A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Clinicaltrials.gov

#NCT06722235

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EU CTIS

#2024-514401-54-00

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jRCT

#jRCT2031240667

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).

CN

JP

Interventional Phase 3 clinical trial.

What medical conditions are being studied?

Immune Thrombocytopenic Purpura (ITP)

What is the clinical trial testing?

Placebo, Mezagitamab

How many participants are being enrolled?

171

Are placebos part of the clinical trial?

No

When is the clinical trial being conducted?

Feb 2025 - Dec 2027

How long is participation in the clinical trial?

Participants can be in this study for up to 7 months.

Sexes

All

Age

18+ Years

Healthy volunteers?

No

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

Must have primary immune thrombocytopenia (ITP) for at least 12 months before participating in the study.

Must have previously had at least 2 standard treatments for their condition that did not work or the participant did not tolerate.

Cannot have secondary ITP.

Cannot have had problems with blood clotting, with blood clots blocking the flow of the blood (thrombotic or embolic events) within 12 months before participating in the study.

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

Cannot have serious lung conditions.

Cannot have been vaccinated within 1 month before participating in the study

Additional entry criteria will be discussed with the study doctor.