A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis
This study is investigating a new medication, Namilumab, for individuals living with chronic pulmonary sarcoidosis, a long-term lung condition. The main goal is to find out if Namilumab can help prevent or reduce significant problems or 'rescue events' related to the condition. We also want to understand how safe the medicine is and if people can tolerate it well. During the study, some participants will receive Namilumab, while others will get a placebo (a dummy medicine with no active ingredients). This helps us compare the effects fairly. We'll also be looking at how people's breathing changes, how quickly they might need extra treatment, and if they can reduce their steroid medication. This research aims to explore if Namilumab could be a helpful new treatment option.
At a glance
What is this study about?
This study is a research project focusing on chronic pulmonary sarcoidosis, a condition that causes tiny clumps of cells to grow in the lungs, making it harder to breathe and sometimes leading to other symptoms. We're looking at a new medicine called Namilumab to see if it can help people who have this long-term lung condition.
The main aim of this study is to find out if Namilumab can reduce the number of times people experience a 'rescue event.' A rescue event means an unexpected worsening of your sarcoidosis that requires additional urgent treatment. We want to see if this new medicine can help prevent these events from happening as often. We'll also be carefully checking if Namilumab is safe to use and if people can take it without too many side effects.
To make sure our findings are reliable, some participants will receive Namilumab, while others will receive a placebo – which looks exactly like the study medicine but contains no active ingredients. This helps scientists compare the effects of the new medicine fairly. We'll also be tracking other important changes, like how people's breathing is doing, if they can reduce their steroid medications, and how their overall health feels.
Key takeaways
- This study is for adults with long-term lung sarcoidosis.
- It's testing a new medicine called Namilumab against a dummy medicine (placebo).
- The main goal is to see if Namilumab reduces flare-ups and is safe.
- Participation involves regular clinic visits for health checks and tests.
- You won't know if you're getting the active medicine or the placebo during the main study phase.
Who may be eligible?
To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults are welcome to participate if they meet all other requirements.
This study is open to both men and women. The researchers are looking for people specifically diagnosed with chronic pulmonary sarcoidosis that affects their lungs. This means that your lung condition must be ongoing and not a new or short-term issue.
The research team will review your medical history and conduct some tests to make sure the study is right for you and that you meet all the specific health criteria for participating safely.
- Are you 18 years old or older?
- Do you have a diagnosis of chronic pulmonary sarcoidosis?
- Is your sarcoidosis mainly affecting your lungs?
- Are you able to attend regular clinic appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be involved in the study for a period of time, which includes regular visits to a clinic. During these visits, the study team will carry out health checks, such as measuring your vital signs (like blood pressure and heart rate), taking blood samples, and performing physical examinations. You will also have additional tests like ECGs (heart traces) to monitor your health.
You will receive either the study medicine, Namilumab, or a placebo, which looks identical but has no active ingredients. You won't know which one you're getting, and neither will the study doctors. This part of the study is called the 'double-blind' period. The medicines will likely be given over a set period, and there will be follow-up appointments to see how you're doing. The total duration of your participation, including the initial treatment phase and follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (4)
- —Germany
- —France
- —Netherlands
- —Belgium
Common questions
What is chronic pulmonary sarcoidosis?
It's a long-term lung condition where tiny clumps of cells grow in your lungs, which can affect your breathing and overall health.
What is Namilumab?
Namilumab is a new medicine being tested to see if it can help people with chronic pulmonary sarcoidosis.
What is a 'placebo'?
A placebo is a 'dummy' medicine that looks like the real study drug but doesn't contain any active ingredients. It helps us compare the effects.
Will I know if I'm getting the real medicine or the placebo?
No, during the main part of the study, neither you nor your study doctor will know if you're receiving Namilumab or the placebo. This helps keep the results fair.
How long will the study last?
The study team will tell you the exact duration, which includes the time you take the medicine and the follow-up visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.