Immune Thrombocytopenic Purpura (ITP)Phase 3NCT06722235
A 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 124 sites in 18 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 low 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?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 124 sitesin 18 countries
- Study dates
- 27 Feb 2025to 16 Mar 2028
- 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
- The participant has been diagnosed with ITP that has persisted for at least 12 months.
- The participant's diagnosis of ITP is supported by a prior response to an ITP therapy (not including a thrombopoietin receptor agonist [TPO-RA]), defined as having achieved a platelet count ≥50,000/μL.
- The participant has evidence of insufficient response or intolerance to at least 1 currently available first-line therapy for treatment of ITP (for example, corticosteroids), and at least 1 currently available second-line therapy for treatment of ITP (for example, TPO-RA, rituximab, fostamatinib, mycophenolate). Insufficient response to previous treatment is defined as failure to achieve a sustained platelet count of at least 50,000/μL or doubling of baseline platelet count after an appropriate course of prior ITP treatment. Intolerance is defined as a documented side effect causing discontinuation of the therapy.
- The participant has a mean platelet count of less than (<)30,000/μL.
- If the participant is receiving allowed standard-of-care treatment for ITP at screening, and continued use is intended, treatment may continue during the trial if the dose, and frequency have been stable for at least 4 weeks before receiving the first dose of IMP (i.e., Day 1), and are expected to remain stable throughout the trial.
- If the participant is an individual with potential for pregnancy, the participant is not pregnant as confirmed by negative human chorionic gonadotropin during screening, and before the first dose of trial intervention.
Who cannot join
- The participant has secondary ITP.
- The participant has had any thrombotic or embolic event within 12 months before signing the informed consent form (ICF).
- The participant has had a splenectomy.
- The participant has active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
- 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.
Show all 17Show fewer
- 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 cluster of differentiation 19 positive (CD19+) count below the lower limit of normal.
- The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before screening.
- The participant has any prior exposure to mezagitamab or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Day 1.
- The participant has used anticoagulants (e.g., vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to the first dose of trial treatment.
- 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.
- The participant has used the following immunosuppressive agents as specified prior to the first dose of trial treatment: alkylating agents (e.g., cyclophosphamide) within 8 weeks, vinca alkaloids (e.g., vincristine) within 4 weeks, sulfones (e.g., dapsone) within 3 weeks, antiproliferative agents: (e.g., mycophenolate mofetil, and azathioprine) within 2 weeks, and calcineurin inhibitors: (e.g., cyclosporine) within 2 weeks.
- The participant has used intravenous immunoglobulin (IVIg), SC immunoglobulin, recombinant human thrombopoietin, anti-D immunoglobulin treatment, or efgartigimod within 4 weeks before signing the ICF or it is expected that any treatment for thrombocytopenia other than the participant's standard-of-care ITP therapy (e.g., rescue therapy, administration of blood products) may be used between screening, and Day 1.
- The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab/placebo formulation.
- Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
124 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
124 sites in 18 countries
United States25 sites, 23 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30308
Site Contact
Ana Antun
- Recruiting
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
Site Contact, 301-571-2016, Taylor.Stutzman@aoncology.com
Ralph Boccia
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Site Contact, 617-726-8743, dkuter@mgh.harvard.edu
David Kuter
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Site Contact
Bethany Samuelson Bannow
- Withdrawn
Rocky Mountain Cancer Center
Denver, Colorado, 80218
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Site Contact, 919-681-2668, Kristin.byrne@duke.edu
Ara Metjian
- Recruiting
East Carolina University
Greenville, North Carolina, 27837
Site Contact, 252-744-3617, Wootenk16@ecu.edu
Darla Liles
- Recruiting
Genesis Cancer and Blood Institute - SCRI
Hot Springs, Arkansas, 71913
Site Contact
Lingyi Chen
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Site Contact, senthil.sukumar@bcm.edu
Senthil Sukumar
- Not yet recruiting
Innovative Hematology, Inc.
