A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms.
This Phase 1 clinical trial is studying a new drug named INCB160058 in adults who have myeloproliferative neoplasms (MPNs). MPNs are a group of rare, long-term blood conditions where the bone marrow makes too many blood cells. Because this is a Phase 1 study, it is one of the first times this medicine is being tested in people. Researchers want to check how safe INCB160058 is, observe any side effects it might cause, and see how it moves through the human body. They also want to find the safest and most effective dose to test in larger, future trials. The trial is 'open-label', meaning both you and the study doctors will know you are taking the study drug. Taking part involves regular hospital visits, health checks, and blood tests so doctors can carefully monitor your wellbeing throughout the study.
At a glance
What is this study about?
Myeloproliferative neoplasms, often shortened to MPNs, are an uncommon group of conditions that affect your bone marrow—the soft, spongy centre of your bones where blood cells are made. In people with MPNs, the bone marrow produces too many red blood cells, white blood cells, or platelets. Over time, having too many blood cells can make the blood thicker and cause symptoms like extreme tiredness, itching, headaches, or an increased risk of blood clots.
While there are treatments available today that help manage MPN symptoms, doctors are always looking for better, more targeted options. This clinical trial is testing an experimental medicine known as INCB160058. Researchers hope this drug might help control the overproduction of blood cells by targeting the specific pathways that cause MPNs to develop.
Because this is an early Phase 1 trial, the main goal is not yet to prove that the drug cures the condition. Instead, doctors need to check its safety, see what side effects it might bring, and work out the most suitable dose for patients. By taking part, participants help scientists gather the vital information needed to decide whether this drug could become a helpful new treatment in the future.
Key takeaways
- This is an early-stage (Phase 1) trial testing a new drug called INCB160058.
- The trial is for adults aged 18 and older diagnosed with a myeloproliferative neoplasm (MPN).
- The main goals are to check safety, monitor side effects, and find the right dose.
- The study is open-label, meaning there is no placebo and everyone receives the study drug.
- Taking part is voluntary, and you can withdraw at any time without losing your regular care.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with a myeloproliferative neoplasm (MPN). Both men and women can take part. Because it is an early-stage safety study, doctors will look very closely at your overall health before confirming if the trial is right for you.
To join, your major organs—such as your heart, kidneys, and liver—will need to be working reasonably well. You will also need to be well enough to attend regular hospital appointments and complete all required tests.
You may not be able to join if you have certain other serious medical conditions, an active severe infection, or if you are pregnant or breastfeeding. The trial team will also review any other medicines you take to make sure they do not interfere with the study drug.
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.
- I am aged 18 or older.
- I have been diagnosed with a myeloproliferative neoplasm (MPN).
- I am able to attend regular clinic visits for tests and monitoring.
- I am not currently pregnant or breastfeeding.
- I am open to trying an experimental medicine under close medical supervision.
What does participation involve?
If you decide to take part, you will first attend a screening visit to check your general health and confirm that the trial is safe for you. This will include blood tests, physical checks, and a review of your medical history.
Once enrolled, you will be given the study medicine, INCB160058. Because this is an open-label study, you and your medical team will know the exact dose you are receiving. You will need to visit the hospital or clinic regularly. During these visits, doctors will check your blood counts, monitor your vital signs, perform heart tests (like an ECG), and ask how you are feeling.
These frequent visits allow the team to closely watch for any side effects and see how the medicine behaves in your system. The trial team will tell you the exact length of time you will be in the study, and you will have follow-up checks after you stop taking the drug to make sure you stay safe and well.
Potential risks and benefits
Locations (4)
- —UnverifiedNorway
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedItaly
Common questions
What does a Phase 1 trial mean?
A Phase 1 trial is one of the earliest stages of testing a new medicine in people. Its main goal is to find out if the drug is safe, what side effects it has, and what the best dose is.
What does 'open-label' mean?
Open-label means that everyone involved—including you, your nurses, and your doctors—knows you are receiving the experimental drug. There is no dummy pill (placebo) used in this study.
Will taking part cure my condition?
No, this trial is designed to test safety and dosing rather than to cure the disease. While doctors hope the drug will help, there is no guarantee it will improve your symptoms.
Will I have to pay to take part?
No, you do not pay for trial treatments in the UK. The study medicine and all related tests are provided free of charge, and some trials also help cover travel expenses.
Can I leave the trial if I change my mind?
Yes, taking part is entirely your choice. You are free to stop and leave the trial at any point, and doing so will never affect your usual NHS care or your relationship with your doctors.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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