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New injection aims to stabilize platelets in chronic ITP patients

NCT ID NCT06722235

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 6 times

Summary

This Phase 3 trial tests whether mezagitamab, given as a shot under the skin, can safely keep platelet counts stable in adults with chronic ITP. ITP is a condition where the immune system destroys platelets, leading to easy bruising and bleeding. The study will compare mezagitamab to a placebo over 6 months in 171 participants who have not responded well to standard treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mezagitamab (also known as TAK-079), given as an injection under the skin
What this could lead to
If it works, this could offer a new treatment option for people with chronic ITP who have not responded well to standard therapies, helping to stabilize their platelet counts and reduce bleeding risk.
What could go wrong
This is still an early Phase 3 trial with 171 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 171 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. The participant has been diagnosed with ITP that has persisted for at least 12 months. 2. 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. 3. 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. 4. The participant has a mean platelet count of less than (\<)30,000/μL. 5. 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. 6. 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. Key Exclusion Criteria: 1. The participant has secondary ITP. 2. The participant has had any thrombotic or embolic event within 12 months before signing the informed consent form (ICF). 3. The participant has had a splenectomy. 4. The participant has active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV). 5. 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. 6. 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. 7. The participant has received anti-cluster of differentiation (CD) 20 treatment within 12 months before screening, and either of the following applies: 1. The last dose was received within 6 months before screening. 2. 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. 8. The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before screening. 9. 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. 10. The participant has used anticoagulants (e.g., vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to the first dose of trial treatment. 11. 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. 12. 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. 13. 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. 14. 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.

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Conditions

The condition(s) this trial relates to.

autoimmune disease autoimmune thrombocytopenic purpura blood platelet disease Cytopenia hematologic disorder Hemorrhage hemorrhagic disease immune system disorder purpura Purpura, Thrombocytopenic, Idiopathic Skin Manifestations thrombocytopenia thrombocytopenic purpura

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune thrombocytopenic purpura ( ITP )

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    121 sites in 18 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • A.O.U. Maggiore della Carita

    RECRUITING

    Novara, 28100, Italy

  • AOU Citta della Salute e della Scienza di Torino

    RECRUITING

    Torino, 10126, Italy

  • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

    NOT_YET_RECRUITING

    Milan, 20162, Italy

  • Akershus Universitetssykehus

    NOT_YET_RECRUITING

    Lorenskog, 1478, Norway

  • American Oncology Partners of Maryland, PA

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology

    RECRUITING

    Mamak, Ankara, 6620, Turkey (Türkiye)

  • Asan Medical Center

    RECRUITING

    Seoul, 5505, South Korea

  • Aydin Adnan Menderes University Medical Faculty-Hematology Department

    RECRUITING

    Efeler, Aydın, 9100, Turkey (Türkiye)

  • Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

    RECRUITING

    Catania, Sicily, 95122, Italy

  • Azienda Ospedaliera Universitaria Federico II

    NOT_YET_RECRUITING

    Naples, Campania, 80131, Italy

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    RECRUITING

    Bologna, 40123, Italy

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    NOT_YET_RECRUITING

    Rome, oo133, Italy

  • Azienda ULSS 8 Berica - Ospedale San Bortolo

    RECRUITING

    Vicenza, 36100, Italy

  • Azienda sanitaria universitaria Giuliano Isontina

    RECRUITING

    Trieste, 34129, Italy

  • Barts Health NHS Trust, Royal London Hospital

    RECRUITING

    London, E11BB, United Kingdom

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Canberra Hospital

    RECRUITING

    Garran, Australian Capital Territory, 2605, Australia

  • Cerrahpasa Tip Fakultesi

    RECRUITING

    Edirne, 22030, Turkey (Türkiye)

  • Chiba Aoba Municipal Hospital

    RECRUITING

    Chuo-ku, Chiba, 260-0852, Japan

  • Chibaken Saiseikai Narashino Hospital

    RECRUITING

    Narashino-shi, Chiba, 275-8580, Japan

  • Chu Dijon - Bourgogne

    NOT_YET_RECRUITING

    Dijon, Bourgogne-Franche-Comté, 1000, France

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinical Hospital Centar Zagreb

