A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults With Chronic Primary Immune Thrombocytopenia
2 other identifiers
interventional
150
14 countries
108
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2025
Typical duration for phase_3
108 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2025
CompletedFirst Posted
Study publicly available on registry
April 29, 2025
CompletedStudy Start
First participant enrolled
August 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 29, 2029
April 29, 2026
April 1, 2026
4 years
April 25, 2025
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to mezagitamab in the parent trial for Cohort 1 and in this trial for Cohort 2. A serious TEAE is a TEAE that meets 1 or more of the criteria: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or was otherwise considered medically important.
Up to approximately 108 weeks
Number of Participants With TEAEs Leading to Permanent Withdrawal of Mezagitamab
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to mezagitamab in the parent trial for Cohort 1 and in this trial for Cohort 2.
Up to approximately 108 weeks
Secondary Outcomes (10)
Duration of Platelet Response
Up to approximately 108 weeks
Duration Between On-Demand Treatment Courses
Up to approximately 108 weeks
Time to Initiation of the First On-Demand Treatment Course
Up to approximately 108 weeks
Number of Participants With Complete Response
Up to approximately 108 weeks
Number of Participants With Immune Thrombocytopenia (ITP) Remission
Up to approximately 108 weeks
- +5 more secondary outcomes
Study Arms (1)
Mezagitamab
EXPERIMENTALEligible 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.
Interventions
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- For TAK-079-3002 participants:
- \. 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:
- The participant has had any thrombotic or embolic event within 12 months before signing the ICF.
- The participant has had a splenectomy within 3 months before signing the ICF.
- The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), 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.
- 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 CD19+ count below the lower limit of normal.
- The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Visit 1.
- The participant has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.
- The participant has used anticoagulants (for example, vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to Visit 1.
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (108)
USC Norris Comprehensive Cancer Center - Keck Medicine of USC
Los Angeles, California, 90033, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007, United States
Emory University
Atlanta, Georgia, 30308, United States
The University of Iowa
Iowa City, Iowa, 52242, United States
University Of Louisville Brown Cancer Center
Louisville, Kentucky, 40202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27837, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program
Philadelphia, Pennsylvania, 19104, United States
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, 19140, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
University of Washingto
Seattle, Washington, 98109, United States
Versiti Wisconsin, Inc
Milwaukee, Wisconsin, 53226, United States
Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
Liverpool, New South Wales, 2170, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Monash University - Australian Centre for Blood Diseases (ACBD)
Melbourne, Victoria, 3004, Australia
The Alfred Hospital
Melbourne, Victoria, 3005, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Perth Blood Institute
West Perth, Western Australia, 6005, Australia
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, Sofia-Grad, 1606, Bulgaria
Medical Center "Fama Medical"
Plovdiv, 4002, Bulgaria
UMHAT Sv. Ivan Rilski
Sofia, 1431, Bulgaria
UMHAT SofiaMed, OOD
Sofia, 1750, Bulgaria
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, 6003, Bulgaria
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hebei, 430022, China
Henan Cancer Hospital
Zhengzhou, Henan, 450004, China
The First Affiliated Hospital of Soochow University - Shizijie Campus
Suzhou, Jiangsu, 215006, China
The First Affiliated Hospital of Nanchang University - Donghu Campus
Nanchang, Jiangxi, 330006, China
Shengjing Hospital of China Medical University - Nanhu Campus
Shenyang, Liaoning, 110004, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Jinshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 201508, China
West China Hospital Sichuan University
Chengdu, Sichuan, 610041, China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
Tianjin, Tianjin Municipality, 300020, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650101, China
Zhejiang Provincial Hospital of Chinese Medicine - Main
Hangzhou, Zhejiang, 310006, China
Clinical Hospital Centar Zagreb
Zagreb, 10000, Croatia
Queen Mary Hospital
Hong Kong, Pok Fu Lam, Hong Kong
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, 80131, Italy
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
Rome, Lazio, oo610, Italy
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
Catania, Sicily, 95122, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, 40123, Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
Milan, 20162, Italy
Fondazione IRCCS San Gerardo Dei Tintori
Monza, 20900, Italy
A.O.U. Maggiore della Carita
Novara, 28100, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, oo133, Italy
AOU Citta della Salute e della Scienza di Torino
Torino, 10126, Italy
Azienda sanitaria universitaria Giuliano Isontina
Trieste, 34129, Italy
Azienda ULSS 8 Berica - Ospedale San Bortolo
Vicenza, 36100, Italy
Chiba Aoba Municipal Hospital
Chuo-ku, Chiba, 260-0852, Japan
Chibaken Saiseikai Narashino Hospital
Narashino-shi, Chiba, 275-8580, Japan
National Hospital Organization Mito Medical Center
Ibaraki, Higashiibaraki-gun, 311-3193, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191, Japan
Hematology Ohta Clinic,Shinsaibashi
Osaka, Osaka, 542-0081, Japan
Osaka University Hospital
Suita-shi, Osaka, 565-0871, Japan
Saitama Medical University Hospital
Iruma-gun, Saitama, 350-0495, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8655, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, 173-8610, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku, Tokyo, 130-0022, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, 400-8506, Japan
Erasmus Medical Center, Department of Hematology
Rotterdam, South Holland, 3015 GD, Netherlands
Hagaziekenhuis
The Hague, South Holland, 2545AA, Netherlands
IN-VIVO sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048, Poland
Instytut Hematologii i Transfuzjologii Klinika Zaburzen Hemostazy i Chorob Wewnetrznych
Warsaw, Masovian Voivodeship, 02-776, Poland
Pratia Onkologia Katowice - PRATIA
Katowice, Silesian Voivodeship, 40-523, Poland
N. Copernicus Provincial MCOT in Lodz
Lodz, Łódź Voivodeship, 93-513, Poland
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Seoul National University Hospital (SNUH)
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Korea University Anam Hospital
Seoul, 2841, South Korea
Asan Medical Center
Seoul, 5505, South Korea
Hospital Universitario Fundacion Alcorcon
Alcorcón, Mardrid, 28922, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Mardrid, 28007, Spain
Hospital Universitario 12 de Octubre
Madrid, Mardrid, 28041, Spain
C.A.U de Burgos - Hospital Universitario de Burgos
Burgos, 9006, Spain
Hospital Universitario De Salaman
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology
Mamak, Ankara, 6620, Turkey (Türkiye)
Aydin Adnan Menderes University Medical Faculty-Hematology Department
Efeler, Aydın, 9100, Turkey (Türkiye)
Cerrahpasa Tip Fakultesi
Edirne, 22030, Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi Hastanesi
Edirne, 22030, Turkey (Türkiye)
Sakarya University Education and Research Hospital
Sakarya, 54290, Turkey (Türkiye)
University Hospitals of Leicester NHS Trust
Leicester, East Midlands, LE1 5WW, United Kingdom
Southampton General Hospital
Southampton, Hampshire, SO16 6YD, United Kingdom
Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust
Southwark, London, DE1 9RT, United Kingdom
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, Merseyside, L7 8XP, United Kingdom
Greater Glasgow Health Board
Glasgow, Scotland, G312ER, United Kingdom
University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, Yorkshire, LS9 TF, United Kingdom
Barts Health NHS Trust, Royal London Hospital
London, E11BB, United Kingdom
University College London Hospitals
London, NW1 2PG, United Kingdom
Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
Related Links
- 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.
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MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2025
First Posted
April 29, 2025
Study Start
August 14, 2025
Primary Completion (Estimated)
July 29, 2029
Study Completion (Estimated)
July 29, 2029
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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.