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RECRUITING

NCT06722235

PHASE3

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Sponsor: Takeda

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

171

Start Date

2025-02-27

Completion Date

2027-12-28

Last Updated

2026-04-08

Healthy Volunteers

Conditions

Immune Thrombocytopenic Purpura (ITP)

Interventions

DRUG

Mezagitamab

Mezagitamab injection administered SC.

DRUG

Placebo

Mezagitamab placebo-matching injection administered SC.

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 \<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.

Locations (112)

USC Norris Comprehensive Cancer Center - Keck Medicine of USC

Los Angeles, California, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Georgetown University Medical Center - Lombardi Comprehensive Cancer Center

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

Emory University

Atlanta, Georgia, United States

The University of Iowa

Iowa City, Iowa, United States

University Of Louisville Brown Cancer Center

Louisville, Kentucky, United States

American Oncology Partners of Maryland, PA

Bethesda, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Duke University Hospital

Durham, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Oregon Health & Science University

Portland, Oregon, United States

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

Philadelphia, Pennsylvania, United States

Lewis Katz School of Medicine at Temple University

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

University of Washingto

Seattle, Washington, United States

Versiti Wisconsin, Inc

Milwaukee, Wisconsin, United States

Canberra Hospital

Garran, Australian Capital Territory, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

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

Liverpool, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Monash University - Australian Centre for Blood Diseases (ACBD)

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Perth Blood Institute

West Perth, Western Australia, Australia

Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

Sofia, Sofia-Grad, Bulgaria

Medical Center "Fama Medical"

Plovdiv, Bulgaria

UMHAT Sv. Ivan Rilski

Sofia, Bulgaria

UMHAT SofiaMed, OOD

Sofia, Bulgaria

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

Stara Zagora, Bulgaria

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hebei, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Soochow University - Shizijie Campus

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University - Donghu Campus

Nanchang, Jiangxi, China

Shengjing Hospital of China Medical University - Nanhu Campus

Shenyang, Liaoning, China

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Jinshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

West China Hospital Sichuan University

Chengdu, Sichuan, China

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

Tianjin, Tianjin Municipality, China

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Zhejiang Provincial Hospital of Chinese Medicine - Main

Hangzhou, Zhejiang, China

Clinical Hospital Centar Zagreb

Zagreb, Croatia

Chu Dijon - Bourgogne

Dijon, Bourgogne-Franche-Comté, France

Hospital Henri Mondor

Créteil, France

Olympion General Clinic & Rehabilitation Center

Pátrai, Greece

General Hospital of Thessaloniki George Papanikolaou

Thessaloniki, Greece

Queen Mary Hospital

Hong Kong, Pok Fu Lam, Hong Kong

Azienda Ospedaliera Universitaria Federico II

Naples, Campania, Italy

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

Rome, Lazio, Italy

Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

Catania, Sicily, Italy

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Bologna, Italy

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

Milan, Italy

Fondazione IRCCS San Gerardo Dei Tintori

Monza, Italy

A.O.U. Maggiore della Carità

Novara, Italy

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, Italy

AOU Citta della Salute e della Scienza di Torino

Torino, Italy

Azienda sanitaria universitaria Giuliano Isontina

Trieste, Italy

Azienda ULSS 8 Berica - Ospedale San Bortolo

Vicenza, Italy

Chiba Aoba Municipal Hospital

Chuo-ku, Chiba, Japan

Chibaken Saiseikai Narashino Hospital

Narashino-shi, Chiba, Japan

National Hospital Organization Mito Medical Center

Ibaraki, Higashiibaraki, Japan

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

Hematology Ohta Clinic,Shinsaibashi

Osaka, Osaka, Japan

Osaka University Hospital

Suita-shi, Osaka, Japan

Saitama Medical University Hospital

Iruma-gun, Saitama, Japan

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, Japan

Tokyo Metropolitan Bokutoh Hospital

Sumida-ku, Tokyo, Japan

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, Japan

Erasmus Medical Center, Department of Hematology

Rotterdam, South Holland, Netherlands

Hagaziekenhuis

The Hague, South Holland, Netherlands

IN-VIVO sp. z o.o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Instytut Hematologii i Transfuzjologii Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych

Warsaw, Masovian Voivodeship, Poland

Pratia Onkologia Katowice - PRATIA

Katowice, Silesian Voivodeship, Poland

N. Copernicus Provincial MCOT in Lodz

Lodz, Łódź Voivodeship, Poland

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Seoul National University Hospital (SNUH)

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hospital Universitario Fundacion Alcorcon

Alcorcón, Mardrid, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Mardrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Mardrid, Spain

Hospital Universitario De Salaman

Salamanca, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology

Mamak, Ankara, Turkey (Türkiye)

Aydin Adnan Menderes University Medical Faculty-Hematology Department

Efeler, Aydın, Turkey (Türkiye)

Cerrahpasa Tip Fakultesi

Edirne, Turkey (Türkiye)

Trakya Universitesi Tip Fakultesi Hastanesi

Edirne, Turkey (Türkiye)

Sakarya University Education and Research Hospital

Sakarya, Turkey (Türkiye)

University Hospitals of Leicester NHS Trust

Leicester, East Midlands, United Kingdom

Southampton General Hospital

Southampton, Hampshire, United Kingdom

Royal Liverpool and Broadgreen University Hospitals NHS Trust

Liverpool, Merseyside, United Kingdom

Greater Glasgow Health Board

Glasgow, Scotland, United Kingdom

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

Stoke-on-Trent, Staffordshire, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire, United Kingdom

Barts Health NHS Trust, Royal London Hospital

London, United Kingdom

University College London Hospitals

London, United Kingdom

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

London, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom

Clinical Research Directory

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (112)