A Continuation Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Clinicaltrials.gov

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EU CTIS

#2025-521692-31-00

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.

Interventional Phase 3 clinical trial.

What medical conditions are being studied?

Immune Thrombocytopenic Purpura (ITP)

What is the clinical trial testing?

Mezagitamab

How many participants are being enrolled?

150

Are placebos part of the clinical trial?

No

When is the clinical trial being conducted?

Aug 2025 - Jul 2029

How long is participation in the clinical trial?

Participants from the TAK-079-3002 can be in this study for up to almost 2 years (88 weeks) and participants from TAK-079-1004 can be in this study for a bit over 2 years (108 weeks).

Sexes

All

Age

18+ Years

Healthy volunteers?

No

Men and women of 18 years or older can participate in this study.

Must have participated in and fully completed either the TAK-079-1004 or the TAK-079-3002 study

Cannot have had any medical problems deemed due to study treatment which either lead to the stopping of treatment or required a stay at the hospital (in case of an infection) during the TAK-079-3002 or TAK-079-1004 studies

Cannot have had a blood clotting event within 1 year before starting in this continuation study. This includes both a blood clot blocking the flow of blood (called thrombotic event) or a blood clot travelling through the blood stream and blocking a smaller blood vessel somewhere else in the body (called embolic event).

Cannot have had the spleen removed (splenectomy) within 3 months before participating in the study

Cannot have certain infections as defined in the study plan

Cannot have had certain types of cancer within 5 years of starting study participation

Cannot have serious lung problems

Cannot have received treatment against blood clotting (called anticoagulants) within 3 weeks before study start

Additional entry criteria will be discussed with the study doctor.