Overview

“A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Adults With Previously Untreated Primary Immune Thrombocytopenia (ITP)”

This study is looking at a new way to treat adults who have recently been diagnosed with a condition called immune thrombocytopenia (ITP). In ITP, the body attacks its own platelets, which are cells that help stop bleeding. Low platelet levels can increase the risk of bruising and bleeding and may affect daily life. The usual first treatment for ITP is a short course of steroid medication (such as prednisone), but many people do not have a long-lasting response, and the condition can return. This study is testing whether adding another approved medication, called romiplostim, to standard steroid treatment can help increase platelet counts more effectively and keep them stable for longer. About 126 adults will take part in this study. Participants will be randomly assigned (like flipping a coin) to one of two groups:

One group will receive romiplostim plus standard steroid treatment The other group will receive standard steroid treatment alone

Romiplostim works in a different way than steroids. While steroids reduce the immune system’s attack on platelets, romiplostim helps the body make more platelets. Using both together may provide a stronger and more lasting effect. Participants will be followed for about one year. During the study, they will:

- Receive treatment and regular checkups - Have blood tests to monitor platelet levels - Be monitored for any side effects - Report their symptoms and quality of life

The main goal of the study is to see if more people taking romiplostim plus steroids achieve a stable increase in platelet counts compared with steroids alone. Researchers will also look at how long it takes before additional treatment is needed, how much steroid medication is required, and how the treatments affect quality of life. The results of this study may help improve treatment options for people newly diagnosed with ITP in the future.