This study involves people with Chronic Primary Immune Thrombocytopenia, a condition where the body’s defense system mistakenly attacks and destroys blood cells called platelets that help blood to clot. When platelet counts are too low, there is an increased risk of bleeding and bruising. The treatment being studied is called Mezagitamab, which is also known by its code name TAK-079, and is given as an injection under the skin using a solution for injection. This medicine is designed to help increase platelet counts in people with this condition.
The purpose of this study is to evaluate the long-term safety and how well mezagitamab works in adults who have already participated in previous studies with this medicine and completed those studies. The study will look at whether the treatment causes any unwanted effects over a longer period of time and whether it continues to help maintain platelet counts at safe levels. The study will also examine how long the positive effects on platelet counts last, whether people need fewer other medicines for their condition, and whether they need less emergency treatment for low platelet counts.
During the study, participants will receive mezagitamab through subcutaneous injection, which means the medicine is injected into the tissue just under the skin. The treatment can continue for up to 104 weeks. Throughout the study, doctors will monitor participants for any side effects and measure how the body responds to the treatment by checking platelet counts and other blood tests. The study will also check how the medicine moves through the body and whether the body develops any reaction against the medicine over time.
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