A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

November 3, 2026 updated by: Takeda

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants With Chronic Primary Immune Thrombocytopenia

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

171

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Recruiting
        • Canberra Hospital
        • Principal Investigator:
          • Philip Choi
        • Contact:
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Concord Repatriation General Hospital
        • Principal Investigator:
          • Vivien Chen
        • Contact:
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • St George Hospital
        • Principal Investigator:
          • Silvia Zheng
        • Contact:
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Danny Hsu
      • Westmead, New South Wales, Australia, 2145
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Isaac Goncalves
      • Melbourne, Victoria, Australia, 3005
        • Recruiting
        • The Alfred Hospital
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Huyen Tran
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Monash University - Australian Centre for Blood Diseases (ACBD)
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Zane Kaplan
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Dominic Pepperell
      • West Perth, Western Australia, Australia, 6005
        • Recruiting
        • Perth Blood Institute
        • Principal Investigator:
          • Ross Baker
        • Contact:
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Active, not recruiting
        • Medical Center "Fama Medical"
      • Sofia, Bulgaria, 1431
        • Active, not recruiting
        • UMHAT Sv. Ivan Rilski
      • Sofia, Bulgaria, 1750
        • Active, not recruiting
        • UMHAT SofiaMed, OOD
      • Stara Zagora, Bulgaria, 6003
        • Active, not recruiting
        • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1606
        • Active, not recruiting
        • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Principal Investigator:
          • Tienan Zhu
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Completed
        • Guangdong Provincial People's Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Principal Investigator:
          • Peng Cheng
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050031
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Principal Investigator:
          • Qingchi Liu
        • Contact:
      • Wuhan, Hebei, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Principal Investigator:
          • Yu Hu
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450004
        • Recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • Hu Zhou
        • Contact:
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University - Shizijie Campus
        • Principal Investigator:
          • Jie Yin
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University - Donghu Campus
        • Principal Investigator:
          • Ruibin Huang
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital of China Medical University - Nanhu Campus
        • Principal Investigator:
          • Aijun Liao
        • Contact:
          • Site Contact
          • Phone Number: +8618940259833
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Completed
        • Shaanxi Provincial People's Hospital
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Principal Investigator:
          • Ming Hou
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201508
        • Recruiting
        • Jinshan Hospital of Fudan University
        • Principal Investigator:
          • Yunfeng Cheng
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital Sichuan University
        • Principal Investigator:
          • Yuping Gong
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Recruiting
        • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
        • Principal Investigator:
          • Yunfei Chen
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650101
        • Recruiting
        • The Second Affiliated Hospital of Kunming Medical University
        • Principal Investigator:
          • Zeping Zhou
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Completed
        • Zhejiang Provincial Hospital of Chinese Medicine - Main
  • Croatia
      • Zagreb, Croatia, 10000
        • Not yet recruiting
        • Clinical Hospital Centar Zagreb
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Drazen Pulanic
  • France
      • Créteil, France, 94000
        • Not yet recruiting
        • Hospital Henri Mondor
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Marc Michel
    • Bourgogne-Franche-Comté
      • Dijon, Bourgogne-Franche-Comté, France, 1000
        • Not yet recruiting
        • Chu Dijon - Bourgogne
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Bernard Bonnotte
  • Greece
      • Pátrai, Greece, 264 43
        • Active, not recruiting
        • Olympion General Clinic & Rehabilitation Center
      • Thessaloniki, Greece, 570 10
        • Active, not recruiting
        • General Hospital of Thessaloniki George Papanikolaou
  • Hong Kong
    • Pok Fu Lam
      • Hong Kong, Pok Fu Lam, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Yok Lam Kwong
  • Italy
      • Bologna, Italy, 40123
        • Active, not recruiting
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
      • Milan, Italy, 20162
        • Not yet recruiting
        • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Monica Carpenedo
      • Monza, Italy, 20900
        • Active, not recruiting
        • Fondazione IRCCS San Gerardo Dei Tintori
      • Novara, Italy, 28100
        • Active, not recruiting
        • A.O.U. Maggiore della Carita
      • Rome, Italy, oo133
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Francesco Buccisano
      • Torino, Italy, 10126
        • Active, not recruiting
        • AOU Citta della Salute e della Scienza di Torino
      • Trieste, Italy, 34129
        • Active, not recruiting