Indianapolis, Indiana, 46260
Site Contact
Sherwin Desouza
- Recruiting
The University of Iowa
Iowa City, Iowa, 52242
Site Contact, 319-384-9643, darby-donovan@uiowa.edu
Steven Lentz
- Recruiting
MidAmerica Cancer Center
Kansas City, Missouri, 64132
Site Contact
Benjamin Fangman
- Recruiting
USC Norris Comprehensive Cancer Center - Keck Medicine of USC
Los Angeles, California, 90033
Site Contact, duran_c@med.usc.edu
Howard Liebman
- Recruiting
University Of Louisville Brown Cancer Center
Louisville, Kentucky, 40202
Site Contact, 502-562-3429, t0trox01@louisville.edu
Kamila Cisak
- Recruiting
Versiti Wisconsin, Inc
Milwaukee, Wisconsin, 53226
Site Contact
Lisa Kreuziger
- Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 28204
Site Contact
Avi Leader
- Recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
Site Contact, 404-778-7062, ana.antun@emoryhealthcare.org
Celeste Bremer
- Recruiting
Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program
Philadelphia, Pennsylvania, 19104
Site Contact, 862-372-8544, emmanuel.ndukwudimma@pennmedicine.upenn.edu
Adam Cuker
- Recruiting
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, 19140
Site Contact, 215-707-3453, michael.bromberg@tuhs.temple.edu
Michael Bromberg
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Site Contact, 503-949-1080, trials@ohsu.edu
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
- Recruiting
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Site Contact, 202-687-3044, js4936@georgetown.edu
Catherine Broome
- Completed
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
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
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Site Contact, +8613437843806, lcw0589@163.com
Chengwei Luo
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, 40123
Site Contact, palandri.francesca2@gmail.com
FRANCESCA PALANDRI
- 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
- Recruiting
Fondazione IRCCS San Gerardo Dei Tintori
Monza, 20900
Site Contact, filippoachille.brioschi@irccs-sangerardo.it
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
- 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
- Recruiting
AOU Citta della Salute e della Scienza di Torino
Torino, 10126
Site Contact, aborchiellini@cittadellasalute.to.it
Alessandra Borchiellini
- Recruiting
Azienda sanitaria universitaria Giuliano Isontina
Trieste, 34129
Site Contact, elisa.lucchini@asugi.sanita.fvg.it
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
- 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, +610291131111, silvia.zheng@health.nsw.gov.au
Silvia Zheng
- 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
- Recruiting
Greater Glasgow Health Board
Glasgow, Scotland, G312ER
Site Contact
Bagot Catherine
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, Yorkshire, LS9 TF
Site Contact, 113 206 8577, leedsth-tr.Haematology-Clinical-Trials@nhs.net
Quentin Hill
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester, East Midlands, LE1 5WW
Site Contact, mamta.garg@uhl-tr.nhs.uk
Mamta Garg
- Recruiting
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, Merseyside, L7 8XP
Site Contact, 1517063397, Haematology.Research@liverpoolft.nhs.uk
David Simcox
- Recruiting
Barts Health NHS Trust, Royal London Hospital
London, E11BB
Site Contact
Chen Frederick
- 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
Rashid Kazmi
- Recruiting
Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust
Southwark, London, SE1 9RT
Site Contact, 44 (0) 20-3594-1869, vickiemcdonald@nhs.net
Vickie McDonald
- Recruiting
University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG
Site Contact, 01782 674283, david.sutton@uhnm.nhs.uk
David Sutton
South Korea7 sites, 7 recruiting
- 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
- Recruiting
Seoul National University Hospital (SNUH)
Seoul, 03080
Site Contact
Youngil Koh
- 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
- Recruiting
Asan Medical Center
Seoul, 5505
Site Contact
Je-Hwan Lee
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, 359884933151, aradinoff@hotmail.com
Atanas Radinoff
- Recruiting
UMHAT SofiaMed, OOD
Sofia, 1750
