
C.A.U de Burgos - Hospital Universitario de Burgos
Burgos, 9006
Site Contact
Tomas Jose Gonzalez-Lopez
- Not yet recruiting
Hospital General Universitario Gregorio Maranon
Madrid, Mardrid, 28007
Site Contact, +34 915868443 / +34 915868120, crisizquierdo3@yahoo.es
Cristina Pascual Izquierdo
- Not yet recruiting
Hospital Universitario 12 de Octubre
Madrid, Mardrid, 28041
Site Contact, +34 917792876, denis.zafra@salud.madrid.org
Denis Zafra Torres
- Not yet recruiting
Hospital Universitario De Salaman
Salamanca, 37007
Site Contact
Jose Ramon Gonzalez-Porras
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
Site Contact, +34 628377490, mariae.mingot.sspa@juntadeandalucia.es
Maria Eva Mingot Castellano
Bulgaria5 sites, 5 recruiting
- Recruiting
Medical Center "Fama Medical"
Plovdiv, 4002
Site Contact, +359887860806, kasapunarova@yahoo.com
Katya Sapunarova
- Recruiting
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, Sofia-Grad, 1606
Site Contact, (359) 884-6741 x60, viktoriia1982@abv.bg
Viktoria Barbukova
- Recruiting
UMHAT Sv. Ivan Rilski
Sofia, 1431
Site Contact
Atanas Radinoff
- Recruiting
UMHAT SofiaMed, OOD
Sofia, 1750
Site Contact, +359888627955, dr.alaikov@gmail.com
Tzvetan Alaykov
- Not yet recruiting
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, 6003
Site Contact
Mariya Todorova
Turkey (Türkiye)5 sites, 5 recruiting
- Not yet recruiting
Cerrahpasa Tip Fakultesi
Edirne, 22030
Site Contact
Cem Ar Muhlis
- Not yet recruiting
Trakya Universitesi Tip Fakultesi Hastanesi
Edirne, 22030
Site Contact, 905336000000, mdemir@trakya.edu.tr
Ahmet Muzaffer Demir
- Not yet recruiting
Aydin Adnan Menderes University Medical Faculty-Hematology Department
Efeler, Aydın, 9100
Site Contact, dryavas09@gmail.com
Irfan Yavasoglu
- Not yet recruiting
Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology
Mamak, Ankara, 6620
Site Contact, 905327000000, sktoprak@yahoo.com
Selami Toprak
- Not yet recruiting
Sakarya University Education and Research Hospital
Sakarya, 54290
Site Contact
Tuba Hacibekiroglu
Poland4 sites, 3 recruiting
- Withdrawn
IN-VIVO sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048
- Not yet recruiting
Pratia Onkologia Katowice - PRATIA
Katowice, Silesian Voivodeship, 40-523
Site Contact
Sebastian Grosicki
- Not yet recruiting
N. Copernicus Provincial MCOT in Lodz
Lodz, Łódź Voivodeship, 93-513
Site Contact
Jacek Trelinski
- Not yet recruiting
Instytut Hematologii i Transfuzjologii Klinika Zaburzen Hemostazy i Chorob Wewnetrznych
Warsaw, Masovian Voivodeship, 02-776
Site Contact
Jerzy Windyga
Greece2 sites, 2 recruiting
- Not yet recruiting
Olympion General Clinic & Rehabilitation Center
Pátrai, 264 43
Site Contact
Argiris Symeonidis
- Recruiting
General Hospital of Thessaloniki George Papanikolaou
Thessaloniki
Site Contact
Antonia Syrigou
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Erasmus Medical Center, Department of Hematology
Rotterdam, South Holland, 3015 GD
Site Contact
Arend Jan Gerard Jansen
- Not yet recruiting
Hagaziekenhuis
The Hague, South Holland, 2545AA
Site Contact
Tanja Netelenbos
Croatia1 site, 1 recruiting
- Not yet recruiting
Clinical Hospital Centar Zagreb
Zagreb, 10000
Site Contact
Drazen Pulanic
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong, Pok Fu Lam
Site Contact
Yok Lam Kwong
About this study
Official title: 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
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 lower number of platelets, making it easier to bruise or bleed. The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time.