        • Azienda sanitaria universitaria Giuliano Isontina
      • Vicenza, Italy, 36100
        • Active, not recruiting
        • Azienda ULSS 8 Berica - Ospedale San Bortolo
    • Campania
      • Naples, Campania, Italy, 80131
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Federico II
        • Principal Investigator:
          • Fabrizio Pane
        • Contact:
    • Lazio
      • Rome, Lazio, Italy, oo610
        • Active, not recruiting
        • Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
    • Sicily
      • Catania, Sicily, Italy, 95122
        • Active, not recruiting
        • Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
  • Japan
    • Chiba
      • Chuo-ku, Chiba, Japan, 260-0852
        • Recruiting
        • Chiba Aoba Municipal Hospital
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Yokota Akira
      • Narashino-shi, Chiba, Japan, 275-8580
        • Recruiting
        • Chibaken Saiseikai Narashino Hospital
        • Principal Investigator:
          • Ryuko Cho
        • Contact:
    • Higashiibaraki
      • Ibaraki, Higashiibaraki, Japan, 311-3193
        • Recruiting
        • National Hospital Organization Mito Medical Center
        • Principal Investigator:
          • Chikashi Yoshida
        • Contact:
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Recruiting
        • Yokohama City University Medical Center
        • Principal Investigator:
          • Takuya Miyazaki
        • Contact:
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
        • Principal Investigator:
          • Noriko Fukuhara
        • Contact:
          • Site Contact
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital
        • Principal Investigator:
          • Tomoki Ito
        • Contact:
      • Osaka, Osaka, Japan, 542-0081
        • Recruiting
        • Hematology Ohta Clinic,Shinsaibashi
        • Principal Investigator:
          • Kensuke Ohta
        • Contact:
          • Site Contact
          • Phone Number: 81 6-6245-2117
      • Suita-shi, Osaka, Japan, 565-0871
        • Recruiting
        • Osaka University Hospital
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Kato Hisashi
    • Saitama
      • Iruma-gun, Saitama, Japan, 350-0495
        • Recruiting
        • Saitama Medical University Hospital
        • Principal Investigator:
          • Yoshitaka Miyakawa
        • Contact:
          • Site Contact
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • Recruiting
        • The University of Tokyo Hospital
        • Principal Investigator:
          • Mineo Kurokawa
        • Contact:
      • Sumida-ku, Tokyo, Japan, 130-0022
        • Recruiting
        • Tokyo Metropolitan Bokutoh Hospital
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Kosugi Nobuharu
      • tabashi City, Tokyo, Japan, 173-8610
        • Recruiting
        • Nihon University Itabashi Hospital
        • Contact:
        • Principal Investigator:
          • Otake Shimon
    • Yamanashi
      • Kofu, Yamanashi, Japan, 400-8506
        • Recruiting
        • Yamanashi Prefectural Central Hospital
        • Principal Investigator:
          • Masaki Iino
        • Contact:
          • Site Contact
          • Phone Number: 055-253-7111
  • Netherlands
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Active, not recruiting
        • Erasmus Medical Center, Department of Hematology
      • The Hague, South Holland, Netherlands, 2545AA
        • Active, not recruiting
        • Hagaziekenhuis
  • Norway
      • Bergen, Norway, 5021
        • Recruiting
        • Universitetet i Bergen
        • Principal Investigator:
          • Galina Tsykunova
        • Contact:
      • Grålum, Norway, 1714
        • Active, not recruiting
        • Sykehuset Ostfold
      • Lorenskog, Norway, 1478
        • Active, not recruiting
        • Akershus Universitetssykehus
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-048
        • Withdrawn
        • IN-VIVO sp. z o.o.
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-776
        • Active, not recruiting
        • Instytut Hematologii i Transfuzjologii Klinika Zaburzen Hemostazy i Chorob Wewnetrznych
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-523
        • Active, not recruiting
        • Pratia Onkologia Katowice - PRATIA
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-513
        • Active, not recruiting
        • N. Copernicus Provincial MCOT in Lodz
  • South Korea
      • Daegu, South Korea, 41944
        • Recruiting
        • Kyungpook National University Hospital
        • Principal Investigator:
          • Sang-Kyun Sohn
        • Contact:
          • Site Contact
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
          • Site Contact
        • Principal Investigator:
          • June-Won Cheong
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Jun Ho Jang
      • Seoul, South Korea, 5505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Je-Hwan Lee
      • Seoul, South Korea, 2841
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Yong Park
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital (SNUH)
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Youngil Koh
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Soo-Mee Bang
  • Spain
      • Madrid, Spain, 28007
        • Active, not recruiting
        • Hospital General Universitario Gregorio Maranon
      • Salamanca, Spain, 37007
        • Active, not recruiting
        • Hospital Universitario De Salaman
      • Seville, Spain, 41013
        • Active, not recruiting
        • Hospital Universitario Virgen del Rocio
    • Mardrid
      • Alcorcón, Mardrid, Spain, 28922
        • Active, not recruiting
        • Hospital Universitario Fundacion Alcorcon
      • Madrid, Mardrid, Spain, 28041
        • Active, not recruiting
        • Hospital Universitario 12 de Octubre
  • Sweden
      • Malmö, Sweden, 205 02
        • Not yet recruiting
        • Skanes University hospital, Hematology Department
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Alexandros Arvanitakis