Site Contact, +359888627955, dr.alaikov@gmail.com
Tzvetan Alaykov
- Recruiting
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, 6003
Site Contact, 359884303483, dr.maria.dtodorova@gmail.com
Mariya Todorova
Spain5 sites, 5 recruiting
- Recruiting
Hospital Universitario Fundacion Alcorcon
Alcorcón, Mardrid, 28922
Site Contact, 34916219524, franciscojavier.penalver@salud.madrid.org
Francisco Javier Penalver Parraga
- Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, Mardrid, 28007
Site Contact, +34 915868443 / +34 915868120, crisizquierdo3@yahoo.es
Cristina Pascual Izquierdo
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Mardrid, 28041
Site Contact, +34 917792876, denis.zafra@salud.madrid.org
Denis Zafra Torres
- Recruiting
Hospital Universitario De Salaman
Salamanca, 37007
Site Contact, 923291100, Jrgporras@saludcastillayleon.es
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
Turkey (Türkiye)5 sites, 5 recruiting
- Recruiting
Cerrahpasa Tip Fakultesi
Edirne, 22030
Site Contact, 905326818890, mcemar68@yahoo.com
Muhlis Cem Ar
- Recruiting
Trakya Universitesi Tip Fakultesi Hastanesi
Edirne, 22030
Site Contact, 905336000000, mdemir@trakya.edu.tr
Ahmet Muzaffer Demir
- Recruiting
Aydin Adnan Menderes University Medical Faculty-Hematology Department
Efeler, Aydın, 9100
Site Contact, dryavas09@gmail.com
Irfan Yavasoglu
- 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, 905054785579, hacibekiroglu@sakarya.edu.tr
Tuba Hacibekiroglu
Poland4 sites, 3 recruiting
- Withdrawn
IN-VIVO sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048
- Recruiting
Pratia Onkologia Katowice - PRATIA
Katowice, Silesian Voivodeship, 40-523
Site Contact, 501 714 019, kontakt.onkologia.katowice@pratia.com
Sebastian Grosicki
- Recruiting
N. Copernicus Provincial MCOT in Lodz
Lodz, Łódź Voivodeship, 93-513
Site Contact, 607 072 330, jacek.trelinski@umed.lodz.pl
Jacek Trelinski
- Recruiting
Instytut Hematologii i Transfuzjologii Klinika Zaburzen Hemostazy i Chorob Wewnetrznych
Warsaw, Masovian Voivodeship, 02-776
Site Contact, 22 34 96 158, jwindyga@ihit.waw.pl
Jerzy Windyga
Norway3 sites, 3 recruiting
- Recruiting
Universitetet i Bergen
Bergen, 5021
Site Contact, 47 55-97-50-00, galina.tsykunova@helse-bergen.no
Galina Tsykunova
- Not yet recruiting
Sykehuset Ostfold
Grålum, 1714
Site Contact
Waleed Ghanima
- Not yet recruiting
Akershus Universitetssykehus
Lorenskog, 1478
Site Contact
Hoa Tran
France2 sites, 2 recruiting
- Not yet recruiting
Hospital Henri Mondor
Créteil, 94000
Site Contact
Marc Michel
- Not yet recruiting
Chu Dijon - Bourgogne
Dijon, Bourgogne-Franche-Comté, 1000
Site Contact
Bernard Bonnotte
Greece2 sites, 2 recruiting
- Recruiting
Olympion General Clinic & Rehabilitation Center
Pátrai, 264 43
Site Contact, 306944960012, argiris.symeonidis@yahoo.gr
Argiris Symeonidis
- Recruiting
General Hospital of Thessaloniki George Papanikolaou
Thessaloniki, 570 10
Site Contact, +30 6944226001, antonia.syrigou@gmail.com
Antonia Syrigou
Netherlands2 sites, 2 recruiting
- Recruiting
Erasmus Medical Center, Department of Hematology
Rotterdam, South Holland, 3015 GD
Site Contact, a.j.g.jansen@erasmusmc.nl
Arend Jan Gerard Jansen
- Recruiting
Hagaziekenhuis
The Hague, South Holland, 2545AA
Site Contact
Tanja Netelenbos
Sweden2 sites, 2 recruiting
- Recruiting
Karolinska Universitetssjukhuset
Huddinge, Stockholm County, 14186
Site Contact, 46812387651, cecilia.karlstrom@regionstockholm.se
Cecilia Karlstrom
- Not yet recruiting
Skanes University hospital, Hematology Department
Malmö, 205 02
Site Contact
Alexandros Arvanitakis
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, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants 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 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.
Read more
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
- Immune Thrombocytopenic Purpura (ITP)
- Being tested
- Mezagitamab, Placebo
- Keywords
- Thrombocytopenia, TAK-079, 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, Thrombocytopenia, Blood Platelet Disorders, Hematologic Diseases, Cytopenia, Purpura, Hemorrhagic Disorders, Autoimmune 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.
