New shot shows promise for Long-Term control of bleeding disorder

NCT ID NCT06948318

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This study tests the long-term safety of a drug called mezagitamab for adults with chronic immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, causing easy bruising and bleeding. About 150 participants who completed earlier mezagitamab studies will receive the drug as needed. Researchers will monitor side effects and how well the drug controls platelet levels over time.

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 150 people

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

Started

Aug 2025

Expected to finish

Jul 2029

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 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. * Key Exclusion criteria: 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: 1. The participant has had any thrombotic or embolic event within 12 months before signing the ICF. 2. The participant has had a splenectomy within 3 months before signing the ICF. 3. The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). 4. 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. 5. 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. 6. 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 CD19+ count below the lower limit of normal. 7. The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Visit 1. 8. The participant has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1. 9. 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Immune thrombocytopenic purpura ( ITP ) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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 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.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

116 sites in 15 countries. The list below names each one and where it is.
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 ↗
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

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

A.O.U. Maggiore della Carita
RECRUITING

Novara, 28100, Italy
AOU Citta della Salute e della Scienza di Torino
NOT_YET_RECRUITING

Torino, 10126, Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
NOT_YET_RECRUITING

Milan, 20162, Italy
American Oncology Partners of Maryland, PA
NOT_YET_RECRUITING

Morristown, New Jersey, 07960, United States
Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology
NOT_YET_RECRUITING

Mamak, Ankara, 6620, Turkey (Türkiye)
Asan Medical Center
NOT_YET_RECRUITING

Seoul, 5505, South Korea
Aydin Adnan Menderes University Medical Faculty-Hematology Department
NOT_YET_RECRUITING

Efeler, Aydın, 9100, Turkey (Türkiye)
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
NOT_YET_RECRUITING

Catania, Sicily, 95122, Italy
Azienda Ospedaliera Universitaria Federico II
NOT_YET_RECRUITING

Naples, Campania, 80131, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
NOT_YET_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
NOT_YET_RECRUITING

Houston, Texas, 77030, United States
C.A.U de Burgos - Hospital Universitario de Burgos
NOT_YET_RECRUITING

Burgos, 9006, Spain
Canberra Hospital
RECRUITING

Garran, Australian Capital Territory, 2605, Australia
Cerrahpasa Tip Fakultesi
NOT_YET_RECRUITING

Edirne, 22030, Turkey (Türkiye)
Chiba Aoba Municipal Hospital
NOT_YET_RECRUITING

Chuo-ku, Chiba, 260-0852, Japan
Chibaken Saiseikai Narashino Hospital
NOT_YET_RECRUITING

Narashino-shi, Chiba, 275-8580, Japan
Cleveland Clinic
NOT_YET_RECRUITING

Cleveland, Ohio, 44195, United States
Clinical Hospital Centar Zagreb
NOT_YET_RECRUITING

Zagreb, 10000, Croatia
Concord Repatriation General Hospital
NOT_YET_RECRUITING

Concord, New South Wales, 2139, Australia
Duke University Hospital
NOT_YET_RECRUITING

Durham, North Carolina, 27710, United States
East Carolina University
NOT_YET_RECRUITING

Greenville, North Carolina, 27837, United States
Emory University
NOT_YET_RECRUITING

Atlanta, Georgia, 30308, United States
Erasmus Medical Center, Department of Hematology
NOT_YET_RECRUITING

Rotterdam, South Holland, 3015 GD, Netherlands
Fiona Stanley Hospital
RECRUITING

Murdoch, Western Australia, 6150, Australia
Fondazione IRCCS San Gerardo Dei Tintori
NOT_YET_RECRUITING

Monza, 20900, Italy
General Hospital of Thessaloniki George Papanikolaou
RECRUITING

Thessaloniki, Greece
Genesis Cancer and Blood Institute - SCRI
NOT_YET_RECRUITING

Hot Springs, Arkansas, 71913, United States
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
NOT_YET_RECRUITING

Washington D.C., District of Columbia, 20007, United States
Greater Glasgow Health Board
NOT_YET_RECRUITING

Glasgow, Scotland, G312ER, United Kingdom
Guangdong Provincial People's Hospital
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510080, China
Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust
NOT_YET_RECRUITING

Southwark, London, DE1 9RT, United Kingdom
Hagaziekenhuis
NOT_YET_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
NOT_YET_RECRUITING

Madrid, Mardrid, 28007, Spain
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING

Madrid, Mardrid, 28041, Spain
Hospital Universitario De Salaman
NOT_YET_RECRUITING

Salamanca, 37007, Spain
Hospital Universitario Fundacion Alcorcon
NOT_YET_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
NOT_YET_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
Korea University Anam Hospital
RECRUITING

Seoul, 2841, South Korea
Kyungpook National University Hospital
NOT_YET_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
NOT_YET_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
NOT_YET_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
NOT_YET_RECRUITING

Lodz, Łódź Voivodeship, 93-513, Poland
National Hospital Organization Mito Medical Center
NOT_YET_RECRUITING

Ibaraki, Higashiibaraki, 311-3193, Japan
Nihon University Itabashi Hospital
RECRUITING

Itabashi-ku, Tokyo, 173-8610, Japan
Olympion General Clinic & Rehabilitation Center
NOT_YET_RECRUITING

Pátrai, 264 43, Greece
Oregon Health & Science University
RECRUITING

Portland, Oregon, 97239, United States
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
NOT_YET_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
NOT_YET_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
NOT_YET_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)
NOT_YET_RECRUITING

Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING

Seoul, 03722, South Korea
Shaanxi Provincial People's Hospital
NOT_YET_RECRUITING

Xi'an, Shaanxi, 710068, China
Shengjing Hospital of China Medical University - Nanhu Campus
NOT_YET_RECRUITING

Shenyang, Liaoning, 110004, China
Southampton General Hospital
RECRUITING

Southampton, Hampshire, SO16 6YD, United Kingdom
St George Hospital
RECRUITING

Kogarah, New South Wales, 2217, Australia
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
NOT_YET_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
NOT_YET_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
NOT_YET_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
NOT_YET_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
NOT_YET_RECRUITING

Rome, Lazio, oo610, Italy
University College London Hospitals
NOT_YET_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
NOT_YET_RECRUITING

Stara Zagora, 6003, Bulgaria
University Of Louisville Brown Cancer Center
NOT_YET_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
NOT_YET_RECRUITING

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
NOT_YET_RECRUITING

Milwaukee, Wisconsin, 53226, United States
Virginia Oncology Associates
NOT_YET_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
NOT_YET_RECRUITING

Yokohama, Kanagawa, 232-0024, Japan
Zhejiang Provincial Hospital of Chinese Medicine - Main
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310006, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.