A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
This research study is investigating a new medication called XTMAB-16 for people who have pulmonary sarcoidosis, a condition that affects the lungs. It's a combined Phase 1b/2 trial, which means it's an early look at the new drug. Researchers want to see how safe XTMAB-16 is and if it has any positive effects on the participants' sarcoidosis, compared to a placebo (a dummy medicine with no active ingredients). This type of study helps scientists understand if the new treatment is promising enough to be tested in larger groups of people in the future. The trial involves people aged 18 to 80 who have been diagnosed with pulmonary sarcoidosis.
At a glance
What is this study about?
This study is exploring a new treatment, XTMAB-16, for a lung condition called pulmonary sarcoidosis. Sarcoidosis causes tiny clumps of cells, called granulomas, to grow in different parts of the body, most often the lungs. This can lead to symptoms like breathlessness and a cough. Currently, treatments often involve steroids and other medicines to reduce inflammation and stop the sarcoidosis from getting worse.
Researchers are always looking for better and more effective ways to manage conditions like sarcoidosis. This particular study is in its early stages (Phase 1b/2), which means it's one of the first times this new medicine, XTMAB-16, is being tested in a small group of people with the condition. The main goals are to check if XTMAB-16 is safe and how well people can tolerate it. They also want to see if there are any early signs that it might help improve the symptoms or the condition itself.
By comparing XTMAB-16 to a placebo (a treatment that looks the same but contains no active drug), the researchers can get a clearer idea of whether any changes seen are due to the new medicine or other factors. This careful process is a vital step in developing new treatments that could one day help more people living with pulmonary sarcoidosis.
Key takeaways
- This study is testing a new medicine, XTMAB-16, for pulmonary sarcoidosis.
- It's an early-stage study (Phase 1b/2) to check safety and initial effectiveness.
- Participants will receive either XTMAB-16 or a placebo (dummy medicine).
- You must have a diagnosed sarcoidosis and meet specific health criteria to join.
- Participation involves regular clinic visits for tests and monitoring.
- You can leave the study at any time without affecting your ongoing care.
Who may be eligible?
To join this study, you generally need to be an adult between 18 and 80 years old, and you must have been diagnosed with pulmonary sarcoidosis for at least six months. Your doctor will need to confirm your diagnosis meets specific guidelines. You'll also need to be experiencing some level of breathlessness and be currently taking certain medications for your sarcoidosis, like specific doses of prednisone or other immune-suppressing drugs, and have been on a stable dose for a set period.
There are also some reasons why you might not be able to take part. For example, if you are pregnant, breastfeeding, or planning to become pregnant, you won't be able to join. Very specific health conditions or being over 65 (for some parts of the study in the EU) could also prevent your participation. The study also requires a negative COVID-19 test result to ensure everyone's safety.
Before you can join, the study team will carefully check all these points to make sure the study is right for you and that you meet all the necessary requirements for your safety and to get reliable results.
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 between 18 and 80 years old?
- Have you been diagnosed with pulmonary sarcoidosis for at least six months?
- Are you currently taking specific sarcoidosis medications (like prednisone) at a stable dose?
- Are you able to attend regular clinic appointments for the study?
- Are you not pregnant, breastfeeding, or planning to become pregnant?
What does participation involve?
If you decide to take part in this study, you would be given either the new medicine, XTMAB-16, or a placebo (a dummy medicine) through an injection or infusion, though the detailed method isn't specified here. Neither you nor your study doctor would know which one you are receiving. You would need to attend regular visits at the study clinic for assessments, which typically include physical exams, blood tests, breathing tests, and questionnaires to check your health and how you están feeling. The team will monitor how you respond to the treatment and any side effects you might experience.
You would need to follow specific instructions carefully, such as avoiding grapefruit or certain citrus fruits during the study. Throughout the study, you'd continue taking your usual sarcoidosis medications at stable doses, as guided by the study doctors. We don't have the exact duration of the study or how many visits are needed, but clinical trials usually involve several months of active treatment and follow-up appointments.
Potential risks and benefits
Locations (34)
- Xentria Investigative SiteVerified postcodeBirmingham, United States· Recruiting
- Xentria Investigative SiteVerified postcodeDenver, United States· Recruiting
- Xentria Investigative SiteVerified postcodeJacksonville, United States· Completed
- Xentria Investigative SiteVerified postcodeChicago, United States· Recruiting
- Xentria Investigative SiteVerified postcodeChicago, United States· Recruiting
- Xentria Investigative SiteVerified postcodeIowa City, United States· Recruiting
- Xentria Investigative SiteVerified postcodeBaltimore, United States· Recruiting
- Xentria Investigative SiteVerified postcodeDetroit, United States· Recruiting
- Xentria Investigative SiteVerified postcodeMinneapolis, United States· Recruiting
- Xentria Investigative SiteVerified postcodeAlbany, United States· Terminated
- Xentria Investigative SiteVerified postcodeNew York, United States· Recruiting
- Xentria Investigative SiteVerified postcodeGreenville, United States· Recruiting
Common questions
What is pulmonary sarcoidosis?
Pulmonary sarcoidosis is a condition where tiny clumps of cells, called granulomas, grow in your lungs. This can cause symptoms like breathlessness and cough.
What is XTMAB-16?
XTMAB-16 is a new medicine being tested for pulmonary sarcoidosis. It's currently in early stages of research to see if it's safe and effective.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real treatment but contains no active drug. It helps researchers see if the new medicine truly has an effect.
Will I know if I'm getting the new medicine or the placebo?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving XTMAB-16 or the placebo.
Can I stop participating in the study at any time?
Yes, you can choose to leave the study at any point, for any reason, without it affecting your regular medical care.
How to find out more
Xentria, Inc.
Always speak to your GP or specialist before deciding to take part in a study.
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