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NCT06722235PHASE3Recruiting

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Takeda

Start Date

2/27/2025

Completion Date

3/16/2028

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Mezagitamab

DRUG

Placebo

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Conditions

Immune Thrombocytopenic Purpura (ITP)

Locations

USC Norris Comprehensive Cancer Center - Keck Medicine of USC

Los Angeles, California 90033

United States

Rocky Mountain Cancer Center

Denver, Colorado 80218

United States

Georgetown University Medical Center - Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia 20007

United States

Emory University

Atlanta, Georgia 30308

United States

The University of Iowa

Iowa City, Iowa 52242

United States

University Of Louisville Brown Cancer Center

Louisville, Kentucky 40202

United States

American Oncology Partners of Maryland, PA

Bethesda, Maryland 20817

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts 01655

United States

Duke University Hospital

Durham, North Carolina 27710

United States

East Carolina University

Greenville, North Carolina 27837

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

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

Philadelphia, Pennsylvania 19104

United States

Lewis Katz School of Medicine at Temple University

Philadelphia, Pennsylvania 19140

United States

Baylor College of Medicine

Houston, Texas 77030

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

University of Washingto

Seattle, Washington 98109

United States

Versiti Wisconsin, Inc

Milwaukee, Wisconsin 53226

United States

Canberra Hospital

Garran, Australian Capital Territory 2605

Australia

Concord Repatriation General Hospital

Concord, New South Wales 2139

Australia

St George Hospital

Kogarah, New South Wales 2217

Australia

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

Liverpool, New South Wales 2170

Australia

Westmead Hospital

Westmead, New South Wales 2145

Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria 3000

Australia

Monash University - Australian Centre for Blood Diseases (ACBD)

Melbourne, Victoria 3004

Australia

The Alfred Hospital

Melbourne, Victoria 3005

Australia

Fiona Stanley Hospital

Murdoch, Western Australia 6150

Australia

Perth Blood Institute

West Perth, Western Australia 6005

Australia

Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

Sofia, Sofia-Grad 1606

Bulgaria

Medical Center "Fama Medical"