    • Stockholm County
      • Huddinge, Stockholm County, Sweden, 14186
        • Active, not recruiting
        • Karolinska Universitetssjukhuset
  • Turkey (Türkiye)
      • Edirne, Turkey (Türkiye), 22030
        • Recruiting
        • Cerrahpasa Tip Fakultesi
        • Contact:
        • Principal Investigator:
          • Muhlis Cem Ar
      • Edirne, Turkey (Türkiye), 22030
        • Recruiting
        • Trakya Universitesi Tip Fakultesi Hastanesi
        • Contact:
        • Principal Investigator:
          • Ahmet Muzaffer Demir
      • Sakarya, Turkey (Türkiye), 54290
        • Not yet recruiting
        • Sakarya University Education and Research Hospital
        • Principal Investigator:
          • Tuba Hacibekiroglu
        • Contact:
    • Ankara
      • Mamak, Ankara, Turkey (Türkiye), 6620
        • Recruiting
        • Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology
        • Principal Investigator:
          • Selami Toprak
        • Contact:
    • Aydın
      • Efeler, Aydın, Turkey (Türkiye), 9100
        • Recruiting
        • Aydin Adnan Menderes University Medical Faculty-Hematology Department
        • Principal Investigator:
          • Irfan Yavasoglu
        • Contact:
  • United Kingdom
      • London, United Kingdom, NW1 2PG
        • Active, not recruiting
        • University College London Hospitals
      • London, United Kingdom, E11BB
        • Active, not recruiting
        • Barts Health NHS Trust, Royal London Hospital
      • London, United Kingdom, W12 0HS
        • Active, not recruiting
        • Imperial College Healthcare NHS Trust
    • East Midlands
      • Leicester, East Midlands, United Kingdom, LE1 5WW
        • Active, not recruiting
        • University Hospitals of Leicester NHS Trust
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Active, not recruiting
        • Southampton General Hospital
    • London
      • Southwark, London, United Kingdom, SE1 9RT
        • Active, not recruiting
        • Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8XP
        • Active, not recruiting
        • Royal Liverpool and Broadgreen University Hospitals NHS Trust
    • Scotland
      • Glasgow, Scotland, United Kingdom, G312ER
        • Active, not recruiting
        • Greater Glasgow Health Board
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • Active, not recruiting
        • University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom, LS9 TF
        • Active, not recruiting
        • Leeds Teaching Hospitals NHS Trust
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Recruiting
        • Genesis Cancer and Blood Institute - SCRI
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Lingyi Chen
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC Norris Comprehensive Cancer Center - Keck Medicine of USC
        • Principal Investigator:
          • Howard Liebman
        • Contact:
      • San Diego, California, United States, 92121
        • Not yet recruiting
        • University of California San Diego Center for Bleeding and Clotting Disorders
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Annette Von Drygalski
    • Colorado
      • Denver, Colorado, United States, 80218
        • Withdrawn
        • Rocky Mountain Cancer Center
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
        • Principal Investigator:
          • Catherine Broome
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Ana Antun
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Innovative Hematology, Inc.
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Sherwin Desouza
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • The University of Iowa
        • Principal Investigator:
          • Steven Lentz
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University Of Louisville Brown Cancer Center
        • Principal Investigator:
          • Kamila Cisak
        • Contact:
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • American Oncology Partners of Maryland, PA
        • Principal Investigator:
          • Ralph Boccia
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • David Kuter
        • Contact:
      • Worcester, Massachusetts, United States, 01655
        • Completed
        • University of Massachusetts Chan Medical School
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Recruiting
        • MidAmerica Cancer Center
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Benjamin Fangman
    • New York
      • New York, New York, United States, 28204
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Avi Leader
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • Irina Murakhovskaya
        • Contact:
          • Site Contact
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Hospital
        • Principal Investigator:
          • Ara Metjian
        • Contact:
      • Greenville, North Carolina, United States, 27837
        • Recruiting
        • East Carolina University
        • Principal Investigator:
          • Darla Liles
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Bethany Samuelson Bannow
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Principal Investigator:
          • Joseph Shatzel
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Lewis Katz School of Medicine at Temple University
        • Contact:
        • Principal Investigator:
          • Michael Bromberg
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program
        • Principal Investigator:
          • Adam Cuker
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Principal Investigator:
          • Senthil Sukumar
        • Contact:
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates
        • Principal Investigator:
          • Celeste Bremer
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Not yet recruiting
        • University of Washingto
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Sandhya Panch
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Versiti Wisconsin, Inc
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Lisa Kreuziger

