Argenx ITP - Clinical Trial
What is the Purpose of this Study?
If you join this study, you will be randomly placed into one of two groups. One group will get the study medicine called efgartigimod, and the other group will get a placebo, which is a fake medicine. Both are given through a tube in your vein, called an IV.
You will get the medicine or placebo for the first 4 weeks. After that, depending on your platelet count, you will keep getting it every week or every other week for 20 more weeks. After 24 weeks, you may be able to join the next part of the study, where everyone gets the real medicine for up to 52 weeks. If the medicine does not work well enough after 12 weeks, you might be able to switch to the real medicine earlier.
Primary Immune Thrombocytopenia (ITP)
Who Can Participate in the Study?
To join this study, people must:
- Have been diagnosed with a blood condition called primary ITP more than a year ago.
- Have tried medicine for ITP before, but it did not work well.
- Have a platelet count higher than 30 billion per liter of blood.
- Not have had cancer in the last 3 years.
- Not have had a blood clot in the last 12 months.
What is Involved?
This study is testing a new medicine called efgartigimod to see if it is safe and works well for people with a blood condition called primary immune thrombocytopenia, or ITP. These are people who tried other treatments but did not get better.
In the study, people will be randomly placed into one of two groups. One group will get the real medicine, and the other group will get a placebo, which is a fake medicine. Both are given through a tube in the arm called an IV.
For the first 4 weeks, everyone gets either the medicine or the placebo. After that, depending on their blood test results, they will keep getting it every week or every other week for 20 more weeks. After 24 weeks, people can join the next part of the study where everyone gets the real medicine for up to 52 weeks. If someone does not get better after 12 weeks, they may be able to switch to the real medicine sooner.