A Long-term Multicenter Open-label Study to Evaluate the Long-term Safety and Durability of Effect of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extra pulmonary Involvement
This study is testing a new medicine called XTMAB-16 for people who have pulmonary sarcoidosis. This is a condition where tiny clumps of cells, called granulomas, grow in your lungs and sometimes in other parts of your body. The main goal of this study is to check how safe the medicine is over a long period. Researchers will be looking out for any side effects. They also want to see if the medicine keeps working to help manage sarcoidosis symptoms. This is a "Phase II" study, which means it builds on earlier research and aims to understand more about the medicine's effects and safety in a larger group of people.
At a glance
What is this study about?
This study is investigating a new medicine called XTMAB-16 for people who have pulmonary sarcoidosis. This is a condition where tiny clumps of inflammatory cells, called granulomas, can form in different organs of your body, most commonly the lungs. Sometimes, these clumps can also appear in other places like your skin, eyes, or liver.
The main purpose of this study is to see how safe the new medicine, XTMAB-16, is when taken for a long time. Researchers will keep a close eye on participants for any side effects, whether they are minor or more serious. They also want to understand if the medicine continues to help people with their sarcoidosis symptoms over time. Think of it as a long-term check-up for the new medicine’s safety and effectiveness.
Researchers will also be looking at several other things. For example, they'll check if the medicine helps reduce the amount of steroid medication people need to take, as steroids can have their own side effects. They'll also monitor participants' quality of life, using special surveys about lung health, general well-being, cough, and how steroids affect them. Lung function tests will be done to see if the medicine helps improve breathing. They will also collect blood samples to look at certain markers that might give clues about the body’s response to the treatment.
Key takeaways
- This study evaluates a new medicine, XTMAB-16, for lung sarcoidosis.
- The main focus is on long-term safety and how well the medicine continues to work.
- It's a long-term study for adults aged 18 and over.
- You'll have regular check-ups, blood tests, and lung function assessments.
- You might reduce your need for steroid medications.
- You can leave the study at any time.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
You should have been diagnosed with pulmonary sarcoidosis. This means your sarcoidosis affects your lungs. It's okay if your sarcoidosis also affects other parts of your body, but having lung involvement is a key requirement.
The research team will have a more detailed list of criteria to make sure the study medicine is safe for you and that the results are as clear as possible. They will carefully check your medical history to see if you are a good fit for the study.
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?
- Do you have sarcoidosis that affects your lungs?
- Are you able to attend regular clinic visits?
- Are you willing to take the study medicine as directed?
What does participation involve?
If you decide to take part in this study, you will receive the study medicine, XTMAB-16. This is an "open-label" study, which means both you and the study doctors will know you are receiving XTMAB-16.
Throughout the study, you will have regular visits to the clinic. During these visits, the medical team will carefully monitor your health. They will check for any side effects by asking you questions and doing physical examinations. You will also have blood tests to see how your body is reacting to the medicine and to measure certain markers related to sarcoidosis and the study drug. Lung function tests will also be performed to assess your breathing. You'll also be asked to complete questionnaires about your quality of life, your cough, and any effects from steroids you might be taking. The study will last for a long time, but the exact duration will be explained by the study team.
Potential risks and benefits
Locations (5)
- —UnverifiedCzechia
- —UnverifiedDenmark
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedItaly
Common questions
What is pulmonary sarcoidosis?
It's a condition where tiny clumps of cells, called granulomas, grow in your lungs and sometimes other parts of your body.
What is XTMAB-16?
It's the new medicine being tested in this study for sarcoidosis.
What does 'open-label' mean?
It means both you and the study doctors will know that you are receiving the study medicine, XTMAB-16.
Will I still take my regular medicines?
The study doctors will discuss all your current medicines with you to see what is allowed or needs to change during the study.
Do I have to pay to join the study?
No, you will not have to pay for the study medicine or study-related tests.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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