PlaceboDrug
Mezagitamab-matching placebo injection administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Mezagitamab | Experimental | Participants will receive mezagitamab injection, SC, once weekly (QW). They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses. Receives: Drug: Mezagitamab |
| Placebo | Placebo comparator | Participants will receive mezagitamab-matching placebo injection, SC, QW. They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Durable Platelet Response
Durable platelet response is defined as platelet count greater than or equal to (≥)50,000/microliter (μL) on at least 4 of the 6 weekly platelet measurements between Weeks 19 and 24.
Measured: Up to Week 24
Secondary outcomes (13)
Cumulative Number of Weeks With a Platelet Count of ≥50,000/μL
The cumulative number of weeks in which the platelet count is ≥50,000/μL through Week 24.
Measured: Up to Week 24
Time to First Platelet Count ≥50,000/μL
Measured: Up to Week 24
Cumulative Number of Weeks With a Platelet Count of ≥30,000/μL
The cumulative number of weeks in which the platelet count is ≥30,000/μL, and at least doubled from baseline through Week 24.
Measured: Up to Week 24
Percentage of Participants With Complete Platelet Response
Complete platelet response is defined as a platelet count ≥100,000/μL on at least 2 visits through Week 24.
Measured: Up to Week 24
Percentage of Participants With Platelet Response at Week 16
Platelet response is defined as a platelet count ≥50,000/μL before investigational medicinal product (IMP) administration at the Week 16 visit.
Measured: Week 16
Change from Baseline in the Symptoms Domain Score of the Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) at Weeks 16 and 24
ITP-PAQ is a 44-item participant reported outcome (PRO) measure that assesses disease-specific health-related quality of life (HRQoL) that includes 10 domains: Symptoms, Fatigue/Sleep, Physical Health - Bother, Physical Health - Activity, Emotional Health - Psychological, Emotional Health - Fear, Overall Quality of Life (QoL), Social Activity, Women's Reproductive Health (including Fertility subscale, and Menstrual Symptoms subscale), and Work. The 6-item symptoms domain is scored from 0 to 100, with a positive change from baseline representing improvement of symptoms.
Measured: Weeks 16 and 24
Change from Baseline in Physical Fatigue (Item 10) Score of the ITP-PAQ at Weeks 16 and 24
ITP-PAQ is a 44-item participant reported outcome (PRO) measure that assesses disease-specific health-related quality of life (HRQoL) that includes 10 domains: Symptoms, Fatigue/Sleep, Physical Health - Bother, Physical Health - Activity, Emotional Health - Psychological, Emotional Health - Fear, Overall Quality of Life (QoL), Social Activity, Women's Reproductive Health (including Fertility subscale, and Menstrual Symptoms subscale), and Work. Physical fatigue is scored from 0 to 100, with a positive change from baseline representing improvement in physical fatigue.
Measured: Weeks 16 and 24
Percentage of Participants Receiving Rescue Therapy
Measured: Up to Week 24
Percentage of Participants With Bleeding Events
Bleeding events are defined as Grade ≥2 in the skin domain, or Grade ≥1 in the mucosal domain, or Grade ≥1 in the organ domain, in the immune thrombocytopenia-specific bleeding assessment tool (ITP-BAT) through Week 24.
Measured: Up to Week 24
Serum Concentration of Mezagitamab During and After Intervention
Measured: Predose on Day 1 and at multiple time points post-dose up to Day 169
Number of Participants With Anti-drug Antibodies (ADA)
Measured: Predose on Day 1 and at multiple time points post-dose up to Day 169
Change in ADA Titers Over Time
Measured: Up to Day 169
Number of Participants With Neutralizing ADA
Measured: Predose on Day 1 and at multiple time points post-dose up to Day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start27 Feb 2025
- Primary completion16 Mar 2028 (estimated)
- Study completion16 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 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
- NCT06722235
- Sponsor's protocol ID
- TAK-079-3002
- Other IDs
- 2024-514401-54-00, jRCT2031240667
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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.
Publications
Mayer KA, Budde K, Diebold M, Halloran PF, Bohmig GA. Targeting CD38 in Antibody-Mediated Rejection. Transpl Int. 2025 May 15;38:14343. doi: 10.3389/ti.2025.14343. eCollection 2025.
PubMed 40444214