Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
This study is testing a new medicine called ianalumab for adults newly diagnosed with Immune Thrombocytopenia (ITP). ITP is a condition where your body's immune system mistakenly attacks and destroys platelets, which are important for blood clotting. We want to find out if ianalumab, given alongside the usual first treatment (steroids), helps to keep your platelet count at a healthy level (30 G/L or more). Participants will be randomly assigned to receive either one of two doses of ianalumab or a dummy medicine (placebo), in addition to their steroid treatment. This is a Phase 3 study, meaning it's a large trial to confirm the medicine's effectiveness and safety, building on earlier research.
At a glance
What is this study about?
This research study is about a condition called Immune Thrombocytopenia, or ITP. If you have ITP, your body's immune system, which normally fights off germs, mistakenly attacks your own platelets. Platelets are tiny cells in your blood that help it to clot. When you don't have enough platelets, you might bleed or bruise easily. The usual first treatment for ITP is medicines called corticosteroids, often just called steroids.
In this study, we're looking at a new medicine called ianalumab. We want to see if adding ianalumab to your usual steroid treatment can help keep your platelet count at a safe level (30 G/L or more). A higher platelet count means your blood can clot better, reducing your risk of bleeding problems. The study will compare two different doses of ianalumab with a placebo, which is a dummy medicine that looks just like ianalumab but contains no active drug. This helps us to see if any positive effects are truly due to ianalumab and not just because you're receiving attention or expecting to get better.
This is a 'Phase 3' study, which means it's one of the final stages of testing a new medicine. It involves many people at different hospitals (multi-center) and is 'randomized,' meaning a computer will decide whether you get ianalumab or the placebo. It's also 'double-blind,' which means neither you nor your study doctor will know which treatment you are receiving. This is important to make sure the study results are fair and accurate. After the main treatment period, there will be a follow-up period to continue checking your health and how the treatment has worked.
Key takeaways
- This study is for adults newly diagnosed with Immune Thrombocytopenia (ITP).
- It tests a new medicine, ianalumab, alongside standard steroid treatment.
- Participants will receive either ianalumab or a dummy medicine (placebo).
- The aim is to see if ianalumab helps maintain healthy platelet counts.
- You'll receive close medical monitoring throughout the study.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. You must have been diagnosed with ITP within the last three months, and it must be your first time starting treatment for ITP, typically with steroids. Your platelet count must have been below 30 G/L before you started any ITP treatment, and it must also have improved to at least 50 G/L after you started steroids. You'll also need to sign a consent form to show you understand and agree to take part.
There are also some reasons why you might not be able to join. For example, if you have other serious blood conditions like Evans syndrome, or if you are currently experiencing very serious bleeding. If you have received certain ITP treatments before, apart from steroids or a medicine called IVIG, you might not be eligible. This includes treatments that affect certain immune cells (B-cells) or having had surgery to remove your spleen. You also can't take part if you have a very low count of other blood cells (neutrophils) or if you have other serious bleeding disorders or take blood-thinning medicines, unless it's a very low dose of aspirin.
The research team will review your medical history carefully to make sure the study is a safe and suitable option for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with ITP within the last 3 months?
- Is this your first time starting ITP treatment (usually steroids)?
- Was your platelet count below 30 before you started ITP treatment?
- Did your platelet count improve to at least 50 while on steroids?
- Do you have any other serious blood conditions or take regular blood thinners (other than low-dose aspirin)?
What does participation involve?
If you decide to join this study, you will go through a screening period to make sure you're a good fit. Once confirmed, you'll enter the main treatment period. You will receive either ianalumab or the placebo, along with your usual steroid medication. The study medicine will likely be given over a set period. You'll have regular appointments at the hospital or clinic for assessments, which will include blood tests to check your platelet count and overall health, and discussions with the study team about how you're feeling.
After the main treatment, everyone will move into a follow-up period. During this time, the study team will continue to monitor your health and how the treatment has affected you. This follow-up ensures your continued safety and helps the researchers understand the long-term effects of the study drug. The total time you'll be involved in the study will depend on how you respond to the treatment and the specific study schedule, which will be fully explained to you.
Potential risks and benefits
Locations (114)
- Yuma Regional Medical CenterVerified postcodeYuma, United States
- Community Cancer InstituteVerified postcodeClovis, United States
- Compassionate Care Res Group IncVerified postcodeFountain Valley, United States
- University of Colorado AnschutzVerified postcodeAurora, United States
- DH Cancer Research Center LLCVerified postcodeMargate, United States
- Uni of Chi Medi Ctr Hema and OncoVerified postcodeChicago, United States
- Parkview Research CenterVerified postcodeFort Wayne, United States
- Oncology Care AssociatesVerified postcodeBethesda, United States
- Massachusetts General HospitalVerified postcodeBoston, United States
- Beth Israel Deaconess Med CenterVerified postcodeBoston, United States
- Michigan Center of Medical ResearchVerified postcodeFarmington Hills, United States
- Mayo Clinic RochesterVerified postcodeRochester, United States
Common questions
What is ITP?
ITP stands for Immune Thrombocytopenia. It's a blood condition where your body's immune system mistakenly attacks and destroys your platelets, which are needed for blood clotting.
What is ianalumab?
Ianalumab is a new medicine being tested in this study. We want to see if it can help adults with ITP keep their platelet counts at a healthy level when given with steroids.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real study drug but contains no active ingredients. It helps researchers fairly compare how well the new medicine works.
Will I know if I'm getting the active medicine or the placebo?
No, neither you nor your study doctor will know whether you are receiving ianalumab or the placebo. This is called 'double-blind' and ensures the study results are unbiased.
How long will I be in the study?
The total time in the study will involve a treatment period and a follow-up period. The exact duration will be explained by the study team, as it can vary depending on your response to treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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