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A Continuation Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

NCT ID: NCT06948318

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-14

Study Completion Date

2029-07-29

Brief Summary

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Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a lower number of platelets, making it easier to bruise or bleed. The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time.

Participants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met.

During the study, participants will visit their study clinic several times.

Detailed Description

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Conditions

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Immune Thrombocytopenic Purpura (ITP)

Keywords

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TAK-079 Immune Thrombocytopenia Chronic Primary Immune Thrombocytopenia Blood Platelet Disorders Hematologic Diseases Cytopenia Purpura Hemorrhagic Disorders Autoimmune Diseases Immune System Diseases Hemorrhage Skin Manifestations Purpura, Thrombocytopenic, Idiopathic Purpura, Thrombocytopenic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mezagitamab

Eligible participants who completed the TAK-079-3002 or TAK-079-1004 studies can receive on-demand treatment in this continuation study. The on-demand treatment course may be repeated as needed based on the pre-specified on-demand dosing criteria and investigator's clinical judgement.

Group Type EXPERIMENTAL

Mezagitamab

Intervention Type DRUG

Mezagitamab injection administered SC.

Interventions

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Mezagitamab

Mezagitamab injection administered SC.

Intervention Type DRUG

Other Intervention Names

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TAK-079

Eligibility Criteria

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Inclusion Criteria

1\. The participant has completed TAK-079-3002 (end of trial \[EOT\]) or TAK-079-1004 (EOT).

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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USC Norris Comprehensive Cancer Center - Keck Medicine of USC

Los Angeles, California, United States

Site Status NOT_YET_RECRUITING

Rocky Mountain Cancer Center

Denver, Colorado, United States

Site Status WITHDRAWN

Georgetown University Medical Center - Lombardi Comprehensive Cancer Center

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

Site Status NOT_YET_RECRUITING

Emory University

Atlanta, Georgia, United States

Site Status NOT_YET_RECRUITING

The University of Iowa

Iowa City, Iowa, United States

Site Status NOT_YET_RECRUITING

University Of Louisville Brown Cancer Center

Louisville, Kentucky, United States

Site Status NOT_YET_RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Duke University Hospital

Durham, North Carolina, United States

Site Status NOT_YET_RECRUITING

East Carolina University

Greenville, North Carolina, United States

Site Status NOT_YET_RECRUITING

Oregon Health & Science University

Portland, Oregon, United States

Site Status NOT_YET_RECRUITING

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

Philadelphia, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Lewis Katz School of Medicine at Temple University

Philadelphia, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Baylor College of Medicine

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status NOT_YET_RECRUITING

University of Washingto

Seattle, Washington, United States

Site Status NOT_YET_RECRUITING

Versiti Wisconsin, Inc

Milwaukee, Wisconsin, United States

Site Status NOT_YET_RECRUITING

Canberra Hospital

Garran, Australian Capital Territory, Australia

Site Status NOT_YET_RECRUITING

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Site Status NOT_YET_RECRUITING

St George Hospital

Kogarah, New South Wales, Australia

Site Status RECRUITING

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

Liverpool, New South Wales, Australia

Site Status NOT_YET_RECRUITING

Westmead Hospital

Westmead, New South Wales, Australia

Site Status RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status NOT_YET_RECRUITING

Monash University - Australian Centre for Blood Diseases (ACBD)

Melbourne, Victoria, Australia

Site Status NOT_YET_RECRUITING

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Site Status NOT_YET_RECRUITING

Perth Blood Institute

West Perth, Western Australia, Australia

Site Status RECRUITING

Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

Sofia, Sofia-Grad, Bulgaria

Site Status NOT_YET_RECRUITING

Medical Center "Fama Medical"

Plovdiv, , Bulgaria

Site Status NOT_YET_RECRUITING

UMHAT Sv. Ivan Rilski

Sofia, , Bulgaria

Site Status NOT_YET_RECRUITING

UMHAT SofiaMed, OOD

Sofia, , Bulgaria

Site Status NOT_YET_RECRUITING

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

Stara Zagora, , Bulgaria

Site Status NOT_YET_RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hebei, China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

The First Affiliated Hospital of Soochow University - Shizijie Campus

Suzhou, Jiangsu, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Nanchang University - Donghu Campus

Nanchang, Jiangxi, China

Site Status RECRUITING

Shengjing Hospital of China Medical University - Nanhu Campus

Shenyang, Liaoning, China

Site Status NOT_YET_RECRUITING

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

Site Status NOT_YET_RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Jinshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

West China Hospital Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

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

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Site Status NOT_YET_RECRUITING

