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RECRUITING Phase 3 ClinicalTrials.gov

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Sponsor: Takeda • ClinicalTrials.gov ID: NCT06722235

Registry updated: 2026-09-18
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Description

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 low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously \[SC\]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it. 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).

Interventions

  • Mezagitamab (Drug)
    Mezagitamab injection administered SC.
  • Placebo (Drug)
    Mezagitamab-matching placebo injection administered SC.

Eligibility criteria

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.

Conditions

Immune Thrombocytopenic Purpura (ITP)

Locations

  • Genesis Cancer and Blood Institute - SCRI — Hot Springs, Arkansas, United States
  • USC Norris Comprehensive Cancer Center - Keck Medicine of USC — Los Angeles, California, United States
  • University of California San Diego Center for Bleeding and Clotting Disorders — San Diego, 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
  • Innovative Hematology, Inc. — Indianapolis, Indiana, United States
  • The University of Iowa — Iowa City, Iowa, United States
  • University Of Louisville Brown Cancer Center — Louisville, Kentucky, United States
  • American Oncology Partners of Maryland, PA — Bethesda, Maryland, United States
  • Massachusetts General Hospital — Boston, Massachusetts, United States
  • University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States
  • MidAmerica Cancer Center — Kansas City, Missouri, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Montefiore Medical Center — The Bronx, New York, United States
  • Duke University Hospital — Durham, North Carolina, United States
  • East Carolina University — Greenville, North Carolina, United States
  • Cleveland Clinic — Cleveland, Ohio, 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
  • Chu Dijon - Bourgogne — Dijon, Bourgogne-Franche-Comté, France
  • Hospital Henri Mondor — Créteil, France
  • Olympion General Clinic & Rehabilitation Center — Pátrai, Greece
  • General Hospital of Thessaloniki George Papanikolaou — Thessaloniki, Greece
  • Queen Mary Hospital — Hong Kong, Pok Fu Lam, Hong Kong
  • Azienda Ospedaliera Universitaria Federico II — Naples, Campania, Italy
  • Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma — Rome, Lazio, Italy
  • Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi — Catania, Sicily, Italy
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi — Bologna, Italy
  • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda — Milan, Italy
  • Fondazione IRCCS San Gerardo Dei Tintori — Monza, Italy
  • A.O.U. Maggiore della Carita — Novara, Italy
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata — Rome, Italy
  • AOU Citta della Salute e della Scienza di Torino — Torino, Italy
  • Azienda sanitaria universitaria Giuliano Isontina — Trieste, Italy
  • Azienda ULSS 8 Berica - Ospedale San Bortolo — Vicenza, Italy
  • 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
  • Universitetet i Bergen — Bergen, Norway
  • Sykehuset Ostfold — Grålum, Norway
  • Akershus Universitetssykehus — Lorenskog, Norway
  • 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
  • Karolinska Universitetssjukhuset — Huddinge, Stockholm County, Sweden
  • Skanes University hospital, Hematology Department — Malmö, Sweden
  • 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
  • Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust — Southwark, London, 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
  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record