A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

NCT06722235 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: TAK-079-30022024-514401-54-00jRCT2031240667
• Study Type: interventional
• Target: 171
• Locations: 16 countries
• Sites: 112

Brief Summary

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a 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).

Conditions

Immune Thrombocytopenic Purpura (ITP)

Keywords

Thrombocytopenia; TAK-079; Blood Platelet Disorders; Hematologic Diseases; Cytopenia; Purpura; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Skin Manifestations; Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombocytopenic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Durable Platelet Response

  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 Outcomes (12)

• Cumulative Number of Weeks with a Platelet Count of ≥50,000/μL

  Up to Week 24

• Time to First Platelet Count ≥50,000/μL

  Up to Week 24

• The Cumulative Number of Weeks with a Platelet Count of ≥30,000/μL

  Up to Week 24

• Percentage of Participants with Complete Platelet Response

  Up to Week 24

• Percentage of Participants with Platelet Response at Week 16

  Week 16

Study Arms (2)

Mezagitamab

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Mezagitamab DRUG

Mezagitamab injection administered SC.

Also known as: TAK-079

Mezagitamab

Placebo DRUG

Mezagitamab placebo-matching injection administered SC.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant has been diagnosed with ITP that has persisted for at least 12 months.
• 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.
• 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.
• The participant has a mean platelet count of \<30,000/μL.
• 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.
• 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.

You may not qualify if:

• The participant has secondary ITP.
• The participant has had any thrombotic or embolic event within 12 months before signing the informed consent form (ICF).
• The participant has had a splenectomy.
• The participant has active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
• History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for treated non-melanoma skin cancer or cervical carcinoma in situ.
• In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
• The participant has received anti-cluster of differentiation (CD)20 treatment within 12 months before screening, and either of the following applies:
• The last dose was received within 6 months before screening.
• The last dose was received between 6, and 12 months before screening, and the participant has a cluster of differentiation 19 positive (CD19+) count below the lower limit of normal.
• The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Day 1.
• 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.
• The participant has used anticoagulants (e.g., vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to the first dose of trial treatment.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (112)

USC Norris Comprehensive Cancer Center - Keck Medicine of USC

Los Angeles, California, 90033, United States

RECRUITING

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

WITHDRAWN

Georgetown University Medical Center - Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Emory University

Atlanta, Georgia, 30308, United States

RECRUITING

The University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University Of Louisville Brown Cancer Center

Louisville, Kentucky, 40202, United States

RECRUITING

American Oncology Partners of Maryland, PA

Bethesda, Maryland, 20817, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

East Carolina University

Greenville, North Carolina, 27837, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Lewis Katz School of Medicine at Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

University of Washingto

Seattle, Washington, 98109, United States

NOT YET RECRUITING

Versiti Wisconsin, Inc

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

RECRUITING

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

RECRUITING

St George Hospital

Kogarah, New South Wales, 2217, Australia

RECRUITING

University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre

Liverpool, New South Wales, 2170, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

NOT YET RECRUITING

Monash University - Australian Centre for Blood Diseases (ACBD)

Melbourne, Victoria, 3004, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3005, Australia

RECRUITING

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

RECRUITING

Perth Blood Institute

West Perth, Western Australia, 6005, Australia

RECRUITING

Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

Sofia, Sofia-Grad, 1606, Bulgaria

RECRUITING

Medical Center "Fama Medical"

Plovdiv, 4002, Bulgaria

RECRUITING

UMHAT Sv. Ivan Rilski

Sofia, 1431, Bulgaria

RECRUITING

UMHAT SofiaMed, OOD

Sofia, 1750, Bulgaria

RECRUITING

University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD

Stara Zagora, 6003, Bulgaria

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hebei, 430022, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450004, China

RECRUITING

The First Affiliated Hospital of Soochow University - Shizijie Campus

Suzhou, Jiangsu, 215006, China

RECRUITING

The First Affiliated Hospital of Nanchang University - Donghu Campus

Nanchang, Jiangxi, 330006, China

RECRUITING

Shengjing Hospital of China Medical University - Nanhu Campus

Shenyang, Liaoning, 110004, China

RECRUITING

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710068, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Jinshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 201508, China

RECRUITING

West China Hospital Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650101, China

RECRUITING

Zhejiang Provincial Hospital of Chinese Medicine - Main

Hangzhou, Zhejiang, 310006, China

RECRUITING

Clinical Hospital Centar Zagreb

Zagreb, 10000, Croatia

NOT YET RECRUITING

Chu Dijon - Bourgogne

Dijon, Bourgogne-Franche-Comté, 1000, France

NOT YET RECRUITING

Hospital Henri Mondor

Créteil, 94000, France

NOT YET RECRUITING

Olympion General Clinic & Rehabilitation Center

Pátrai, 264 43, Greece

NOT YET RECRUITING

General Hospital of Thessaloniki George Papanikolaou

Thessaloniki, 570 10, Greece

NOT YET RECRUITING

Queen Mary Hospital

Hong Kong, Pok Fu Lam, Hong Kong

RECRUITING

Azienda Ospedaliera Universitaria Federico II

Naples, Campania, 80131, Italy

NOT YET RECRUITING

Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma

Rome, Lazio, oo610, Italy

RECRUITING

Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

Catania, Sicily, 95122, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Bologna, 40123, Italy