    NOT_YET_RECRUITING

    Zagreb, 10000, Croatia

  • Concord Repatriation General Hospital

    RECRUITING

    Concord, New South Wales, 2139, Australia

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27710, United States

  • East Carolina University

    RECRUITING

    Greenville, North Carolina, 27837, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Erasmus Medical Center, Department of Hematology

    RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Fondazione IRCCS San Gerardo Dei Tintori

    RECRUITING

    Monza, 20900, Italy

  • General Hospital of Thessaloniki George Papanikolaou

    RECRUITING

    Thessaloniki, 570 10, Greece

  • Genesis Cancer and Blood Institute - SCRI

    RECRUITING

    Hot Springs, Arkansas, 71913, United States

  • Georgetown University Medical Center - Lombardi Comprehensive Cancer Center

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Greater Glasgow Health Board

    RECRUITING

    Glasgow, Scotland, G312ER, United Kingdom

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, 510080, China

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

    RECRUITING

    Southwark, London, SE1 9RT, United Kingdom

  • Hagaziekenhuis

    RECRUITING

    The Hague, South Holland, 2545AA, Netherlands

  • Hematology Ohta Clinic,Shinsaibashi

    RECRUITING

    Osaka, Osaka, 542-0081, Japan

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450004, China

  • Hospital General Universitario Gregorio Maranon

    RECRUITING

    Madrid, Mardrid, 28007, Spain

  • Hospital Henri Mondor

    NOT_YET_RECRUITING

    Créteil, 94000, France

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Mardrid, 28041, Spain

  • Hospital Universitario De Salaman

    RECRUITING

    Salamanca, 37007, Spain

  • Hospital Universitario Fundacion Alcorcon

    RECRUITING

    Alcorcón, Mardrid, 28922, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • IN-VIVO sp. z o.o.

    WITHDRAWN

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048, Poland

  • Imperial College Healthcare NHS Trust

    RECRUITING

    London, W12 0HS, United Kingdom

  • Innovative Hematology, Inc.

    NOT_YET_RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Instytut Hematologii i Transfuzjologii Klinika Zaburzen Hemostazy i Chorob Wewnetrznych

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-776, Poland

  • Jinshan Hospital of Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 201508, China

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata-shi, Osaka, 573-1191, Japan

  • Karolinska Universitetssjukhuset

    RECRUITING

    Huddinge, Stockholm County, 14186, Sweden

  • Korea University Anam Hospital

    RECRUITING

    Seoul, 2841, South Korea

  • Kyungpook National University Hospital

    RECRUITING

    Daegu, 41944, South Korea

  • Leeds Teaching Hospitals NHS Trust

    RECRUITING

    Leeds, Yorkshire, LS9 TF, United Kingdom

  • Lewis Katz School of Medicine at Temple University

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medical Center "Fama Medical"

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • Memorial Sloan Kettering Cancer Center

    NOT_YET_RECRUITING

    New York, New York, 28204, United States

  • MidAmerica Cancer Center

    RECRUITING

    Kansas City, Missouri, 64132, United States

  • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

    RECRUITING

    Sofia, Sofia-Grad, 1606, Bulgaria

  • Monash University - Australian Centre for Blood Diseases (ACBD)

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Montefiore Medical Center

    NOT_YET_RECRUITING

    The Bronx, New York, 10461, United States

  • N. Copernicus Provincial MCOT in Lodz

    RECRUITING

    Lodz, Łódź Voivodeship, 93-513, Poland

  • National Hospital Organization Mito Medical Center

    RECRUITING

    Ibaraki, Higashiibaraki, 311-3193, Japan

  • Nihon University Itabashi Hospital

    RECRUITING

    Itabashi-ku, Tokyo, 173-8610, Japan

  • Olympion General Clinic & Rehabilitation Center

    RECRUITING

    Pátrai, 264 43, Greece

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • Osaka University Hospital

    RECRUITING

    Suita-shi, Osaka, 565-0871, Japan

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Perth Blood Institute

    RECRUITING

    West Perth, Western Australia, 6005, Australia

  • Peter MacCallum Cancer Centre

    NOT_YET_RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Pratia Onkologia Katowice - PRATIA

