A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

May 20, 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
        • Not yet 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
        • Recruiting
        • Medical Center "Fama Medical"
        • Contact:
        • Principal Investigator:
          • Katya Sapunarova
      • Sofia, Bulgaria, 1431
        • Recruiting
        • UMHAT Sv. Ivan Rilski
        • Principal Investigator:
          • Atanas Radinoff
        • Contact:
      • Sofia, Bulgaria, 1750
        • Recruiting
        • UMHAT SofiaMed, OOD
        • Principal Investigator:
          • Tzvetan Alaykov
        • Contact:
      • Stara Zagora, Bulgaria, 6003
        • Recruiting
        • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
        • Principal Investigator:
          • Mariya Todorova
        • Contact:
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1606
        • Recruiting
        • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
        • Principal Investigator:
          • Viktoria Barbukova
        • Contact:
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Principal Investigator:
          • Tienan Zhu
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Principal Investigator:
          • Chengwei Luo
        • Contact:
    • 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:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Yi Wang
    • 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
        • Recruiting
        • Zhejiang Provincial Hospital of Chinese Medicine - Main
        • Principal Investigator:
          • Baodong Ye
        • Contact:
  • 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
        • Recruiting
        • Olympion General Clinic & Rehabilitation Center
        • Principal Investigator:
          • Argiris Symeonidis
        • Contact:
      • Thessaloniki, Greece, 570 10
        • Recruiting
        • General Hospital of Thessaloniki George Papanikolaou
        • Principal Investigator:
          • Antonia Syrigou
        • Contact:
  • 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
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
        • Principal Investigator:
          • FRANCESCA PALANDRI
        • Contact:
          • Site Contact
      • 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
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Filippo Achille Brioschi
      • Novara, Italy, 28100
        • Recruiting
        • A.O.U. Maggiore della Carità
        • Principal Investigator:
          • Andrea Patriarca
        • Contact:
      • Rome, Italy, oo133
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Francesco Buccisano
      • Torino, Italy, 10126
        • Not yet recruiting
        • AOU Citta della Salute e della Scienza di Torino
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Alessandra Borchiellini
      • Trieste, Italy, 34129
      • Vicenza, Italy, 36100
        • Recruiting
        • Azienda ULSS 8 Berica - Ospedale San Bortolo
        • Principal Investigator:
          • Giuseppe Carli
        • Contact:
    • Campania
      • Naples, Campania, Italy, 80131
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Federico Ii
        • Principal Investigator:
          • Fabrizio Pane
        • Contact:
    • Lazio
      • Rome, Lazio, Italy, oo610
        • Recruiting
        • Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Cristina Santoro
    • Sicily
      • Catania, Sicily, Italy, 95122
        • Recruiting
        • Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
        • Principal Investigator:
          • Ugo Consoli
        • Contact:
  • 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-gun
      • Ibaraki, Higashiibaraki-gun, 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:
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Recruiting
        • Nihon University Itabashi Hospital
        • Contact:
        • Principal Investigator:
          • Otake Shimon
      • Sumida-ku, Tokyo, Japan, 130-0022
        • Recruiting
        • Tokyo Metropolitan Bokutoh Hospital
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Kosugi Nobuharu
    • 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
        • Not yet recruiting
        • Erasmus Medical Center, Department of Hematology
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Arend Jan Gerard Jansen
      • The Hague, South Holland, Netherlands, 2545AA
        • Recruiting
        • HagaZiekenhuis
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Tanja Netelenbos
  • 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
        • Recruiting
        • Instytut Hematologii i Transfuzjologii Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych
        • Principal Investigator:
          • Jerzy Windyga
        • Contact:
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-523
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-513
        • Recruiting
        • N. Copernicus Provincial MCOT in Lodz
        • Principal Investigator:
          • Jacek Trelinski
        • Contact:
  • 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
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario De Salaman
        • Principal Investigator:
          • Jose Ramon Gonzalez-Porras
        • Contact:
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Maria Eva Mingot Castellano
        • Contact:
    • Mardrid
      • Alcorcón, Mardrid, Spain, 28922
        • Recruiting
        • Hospital Universitario Fundacion Alcorcon
        • Principal Investigator:
          • Francisco Javier Penalver Parraga
        • Contact:
      • Madrid, Mardrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Denis Zafra Torres
        • Contact:
      • Madrid, Mardrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
        • Principal Investigator:
          • Cristina Pascual Izquierdo
        • Contact:
  • 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
        • Not yet recruiting
        • Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology
        • Principal Investigator:
          • Selami Toprak
        • Contact:
    • Aydın
      • Efeler, Aydın, Turkey (Türkiye), 9100
        • Not yet recruiting
        • Aydin Adnan Menderes University Medical Faculty-Hematology Department
        • Principal Investigator:
          • Irfan Yavasoglu
        • Contact:
  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Nicola Cooper
      • London, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospitals
        • Principal Investigator:
          • Marie Ann Scully
        • Contact:
      • London, United Kingdom, E11BB
        • Recruiting
        • Barts Health NHS Trust, Royal London Hospital
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Chen Frederick
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust
        • Principal Investigator:
          • Vickie McDonald
        • Contact:
    • East Midlands
      • Leicester, East Midlands, United Kingdom, LE1 5WW
        • Recruiting
        • University Hospitals of Leicester NHS Trust
        • Principal Investigator:
          • Mamta Garg
        • Contact:
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton General Hospital
        • Principal Investigator:
          • Rashid Kazmi
        • Contact:
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8XP
        • Recruiting
        • Royal Liverpool and Broadgreen University Hospitals NHS Trust
        • Principal Investigator:
          • David Simcox
        • Contact:
    • Scotland
      • Glasgow, Scotland, United Kingdom, G312ER
        • Recruiting
        • Greater Glasgow Health Board
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Bagot Catherine
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • Recruiting
        • University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
        • Principal Investigator:
          • David Sutton
        • Contact:
    • Yorkshire
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC Norris Comprehensive Cancer Center - Keck Medicine of USC
        • Principal Investigator:
          • Howard Liebman
        • Contact:
          • Site Contact
    • 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:
          • Site Contact
    • 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
        • Not yet recruiting
        • American Oncology Partners of Maryland, PA
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Ralph Boccia
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • David Kuter
        • Contact:
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts Chan Medical School
        • Principal Investigator:
          • Daniel Winokur
        • 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
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Darla Liles
    • 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
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Senthil Sukumar
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Celeste Bremer
    • 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
        • Not yet 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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 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.

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
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
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

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)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 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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