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+ Years
All
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?
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.
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.
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