Zhejiang Provincial Hospital of Chinese Medicine - Main

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Clinical Hospital Centar Zagreb

Zagreb, , Croatia

Site Status NOT_YET_RECRUITING

Queen Mary Hospital

Hong Kong, Pok Fu Lam, Hong Kong

Site Status NOT_YET_RECRUITING

Chiba Aoba Municipal Hospital

Chuo-ku, Chiba, Japan

Site Status NOT_YET_RECRUITING

Chibaken Saiseikai Narashino Hospital

Narashino-shi, Chiba, Japan

Site Status NOT_YET_RECRUITING

National Hospital Organization Mito Medical Center

Ibaraki, Higashiibaraki, Japan

Site Status NOT_YET_RECRUITING

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Site Status NOT_YET_RECRUITING

Tohoku University Hospital

Sendai, Miyagi, Japan

Site Status RECRUITING

Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

Site Status NOT_YET_RECRUITING

Hematology Ohta Clinic,Shinsaibashi

Osaka, Osaka, Japan

Site Status NOT_YET_RECRUITING

Osaka University Hospital

Suita-shi, Osaka, Japan

Site Status NOT_YET_RECRUITING

Saitama Medical University Hospital

Iruma-gun, Saitama, Japan

Site Status RECRUITING

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

Site Status NOT_YET_RECRUITING

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, Japan

Site Status RECRUITING

Tokyo Metropolitan Bokutoh Hospital

Sumida-ku, Tokyo, Japan

Site Status RECRUITING

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, Japan

Site Status NOT_YET_RECRUITING

Erasmus Medical Center, Department of Hematology

Rotterdam, South Holland, Netherlands

Site Status NOT_YET_RECRUITING

Hagaziekenhuis

The Hague, South Holland, Netherlands

Site Status NOT_YET_RECRUITING

IN-VIVO sp. z o.o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status WITHDRAWN

Instytut Hematologii i Transfuzjologii Klinika Zaburzen Hemostazy i Chorob Wewnetrznych

Warsaw, Masovian Voivodeship, Poland

Site Status NOT_YET_RECRUITING

Pratia Onkologia Katowice - PRATIA

Katowice, Silesian Voivodeship, Poland

Site Status NOT_YET_RECRUITING

N. Copernicus Provincial MCOT in Lodz

Lodz, Łódź Voivodeship, Poland

Site Status NOT_YET_RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status NOT_YET_RECRUITING

Kyungpook National University Hospital

Daegu, , South Korea

Site Status NOT_YET_RECRUITING

Seoul National University Hospital (SNUH)

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Korea University Anam Hospital

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Hospital Universitario Fundacion Alcorcon

Alcorcón, Mardrid, Spain

Site Status NOT_YET_RECRUITING

Hospital General Universitario Gregorio Maranon

Madrid, Mardrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Mardrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario De Salaman

Salamanca, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status NOT_YET_RECRUITING

Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology

Mamak, Ankara, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Aydin Adnan Menderes University Medical Faculty-Hematology Department

Efeler, Aydın, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Cerrahpasa Tip Fakultesi

Edirne, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Trakya Universitesi Tip Fakultesi Hastanesi

Edirne, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Sakarya University Education and Research Hospital

Sakarya, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

University Hospitals of Leicester NHS Trust

Leicester, East Midlands, United Kingdom

Site Status NOT_YET_RECRUITING

Southampton General Hospital

Southampton, Hampshire, United Kingdom

Site Status NOT_YET_RECRUITING

Royal Liverpool and Broadgreen University Hospitals NHS Trust

Liverpool, Merseyside, United Kingdom

Site Status NOT_YET_RECRUITING

Greater Glasgow Health Board

Glasgow, Scotland, United Kingdom

Site Status NOT_YET_RECRUITING

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

Stoke-on-Trent, Staffordshire, United Kingdom

Site Status NOT_YET_RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire, United Kingdom

Site Status NOT_YET_RECRUITING

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

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Barts Health NHS Trust, Royal London Hospital

London, , United Kingdom

Site Status RECRUITING

University College London Hospitals

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Bulgaria China Croatia Hong Kong Japan Netherlands Poland South Korea Spain Turkey (Türkiye) United Kingdom

Central Contacts

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Takeda Contact

Role: CONTACT

Phone: +1-877-825-3327

Email: [email protected]

Facility Contacts

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Related Links

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https://clinicaltrials.takeda.com/study-detail/a3da95a29a994831??page=1&idFilter=TAK-079-3003

Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

Other Identifiers

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2025-521692-31-00

Identifier Type: CTIS

Identifier Source: secondary_id

TAK-079-3003

Identifier Type: -

Identifier Source: org_study_id