RecruitingPHASE2INTERVENTIONAL

Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders

This study is testing a new medicine, tafasitamab, for adults who have a specific autoimmune blood condition called Immune Thrombocytopenia (ITP). In ITP, your body's immune system mistakenly attacks and destroys your platelets, which are essential for blood clotting. The main goal is to check how safe tafasitamab is and how well it helps control ITP. This research is for people who have already tried other common treatments like steroids or rituximab, but their condition either didn't get better enough or came back. By participating, you could help doctors learn if tafasitamab might offer a new way to manage ITP, potentially improving the lives of many patients in the future.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Incyte Corporation

Enrolment target

Start

29 Dec 2025

Estimated completion

09 Mar 2028

Immune Thrombocytopenia

What is this study about?

This study is like a careful investigation into a new medicine called tafasitamab. It's designed for people in the UK who have a specific health problem called Immune Thrombocytopenia (ITP). With ITP, your body's defence system, called the immune system, gets confused and starts attacking important blood cells called platelets. Platelets help your blood to clot, so when you don't have enough of them, you can bruise easily or have bleeding problems. Researchers want to find out if tafasitamab is a safe and effective treatment that could help manage ITP.

The main idea behind this study is to see if tafasitamab can help improve platelet counts in people whose ITP hasn't responded well to other common treatments, or if it has come back after getting better for a while. You might have already tried medicines like steroids or another treatment called rituximab. This study is trying to find new options for people who are still struggling with their ITP, aiming to offer a different way to help their bodies stop attacking their own platelets.

By taking part, you would be helping doctors and scientists learn more about ITP and how best to treat it. The information gathered from this study could lead to new and better treatments for many people living with ITP in the future. It's an important step towards improving care and potentially offering new hope.

Key takeaways

This study is testing a new medicine, tafasitamab, for adults with ITP.
It's for people whose ITP hasn't responded well to previous treatments or has come back.
The main goals are to check the medicine's safety and how well it works.
Your participation could help find new ways to treat ITP for others.
You'll have regular check-ups and blood tests during the study.
You can leave the study at any time if you change your mind.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with Immune Thrombocytopenia (ITP). You will need to have a clear diagnosis of this condition.

It's important that you have previously responded at least temporarily to earlier treatments for your ITP, such as steroids or rituximab, even if your condition later got worse again. You also shouldn't have had your spleen removed. Your platelet count needs to be quite low when you join the study, showing that your ITP is currently active and needs treatment.

You'll also need to be able to understand the study and agree to take part by signing a consent form. The research team will go through everything with you in detail to make sure this study is right for your specific situation.

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 Immune Thrombocytopenia (ITP)?
Have you tried other treatments for your ITP (like steroids or rituximab) that worked for a while, even if your ITP came back?
Is your ITP currently active, meaning your platelet count is low?
Have you *not* had your spleen surgically removed?
Are you able to understand and sign a consent form to join the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study medication, tafasitamab. The research team will explain how often and for how long you'll receive it. You'll have regular hospital visits for check-ups, which will include blood tests to monitor your platelet count and overall health, and to see how you're reacting to the treatment. These visits are important for the team to keep a close eye on your progress and any effects of the medicine.

Throughout the study, you'll be in close contact with the study team, who will be there to answer your questions and support you. They will explain the full schedule of visits and tests during the consent process. The total amount of time you’ll be involved in the study will be explained to you, including the treatment period and any follow-up appointments.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A possible benefit of joining this study is that tafasitamab might help improve your platelet count and manage your ITP more effectively, especially if other treatments haven't worked well for you. It could also help develop new medicines for others in the future. However, there's no guarantee that the treatment will work for everyone, and like all medicines, tafasitamab may cause side effects. These will be discussed with you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (40)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Palo Verde Cancer Specialists Palo Verde Hematology Oncology, Ltd Glendale
Verified postcode
Glendale, United States· Recruiting
Usc Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States· Recruiting
Rocky Mountain Cancer Centers
Verified postcode
Lone Tree, United States· Not yet recruiting
Yale University School of Medicine
Verified postcode
New Haven, United States· Not yet recruiting
Gnp Research
Verified postcode
Cooper City, United States· Recruiting
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States· Recruiting
Montefiore Medical Center
Verified postcode
The Bronx, United States· Recruiting
Inova Schar Cancer Institute
Verified postcode
Fairfax, United States· Not yet recruiting
Fred Hutchinson Cancer Center
Verified postcode
Seattle, United States· Not yet recruiting
Versiti Bloodcenter of Wisconsin Bcw Milwaukee
Verified postcode
Milwaukee, United States· Not yet recruiting
St Vincent'S Hospital Sydney
Verified postcode
Darlinghurst, Australia· Recruiting
Townsville University Hospital
Verified postcode
Douglas, Australia· Recruiting

Common questions

What is Immune Thrombocytopenia (ITP)?

ITP is a condition where your body's immune system mistakenly attacks and destroys your platelets, which are essential for blood clotting and stopping bleeding.

What is tafasitamab?

Tafasitamab is an investigational new medicine being tested in this study to see if it can help treat ITP by affecting the immune system.

Will I stop my current ITP medication if I join?

The study team will discuss all your current medications with you and explain how they might be adjusted or if you would need to stop any for the study.

How long will the study last if I take part?

The team will tell you the exact length of your involvement, which includes the time you receive treatment and any follow-up appointments.

Do I have to pay to be in the study?

No, you will not have to pay to participate in the study, and any study-related treatments and tests will be provided at no cost to you.

How to find out more

Incyte Corporation Call Center (US)

medinfo@incyte.com 1.855.463.3463 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.