A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
NCT ID: NCT06722235
Last Updated: 2025-12-18
Study Results
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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RECRUITING
PHASE3
171 participants
INTERVENTIONAL
2025-02-27
2027-12-28
Brief Summary
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The participants will be treated with mezagitamab for up to 6 months.
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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Mezagitamab
Participants 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.
Mezagitamab
Mezagitamab injection administered SC.
Placebo
Participants will receive mezagitamab placebo-matching injection, SC, QW. They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses.
Placebo
Mezagitamab placebo-matching injection administered SC.
Interventions
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Mezagitamab
Mezagitamab injection administered SC.
Placebo
Mezagitamab placebo-matching injection administered SC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 \<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.
Exclusion Criteria
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 Day 1.
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.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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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
Rocky Mountain Cancer Center
Denver, Colorado, United States
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
The University of Iowa
Iowa City, Iowa, United States
University Of Louisville Brown Cancer Center
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Duke University Hospital
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program
Philadelphia, Pennsylvania, United States
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
University of Washingto
Seattle, Washington, United States
Versiti Wisconsin, Inc
Milwaukee, Wisconsin, United States
Canberra Hospital
Garran, Australian Capital Territory, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
Liverpool, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Monash University - Australian Centre for Blood Diseases (ACBD)
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Perth Blood Institute
West Perth, Western Australia, Australia
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, Sofia-Grad, Bulgaria
Medical Center "Fama Medical"
Plovdiv, , Bulgaria
UMHAT Sv. Ivan Rilski
Sofia, , Bulgaria
UMHAT SofiaMed, OOD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, , Bulgaria
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hebei, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Soochow University - Shizijie Campus
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University - Donghu Campus
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University - Nanhu Campus
Shenyang, Liaoning, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Jinshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Zhejiang Provincial Hospital of Chinese Medicine - Main
Hangzhou, Zhejiang, China
Clinical Hospital Centar Zagreb
Zagreb, , Croatia
Queen Mary Hospital
Hong Kong, Pok Fu Lam, Hong Kong
Chiba Aoba Municipal Hospital
Chuo-ku, Chiba, Japan
Chibaken Saiseikai Narashino Hospital
Narashino-shi, Chiba, Japan
National Hospital Organization Mito Medical Center
Ibaraki, Higashiibaraki, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
Hematology Ohta Clinic,Shinsaibashi
Osaka, Osaka, Japan
Osaka University Hospital
Suita-shi, Osaka, Japan
Saitama Medical University Hospital
Iruma-gun, Saitama, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku, Tokyo, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Erasmus Medical Center, Department of Hematology
Rotterdam, South Holland, Netherlands
Hagaziekenhuis
The Hague, South Holland, Netherlands
IN-VIVO sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Instytut Hematologii i Transfuzjologii Klinika Zaburzen Hemostazy i Chorob Wewnetrznych
Warsaw, Masovian Voivodeship, Poland
Pratia Onkologia Katowice - PRATIA
Katowice, Silesian Voivodeship, Poland
N. Copernicus Provincial MCOT in Lodz
Lodz, Łódź Voivodeship, Poland
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Seoul National University Hospital (SNUH)
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Universitario Fundacion Alcorcon
Alcorcón, Mardrid, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Mardrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Mardrid, Spain
Hospital Universitario De Salaman
Salamanca, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology
Mamak, Ankara, Turkey (Türkiye)
Aydin Adnan Menderes University Medical Faculty-Hematology Department
Efeler, Aydın, Turkey (Türkiye)
Cerrahpasa Tip Fakultesi
Edirne, , Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi Hastanesi
Edirne, , Turkey (Türkiye)
Sakarya University Education and Research Hospital
Sakarya, , Turkey (Türkiye)
University Hospitals of Leicester NHS Trust
Leicester, East Midlands, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, Merseyside, United Kingdom
Greater Glasgow Health Board
Glasgow, Scotland, United Kingdom
University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, Yorkshire, United Kingdom
Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust
London, , United Kingdom
Barts Health NHS Trust, Royal London Hospital
London, , United Kingdom
University College London Hospitals
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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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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2024-514401-54-00
Identifier Type: CTIS
Identifier Source: secondary_id
jRCT2031240667
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-079-3002
Identifier Type: -
Identifier Source: org_study_id