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AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.
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  • 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.

Takeda Contact contact

+1-877-825-3327

medinfoUS@takeda.com

124 sites in 18 countries

United States25 sites, 23 recruiting

  • Emory University

    Atlanta, Georgia, 30308

    Site Contact, 404-778-7062, ana.antun@emoryhealthcare.org

    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

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Site Contact

    Bethany Samuelson Bannow

    Not yet recruiting

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

    Withdrawn

  • 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

    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

    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

    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

    Recruiting

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

    Completed

Other trials in United States

China16 sites, 13 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

    Completed

  • Zhejiang Provincial Hospital of Chinese Medicine - Main

    Hangzhou, Zhejiang, 310006

    Completed

  • 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

    Completed

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450004

    Site Contact, +8637165587320, tigerzhoupumc@163.com

    Hu Zhou

    Recruiting

Other trials in China

Japan13 sites, 13 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

  • 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

  • Nihon University Itabashi Hospital

    tabashi City, Tokyo, 173-8610

    Site Contact, 03-3972-8111, ootake.shimon@nihon-u.ac.jp

    Otake Shimon

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

    Site Contact, 045-261-5656, takuya_m@yokohama-cu.ac.jp

    Takuya Miyazaki

    Recruiting

Other trials in Japan

Italy11 sites, 3 recruiting

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, 40123

    Active, not recruiting

  • Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

    Catania, Sicily, 95122

    Active, not 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

    Active, not recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Campania, 80131

    Site Contact, +39 081 7464289, fabrizio.pane@unina.it

    Fabrizio Pane

    Not yet recruiting

  • A.O.U. Maggiore della Carita

    Novara, 28100

    Active, not recruiting

  • Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma

    Rome, Lazio, oo610

    Active, not 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

    Active, not recruiting

  • Azienda sanitaria universitaria Giuliano Isontina

    Trieste, 34129

    Active, not recruiting

  • Azienda ULSS 8 Berica - Ospedale San Bortolo

    Vicenza, 36100

    Active, not recruiting

Other trials in Italy

Australia10 sites, 10 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

    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

    Recruiting

Other trials in Australia

United Kingdom10 sites

  • Greater Glasgow Health Board

    Glasgow, Scotland, G312ER

    Active, not recruiting

  • Leeds Teaching Hospitals NHS Trust

    Leeds, Yorkshire, LS9 TF

    Active, not recruiting

  • University Hospitals of Leicester NHS Trust

    Leicester, East Midlands, LE1 5WW

    Active, not recruiting

  • Royal Liverpool and Broadgreen University Hospitals NHS Trust

    Liverpool, Merseyside, L7 8XP

    Active, not recruiting

  • Barts Health NHS Trust, Royal London Hospital

    London, E11BB

    Active, not recruiting

  • University College London Hospitals

    London, NW1 2PG

    Active, not recruiting

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

    Active, not recruiting

  • Southampton General Hospital

    Southampton, Hampshire, SO16 6YD

    Active, not recruiting

  • Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust

    Southwark, London, SE1 9RT

    Active, not recruiting

  • University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital

    Stoke-on-Trent, Staffordshire, ST4 6QG

    Active, not recruiting

Other trials in United Kingdom

South Korea7 sites, 7 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

    Recruiting

Other trials in South Korea

Bulgaria5 sites

  • Medical Center "Fama Medical"

    Plovdiv, 4002

    Active, not recruiting

  • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

    Sofia, Sofia-Grad, 1606

    Active, not recruiting

  • UMHAT Sv. Ivan Rilski

    Sofia, 1431

    Active, not recruiting

  • UMHAT SofiaMed, OOD

    Sofia, 1750

    Active, not recruiting

  • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD

    Stara Zagora, 6003

    Active, not recruiting

Other trials in Bulgaria

Spain5 sites

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, Mardrid, 28922

    Active, not recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Mardrid, 28041

    Active, not recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

    Active, not recruiting

  • Hospital Universitario De Salaman

    Salamanca, 37007

    Active, not recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Active, not recruiting

Other trials in Spain

Turkey (Türkiye)5 sites, 5 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

    Recruiting

  • Sakarya University Education and Research Hospital

    Sakarya, 54290

    Site Contact, 905054785579, hacibekiroglu@sakarya.edu.tr

    Tuba Hacibekiroglu

    Not yet recruiting

Other trials in Turkey (Türkiye)

Poland4 sites

  • IN-VIVO sp. z o.o.