NOT YET RECRUITING

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

Milan, 20162, Italy

NOT YET RECRUITING

Fondazione IRCCS San Gerardo Dei Tintori

Monza, 20900, Italy

NOT YET RECRUITING

A.O.U. Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, oo133, Italy

NOT YET RECRUITING

AOU Citta della Salute e della Scienza di Torino

Torino, 10126, Italy

NOT YET RECRUITING

Azienda sanitaria universitaria Giuliano Isontina

Trieste, 34129, Italy

RECRUITING

Azienda ULSS 8 Berica - Ospedale San Bortolo

Vicenza, 36100, Italy

RECRUITING

Chiba Aoba Municipal Hospital

Chuo-ku, Chiba, 260-0852, Japan

RECRUITING

Chibaken Saiseikai Narashino Hospital

Narashino-shi, Chiba, 275-8580, Japan

RECRUITING

National Hospital Organization Mito Medical Center

Ibaraki, Higashiibaraki, 311-3193, Japan

RECRUITING

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

RECRUITING

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

RECRUITING

Kansai Medical University Hospital

Hirakata-shi, Osaka, 573-1191, Japan

RECRUITING

Hematology Ohta Clinic,Shinsaibashi

Osaka, Osaka, 542-0081, Japan

RECRUITING

Osaka University Hospital

Suita-shi, Osaka, 565-0871, Japan

RECRUITING

Saitama Medical University Hospital

Iruma-gun, Saitama, 350-0495, Japan

RECRUITING

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, 113-8655, Japan

RECRUITING

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, 173-8610, Japan

RECRUITING

Tokyo Metropolitan Bokutoh Hospital

Sumida-ku, Tokyo, 130-0022, Japan

RECRUITING

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, 400-8506, Japan

RECRUITING

Erasmus Medical Center, Department of Hematology

Rotterdam, South Holland, 3015 GD, Netherlands

NOT YET RECRUITING

Hagaziekenhuis

The Hague, South Holland, 2545AA, Netherlands

RECRUITING

IN-VIVO sp. z o.o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048, Poland

WITHDRAWN

Instytut Hematologii i Transfuzjologii Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych

Warsaw, Masovian Voivodeship, 02-776, Poland

NOT YET RECRUITING

Pratia Onkologia Katowice - PRATIA

Katowice, Silesian Voivodeship, 40-523, Poland

RECRUITING

N. Copernicus Provincial MCOT in Lodz

Lodz, Łódź Voivodeship, 93-513, Poland

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Kyungpook National University Hospital

Daegu, 41944, South Korea

RECRUITING

Seoul National University Hospital (SNUH)

Seoul, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, 2841, South Korea

RECRUITING

Asan Medical Center

Seoul, 5505, South Korea

RECRUITING

Hospital Universitario Fundacion Alcorcon

Alcorcón, Mardrid, 28922, Spain

RECRUITING

Hospital General Universitario Gregorio Maranon

Madrid, Mardrid, 28007, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Mardrid, 28041, Spain

RECRUITING

Hospital Universitario De Salaman

Salamanca, 37007, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

RECRUITING

Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology

Mamak, Ankara, 6620, Turkey (Türkiye)

NOT YET RECRUITING

Aydin Adnan Menderes University Medical Faculty-Hematology Department

Efeler, Aydın, 9100, Turkey (Türkiye)

NOT YET RECRUITING

Cerrahpasa Tip Fakultesi

Edirne, 22030, Turkey (Türkiye)

NOT YET RECRUITING

Trakya Universitesi Tip Fakultesi Hastanesi

Edirne, 22030, Turkey (Türkiye)

NOT YET RECRUITING

Sakarya University Education and Research Hospital

Sakarya, 54290, Turkey (Türkiye)

NOT YET RECRUITING

University Hospitals of Leicester NHS Trust

Leicester, East Midlands, LE1 5WW, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Royal Liverpool and Broadgreen University Hospitals NHS Trust

Liverpool, Merseyside, L7 8XP, United Kingdom

RECRUITING

Greater Glasgow Health Board

Glasgow, Scotland, G312ER, United Kingdom

RECRUITING

University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire, LS9 TF, United Kingdom

RECRUITING

Barts Health NHS Trust, Royal London Hospital

London, E11BB, United Kingdom

RECRUITING

University College London Hospitals

London, NW1 2PG, United Kingdom

RECRUITING

Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia; Blood Platelet Disorders; Hematologic Diseases; Cytopenia; Purpura; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Skin Manifestations; Purpura, Thrombocytopenic

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: February 27, 2025
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): December 28, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

GR (2); BU (5); PL (4); AU (10); JP (13); CR (1); TU (5); GB (10); CN (16); NL (2); FR (2); ES (5); US (18); IT (11); HK (1); KR (7)