A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Recruiting now · Phase 3

Conditions studied: Immune Thrombocytopenic Purpura (ITP)

In brief

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 lower number of platelets, making it easier to bruise or bleed. The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time. Participants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met. During the study, participants will visit their study clinic several times.

Key facts

Study ID

NCT06948318

Run by

Takeda

People needed

150

Starts

2025-08-14

Expected to finish

2029-07-29

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• The Second Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (enrolling)
• Medical Center "Fama Medical" — Plovdiv, Bulgaria (enrolling)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hebei, China (enrolling)
• Jinshan Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS — Tianjin, Tianjin Municipality, China (enrolling)
• The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
• Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia — Sofia, Sofia-Grad, Bulgaria (enrolling)
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• The First Affiliated Hospital of Nanchang University - Donghu Campus — Nanchang, Jiangxi, China (enrolling)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)
• West China Hospital Sichuan University — Chengdu, Sichuan, China (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• Westmead Hospital — Westmead, New South Wales, Australia (enrolling)
• Monash University - Australian Centre for Blood Diseases (ACBD) — Melbourne, Victoria, Australia (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Perth Blood Institute — West Perth, Western Australia, Australia (enrolling)
• UMHAT Sv. Ivan Rilski — Sofia, Bulgaria (enrolling)
• UMHAT SofiaMed, OOD — Sofia, Bulgaria (enrolling)
• Canberra Hospital — Garran, Australian Capital Territory, Australia (enrolling)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (enrolling)
• St George Hospital — Kogarah, New South Wales, Australia (enrolling)
• University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre — Liverpool, New South Wales, Australia (enrolling)
• General Hospital of Thessaloniki George Papanikolaou — Thessaloniki, Greece (enrolling)

Full record on ClinicalTrials.gov

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