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048

    Withdrawn

  • Pratia Onkologia Katowice - PRATIA

    Katowice, Silesian Voivodeship, 40-523

    Active, not recruiting

  • N. Copernicus Provincial MCOT in Lodz

    Lodz, Łódź Voivodeship, 93-513

    Active, not recruiting

  • Instytut Hematologii i Transfuzjologii Klinika Zaburzen Hemostazy i Chorob Wewnetrznych

    Warsaw, Masovian Voivodeship, 02-776

    Active, not recruiting

Other trials in Poland

Norway3 sites, 1 recruiting

  • Universitetet i Bergen

    Bergen, 5021

    Site Contact, 47 55-97-50-00, galina.tsykunova@helse-bergen.no

    Galina Tsykunova

    Recruiting

  • Sykehuset Ostfold

    Grålum, 1714

    Active, not recruiting

  • Akershus Universitetssykehus

    Lorenskog, 1478

    Active, not recruiting

Other trials in Norway

France2 sites, 2 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

    Not yet recruiting

Other trials in France

Greece2 sites

  • Olympion General Clinic & Rehabilitation Center

    Pátrai, 264 43

    Active, not recruiting

  • General Hospital of Thessaloniki George Papanikolaou

    Thessaloniki, 570 10

    Active, not recruiting

Other trials in Greece

Netherlands2 sites

  • Erasmus Medical Center, Department of Hematology

    Rotterdam, South Holland, 3015 GD

    Active, not recruiting

  • Hagaziekenhuis

    The Hague, South Holland, 2545AA

    Active, not recruiting

Other trials in Netherlands

Sweden2 sites, 1 recruiting

  • Karolinska Universitetssjukhuset

    Huddinge, Stockholm County, 14186

    Active, not recruiting

  • Skanes University hospital, Hematology Department

    Malmö, 205 02

    Site Contact

    Alexandros Arvanitakis

    Not yet recruiting

Other trials in Sweden

Croatia1 site, 1 recruiting

  • Clinical Hospital Centar Zagreb

    Zagreb, 10000

    Site Contact

    Drazen Pulanic

    Not yet recruiting

Other trials in Croatia

Hong Kong1 site, 1 recruiting

  • Queen Mary Hospital

    Hong Kong, Pok Fu Lam

    Site Contact

    Yok Lam Kwong

    Recruiting

Other trials in Hong Kong

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).

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 groups in NCT06722235
Study groupRoleWhat they receive
MezagitamabExperimentalParticipants 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
PlaceboPlacebo comparatorParticipants 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.

  1. 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)

  1. 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

  2. Time to First Platelet Count ≥50,000/μL

    Measured: Up to Week 24

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Percentage of Participants Receiving Rescue Therapy

    Measured: Up to Week 24

  9. 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

  10. Serum Concentration of Mezagitamab During and After Intervention

    Measured: Predose on Day 1 and at multiple time points post-dose up to Day 169

  11. Number of Participants With Anti-drug Antibodies (ADA)

    Measured: Predose on Day 1 and at multiple time points post-dose up to Day 169

  12. Change in ADA Titers Over Time

    Measured: Up to Day 169

  13. 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.

  1. First posted9 Dec 2024
  2. Study start27 Feb 2025
  3. Primary completion16 Mar 2028 (estimated)
  4. Study completion16 Mar 2028 (estimated)

Resources

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)
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
Nov 2026
First submitted
5 Dec 2024
Last updated
4 Nov 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mezagitamab in people with Immune Thrombocytopenic Purpura (ITP), run by Takeda at 124 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in United States, China, Japan, Italy, Australia and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Durable Platelet Response (time frame: Up to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06722235, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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