    RECRUITING

    Katowice, Silesian Voivodeship, 40-523, Poland

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250012, China

  • Queen Mary Hospital

    RECRUITING

    Hong Kong, Pok Fu Lam, Hong Kong

  • Rocky Mountain Cancer Center

    WITHDRAWN

    Denver, Colorado, 80218, United States

  • Royal Liverpool and Broadgreen University Hospitals NHS Trust

    RECRUITING

    Liverpool, Merseyside, L7 8XP, United Kingdom

  • Saitama Medical University Hospital

    RECRUITING

    Iruma-gun, Saitama, 350-0495, Japan

  • Sakarya University Education and Research Hospital

    NOT_YET_RECRUITING

    Sakarya, 54290, Turkey (Türkiye)

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital (SNUH)

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Shaanxi Provincial People's Hospital

    RECRUITING

    Xi'an, Shaanxi, 710068, China

  • Shengjing Hospital of China Medical University - Nanhu Campus

    RECRUITING

    Shenyang, Liaoning, 110004, China

  • Skanes University hospital, Hematology Department

    NOT_YET_RECRUITING

    Malmö, 205 02, Sweden

  • Southampton General Hospital

    RECRUITING

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • St George Hospital

    RECRUITING

    Kogarah, New South Wales, 2217, Australia

  • Sykehuset Ostfold

    NOT_YET_RECRUITING

    Grålum, 1714, Norway

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3005, Australia

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital of Nanchang University - Donghu Campus

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Soochow University - Shizijie Campus

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The First Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050031, China

  • The Second Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, Yunnan, 650101, China

  • The University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • The University of Tokyo Hospital

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8655, Japan

  • Tohoku University Hospital

    RECRUITING

    Sendai, Miyagi, 980-8574, Japan

  • Tokyo Metropolitan Bokutoh Hospital

    RECRUITING

    Sumida-ku, Tokyo, 130-0022, Japan

  • Trakya Universitesi Tip Fakultesi Hastanesi

    RECRUITING

    Edirne, 22030, Turkey (Türkiye)

  • UMHAT SofiaMed, OOD

    RECRUITING

    Sofia, 1750, Bulgaria

  • UMHAT Sv. Ivan Rilski

    RECRUITING

    Sofia, 1431, Bulgaria

  • USC Norris Comprehensive Cancer Center - Keck Medicine of USC

    RECRUITING

    Los Angeles, California, 90033, United States

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hebei, 430022, China

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

    RECRUITING

    Rome, Lazio, oo610, Italy

  • Universitetet i Bergen

    RECRUITING

    Bergen, 5021, Norway

  • University College London Hospitals

    RECRUITING

    London, NW1 2PG, United Kingdom

  • University Hospitals of Leicester NHS Trust

    RECRUITING

    Leicester, East Midlands, LE1 5WW, United Kingdom

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

    RECRUITING

    Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

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

    RECRUITING

    Stara Zagora, 6003, Bulgaria

  • University Of Louisville Brown Cancer Center

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of California San Diego Center for Bleeding and Clotting Disorders

    NOT_YET_RECRUITING

    San Diego, California, 92121, United States

  • University of Massachusetts Chan Medical School

    COMPLETED

    Worcester, Massachusetts, 01655, United States

  • University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • University of Washingto

    NOT_YET_RECRUITING

    Seattle, Washington, 98109, United States

  • Versiti Wisconsin, Inc

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • West China Hospital Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Yamanashi Prefectural Central Hospital

    RECRUITING

    Kofu, Yamanashi, 400-8506, Japan

  • Yokohama City University Medical Center

    RECRUITING

    Yokohama, Kanagawa, 232-0024, Japan

  • Zhejiang Provincial Hospital of Chinese Medicine - Main

    RECRUITING

    Hangzhou, Zhejiang, 310006, China

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