TAK-079-3002 (Chronic Primary Immune Thrombocytopenia) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called mezagitamab (the study drug) is a safe and effective option for people with chronic primary immune thrombocytopenia (ITP). We want to know if adding the study drug to someone's current treatment has any benefit.
Chronic Primary Immune Thrombocytopenia (ITP)
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with chronic primary immune thrombocytopenia
- Were diagnosed at least 12 months ago
- Have evidence of insufficient response or intolerance to at least 1 currently available first-line therapy for ITP
For more information, contact the study team at kristin.byrne@duke.edu.
What is Involved?
If you choose to join this study, you will get a random assignment (by chance) to either take the study drug or a placebo (inactive substance with no drug in it). You will have a 2-in-3 chance of getting the study drug. Both the study drug and placebo are given as a subcutaneous injection (shots under the skin).
You will get a dose of the study drug and placebo once per week for 2 8-week periods of time. Between these two dosing periods, you will take an 8-week break and not get any doses of the study drug/placebo.
At the end of the study, you may have the option to continue participating in an extension study.