Plovdiv, 4002

Bulgaria

UMHAT Sv. Ivan Rilski

Sofia, 1431

Bulgaria

UMHAT SofiaMed, OOD

Sofia, 1750

Bulgaria

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

Stara Zagora, 6003

Bulgaria

Peking Union Medical College Hospital

Beijing, Beijing Municipality 100730

China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong 510080

China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi 530021

China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei 050031

China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hebei 430022

China

Henan Cancer Hospital

Zhengzhou, Henan 450004

China

The First Affiliated Hospital of Soochow University - Shizijie Campus

Suzhou, Jiangsu 215006

China

The First Affiliated Hospital of Nanchang University - Donghu Campus

Nanchang, Jiangxi 330006

China

Shengjing Hospital of China Medical University - Nanhu Campus

Shenyang, Liaoning 110004

China

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi 710068

China

Qilu Hospital of Shandong University

Jinan, Shandong 250012

China

Jinshan Hospital of Fudan University

Shanghai, Shanghai Municipality 201508

China

West China Hospital Sichuan University

Chengdu, Sichuan 610041

China

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

Tianjin, Tianjin Municipality 300020

China

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan 650101

China

Zhejiang Provincial Hospital of Chinese Medicine - Main

Hangzhou, Zhejiang 310006

China

Clinical Hospital Centar Zagreb

Zagreb, 10000

Croatia

Chu Dijon - Bourgogne

Dijon, Bourgogne-Franche-Comté 1000

France

Hospital Henri Mondor

Créteil, 94000

France

Olympion General Clinic & Rehabilitation Center

Pátrai, 264 43

Greece

General Hospital of Thessaloniki George Papanikolaou

Thessaloniki, 570 10

Greece

Queen Mary Hospital

Hong Kong, Pok Fu Lam

Hong Kong

Azienda Ospedaliera Universitaria Federico II

Naples, Campania 80131

Italy

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

Rome, Lazio oo610

Italy

Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

Catania, Sicily 95122

Italy

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Bologna, 40123

Italy

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

Milan, 20162

Italy

Fondazione IRCCS San Gerardo Dei Tintori

Monza, 20900

Italy

A.O.U. Maggiore della Carita

Novara, 28100

Italy

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, oo133

Italy

AOU Citta della Salute e della Scienza di Torino

Torino, 10126

Italy

Azienda sanitaria universitaria Giuliano Isontina

Trieste, 34129

Italy

Azienda ULSS 8 Berica - Ospedale San Bortolo

Vicenza, 36100

Italy

Chiba Aoba Municipal Hospital

Chuo-ku, Chiba 260-0852

Japan

Chibaken Saiseikai Narashino Hospital

Narashino-shi, Chiba 275-8580

Japan

National Hospital Organization Mito Medical Center

Ibaraki, Higashiibaraki-gun 311-3193

Japan

Yokohama City University Medical Center

Yokohama, Kanagawa 232-0024

Japan

Tohoku University Hospital

Sendai, Miyagi 980-8574

Japan

Kansai Medical University Hospital

Hirakata-shi, Osaka 573-1191

Japan

Hematology Ohta Clinic,Shinsaibashi

Osaka, Osaka 542-0081

Japan

Osaka University Hospital

Suita-shi, Osaka 565-0871

Japan

Saitama Medical University Hospital

Iruma-gun, Saitama 350-0495

Japan

The University of Tokyo Hospital

Bunkyo-ku, Tokyo 113-8655

Japan

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo 173-8610

Japan

Tokyo Metropolitan Bokutoh Hospital

Sumida-ku, Tokyo 130-0022

Japan

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi 400-8506

Japan

Erasmus Medical Center, Department of Hematology

Rotterdam, South Holland 3015 GD

Netherlands

Hagaziekenhuis

The Hague, South Holland 2545AA

Netherlands

Universitetet i Bergen

Bergen, 5021

Norway

IN-VIVO sp. z o.o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-048

Poland

Instytut Hematologii i Transfuzjologii Klinika Zaburzen Hemostazy i Chorob Wewnetrznych

Warsaw, Masovian Voivodeship 02-776

Poland

Pratia Onkologia Katowice - PRATIA

Katowice, Silesian Voivodeship 40-523

Poland

N. Copernicus Provincial MCOT in Lodz

Lodz, Łódź Voivodeship 93-513

Poland

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Kyungpook National University Hospital

Daegu, 41944

South Korea

Seoul National University Hospital (SNUH)

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Korea University Anam Hospital

Seoul, 2841

South Korea

Asan Medical Center

Seoul, 5505

South Korea

Hospital Universitario Fundacion Alcorcon

Alcorcón, Mardrid 28922

Spain

Hospital General Universitario Gregorio Maranon

Madrid, Mardrid 28007

Spain

Hospital Universitario 12 de Octubre

Madrid, Mardrid 28041

Spain

Hospital Universitario De Salaman

Salamanca, 37007

Spain

Hospital Universitario Virgen del Rocio

Seville, 41013

Spain

Karolinska Universitetssjukhuset

Huddinge, Stockholm County 14186

Sweden

Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology

Mamak, Ankara 6620

Turkey (Türkiye)

Aydin Adnan Menderes University Medical Faculty-Hematology Department

Efeler, Aydın 9100

Turkey (Türkiye)

Cerrahpasa Tip Fakultesi

Edirne, 22030

Turkey (Türkiye)

Trakya Universitesi Tip Fakultesi Hastanesi

Edirne, 22030

Turkey (Türkiye)

Sakarya University Education and Research Hospital

Sakarya, 54290

Turkey (Türkiye)

University Hospitals of Leicester NHS Trust

Leicester, East Midlands LE1 5WW

United Kingdom

Southampton General Hospital

Southampton, Hampshire SO16 6YD

United Kingdom

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

Southwark, London SE1 9RT

United Kingdom

Royal Liverpool and Broadgreen University Hospitals NHS Trust

Liverpool, Merseyside L7 8XP

United Kingdom

Greater Glasgow Health Board

Glasgow, Scotland G312ER

United Kingdom

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

Stoke-on-Trent, Staffordshire ST4 6QG

United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire LS9 TF

United Kingdom

Barts Health NHS Trust, Royal London Hospital

London, E11BB

United Kingdom

University College London Hospitals

London, NW1 2PG

United Kingdom

Imperial College Healthcare NHS Trust

London, W12 0HS

United Kingdom