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A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Sponsored by Takeda

About this trial

Last updated a month ago

Study ID

TAK-079-3002

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started a year ago

What is this trial about?

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).

What are the participation requirements?

Yes

Inclusion Criteria

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.
No

Exclusion Criteria

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.

Locations

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Withdrawn
Withdrawn

For more information, view the full study details:

NCT06722235jRCT2031240667