Participants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met.
During the study, participants will visit their study clinic several times.
- Conditions
- Immune Thrombocytopenic Purpura (ITP)
- Being tested
- Mezagitamab
- Keywords
- TAK-079, Immune Thrombocytopenia, Chronic Primary Immune Thrombocytopenia, Blood Platelet Disorders, Hematologic Diseases, Cytopenia, Purpura, Hemorrhagic Disorders, Autoimmune Diseases, Immune System Diseases, Hemorrhage, Skin Manifestations, Purpura, Thrombocytopenic, Idiopathic, Purpura, Thrombocytopenic
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Blood Platelet Disorders, Hematologic Diseases, Cytopenia, Purpura, Hemorrhagic Disorders, Autoimmune Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MezagitamabDrug
Also called TAK-079
Mezagitamab injection administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Mezagitamab | Experimental | Eligible participants who completed the TAK-079-3002 or TAK-079-1004 studies can receive on-demand treatment in this continuation study. The on-demand treatment course may be repeated as needed based on the pre-specified on-demand dosing criteria and investigator's clinical judgement. Receives: Drug: Mezagitamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to mezagitamab in the parent trial for Cohort 1 and in this trial for Cohort 2. A serious TEAE is a TEAE that meets 1 or more of the criteria: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or was otherwise considered medically important.
Measured: Up to approximately 108 weeks
Number of Participants With TEAEs Leading to Permanent Withdrawal of Mezagitamab
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to mezagitamab in the parent trial for Cohort 1 and in this trial for Cohort 2.
Measured: Up to approximately 108 weeks
Secondary outcomes (10)
Duration of Platelet Response
The duration of platelet response will be measured by the cumulative number of weeks on which platelet count was ≥30,000/microliters (μL) and ≥50,000/μL throughout the trial.
Measured: Up to approximately 108 weeks
Duration Between On-Demand Treatment Courses
Measured: Up to approximately 108 weeks
Time to Initiation of the First On-Demand Treatment Course
Measured: Up to approximately 108 weeks
Number of Participants With Complete Response
Complete response is defined as achieving platelet counts ≥100,000/μL on at least 2 visits.
Measured: Up to approximately 108 weeks
Number of Participants With Immune Thrombocytopenia (ITP) Remission
ITP Remission is defined as all platelet counts ≥50,000/μL for at least 24 weeks after any mezagitamab treatment cycle in the absence of further therapy for ITP.
Measured: Up to approximately 108 weeks
Number of Participants With Reduction in Dose and/or Frequency of Concomitant ITP Medications
Concomitant ITP medications are defined as those given in addition to the trial intervention to treat your ITP. These medications include corticosteroids, thrombopoietin receptor agonists (TPO-RA), or fostamatinib.
Measured: Up to approximately 108 weeks
Number of Participants Requiring Rescue Therapy
Measured: Up to approximately 108 weeks
Serum Concentrations of Mezagitamab
Measured: Pre-dose and at multiple time points post-dose up to Week 104
Number of Participants With Anti-Drug Antibodies (ADA)
Measured: Pre-dose and at multiple time points post-dose up to Week 104
Number of Participants With Neutralizing Antibody (NAb)
Measured: Pre-dose and at multiple time points post-dose up to Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start14 Aug 2025
- Primary completion29 Jul 2029 (estimated)
- Study completion29 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenic Purpura (ITP)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948318
- Sponsor's protocol ID
- TAK-079-3003
- Other IDs
- 2025-521692-31-00, jRCT2031250237, 2025
- Status last verified
- Sep 2026
- First submitted
- 25 Apr 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.