INCB 39110-801 A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110)
This study is designed for adults who have previously been involved in research looking at a medicine called Itacitinib. It allows these patients to continue receiving the drug for various health conditions, including myelofibrosis (a bone marrow disorder), chronic graft-versus-host disease (a complication after stem cell transplants), or breathing problems after a lung transplant. The main goal is to keep a close eye on anyone taking Itacitinib for any side effects or other changes, making sure the treatment remains safe and appropriate. It's an important step for those already benefiting from the drug to keep access and for doctors to learn more about its long-term use.
At a glance
What is this study about?
This study is for people who have already been taking part in a previous research study for a medicine called Itacitinib. Think of it like this: if you were in a trial testing a new car and liked it, this study lets you keep driving it while the manufacturers continue to check how it's working for you.
The main purpose of this study is to let people continue receiving Itacitinib. This medicine is being looked at for conditions like myelofibrosis, which is a condition where your bone marrow doesn't work as it should. It's also for a problem called chronic graft-versus-host disease, which can happen after a stem cell transplant, and certain breathing problems in people who have had a lung transplant. By keeping people on the medicine, doctors can continue to gather important information about its long-term effects and safety.
Because you've already been part of a study, you and your doctors will already know a lot about Itacitinib. This new study is mostly about making sure you can keep getting the medicine if it's helping you, and to carefully watch for any side effects or concerns that might come up over a longer period.
Key takeaways
- This study is for adults who previously took Itacitinib in another research trial.
- It allows continued access to Itacitinib for conditions like myelofibrosis or chronic graft-versus-host disease.
- The main focus is to continue monitoring for any side effects and ensure safe, ongoing treatment.
- Participants will have regular medical check-ups and discussions with the study team.
- Joining is voluntary, and you can leave the study whenever you wish.
Who may be eligible?
To join this study, you must be 18 years old or older. There is no upper age limit, meaning older adults are welcome to participate. Both men and women can take part in this research.
The most important requirement is that you must have previously participated in an earlier study looking at the medicine Itacitinib. This study is specifically for those who were already receiving Itacitinib and need to continue their treatment because they have conditions like myelofibrosis, chronic graft-versus-host disease, or certain issues after a lung transplant.
Basically, if you're an adult who has been taking Itacitinib in a previous trial for one of these conditions and doctors think it's still beneficial for you, this study might be an option to continue access to the medication.
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 previously been enrolled in a study for Itacitinib?
- Are you currently being treated for myelofibrosis, chronic graft-versus-host disease, or breathing problems after a lung transplant?
- Are you able and willing to attend regular clinic visits?
- Have you discussed this study with your current doctor?
What does participation involve?
If you decide to join this study, you will continue to receive the medicine Itacitinib, which you've already been taking. Because you've been in a previous study, many of the procedures will likely feel familiar. You'll have regular visits to your clinic or hospital where the study team will monitor your health. These visits will involve checks like blood tests, physical examinations, and discussions about how you're feeling and any side effects you might be experiencing.
The study team will carefully track any side effects or health changes you report. The duration of your participation will depend on how you respond to the treatment and your individual health needs. The aim is to allow you to continue receiving Itacitinib for as long as it's appropriate and safe for you, under close medical supervision.
Potential risks and benefits
Locations (6)
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- —UnverifiedGreece
Common questions
What is Itacitinib?
Itacitinib is a medicine being studied for conditions like myelofibrosis and chronic graft-versus-host disease. You would have been taking it in a previous study.
Why is this study happening?
This study allows people who were already taking Itacitinib in an earlier study to continue receiving the medicine and for doctors to monitor their health over a longer period.
Who can join this study?
Adults (18 and over) who have previously taken part in an Itacitinib study for conditions like myelofibrosis, chronic graft-versus-host disease, or post-lung transplant issues.
What do I have to do if I join?
You will continue taking Itacitinib and attend regular clinic visits for health checks and to report any side effects.
Can I stop participating at any time?
Yes, you are free to withdraw from the study at any point, and your usual medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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