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Mezagitamab

Mezagitamab injection administered SC.

Other Names:
  • TAK-079
Placebo Comparator: Placebo

Participants will receive mezagitamab-matching placebo injection, SC, QW. They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses.
Drug: Placebo

Mezagitamab-matching placebo injection administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Durable Platelet Response
Time Frame: Up to Week 24

Durable platelet response is defined as platelet count greater than or equal to (≥)50,000/microliter (μL) on at least 4 of the 6 weekly platelet measurements between Weeks 19 and 24.
Up to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Platelet Count ≥50,000/μL
Time Frame: Up to Week 24
Up to Week 24
Percentage of Participants Receiving Rescue Therapy
Time Frame: Up to Week 24
Up to Week 24
Change in ADA Titers Over Time
Time Frame: Up to Day 169
Up to Day 169
Serum Concentration of Mezagitamab During and After Intervention
Time Frame: Predose on Day 1 and at multiple time points post-dose up to Day 169
Predose on Day 1 and at multiple time points post-dose up to Day 169
Number of Participants With Anti-drug Antibodies (ADA)
Time Frame: Predose on Day 1 and at multiple time points post-dose up to Day 169
Predose on Day 1 and at multiple time points post-dose up to Day 169
Number of Participants With Neutralizing ADA
Time Frame: Predose on Day 1 and at multiple time points post-dose up to Day 169
Predose on Day 1 and at multiple time points post-dose up to Day 169
Cumulative Number of Weeks With a Platelet Count of ≥50,000/μL
Time Frame: Up to Week 24

The cumulative number of weeks in which the platelet count is ≥50,000/μL through Week 24.
Up to Week 24
Cumulative Number of Weeks With a Platelet Count of ≥30,000/μL
Time Frame: Up to Week 24

The cumulative number of weeks in which the platelet count is ≥30,000/μL, and at least doubled from baseline through Week 24.
Up to Week 24
Percentage of Participants With Complete Platelet Response
Time Frame: Up to Week 24

Complete platelet response is defined as a platelet count ≥100,000/μL on at least 2 visits through Week 24.
Up to Week 24
Percentage of Participants With Platelet Response at Week 16
Time Frame: Week 16

Platelet response is defined as a platelet count ≥50,000/μL before investigational medicinal product (IMP) administration at the Week 16 visit.
Week 16
Change from Baseline in the Symptoms Domain Score of the Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) at Weeks 16 and 24
Time Frame: Weeks 16 and 24

ITP-PAQ is a 44-item participant reported outcome (PRO) measure that assesses disease-specific health-related quality of life (HRQoL) that includes 10 domains: Symptoms, Fatigue/Sleep, Physical Health - Bother, Physical Health - Activity, Emotional Health - Psychological, Emotional Health - Fear, Overall Quality of Life (QoL), Social Activity, Women's Reproductive Health (including Fertility subscale, and Menstrual Symptoms subscale), and Work. The 6-item symptoms domain is scored from 0 to 100, with a positive change from baseline representing improvement of symptoms.
Weeks 16 and 24
Change from Baseline in Physical Fatigue (Item 10) Score of the ITP-PAQ at Weeks 16 and 24
Time Frame: Weeks 16 and 24

ITP-PAQ is a 44-item participant reported outcome (PRO) measure that assesses disease-specific health-related quality of life (HRQoL) that includes 10 domains: Symptoms, Fatigue/Sleep, Physical Health - Bother, Physical Health - Activity, Emotional Health - Psychological, Emotional Health - Fear, Overall Quality of Life (QoL), Social Activity, Women's Reproductive Health (including Fertility subscale, and Menstrual Symptoms subscale), and Work. Physical fatigue is scored from 0 to 100, with a positive change from baseline representing improvement in physical fatigue.
Weeks 16 and 24
Percentage of Participants With Bleeding Events
Time Frame: Up to Week 24

Bleeding events are defined as Grade ≥2 in the skin domain, or Grade ≥1 in the mucosal domain, or Grade ≥1 in the organ domain, in the immune thrombocytopenia-specific bleeding assessment tool (ITP-BAT) through Week 24.
Up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2025

Primary Completion (Estimated)

March 16, 2028

Study Completion (Estimated)

March 16, 2028

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-079-3002
  • 2024-514401-54-00 (Ctis)
  • jRCT2031240667 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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