A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
This study is investigating a new medicine called nerandomilast for people who have scarring in their lungs (lung fibrosis) caused by certain rheumatic diseases. It's for adults whose lung function hasn't improved with their usual immunosuppressant medications. Participants will be randomly assigned to take either nerandomilast or a dummy pill (placebo) twice a day for at least 26 weeks, while continuing their current treatment. Throughout the study, which lasts 7.5 to 13 months, they'll have regular hospital visits for lung function tests, scans, and to complete questionnaires about their health. Doctors will carefully monitor their health and any side effects to see if nerandomilast helps improve lung health.
At a glance
What is this study about?
This study, called a Phase 3 trial, is looking into a new medicine called nerandomilast. It's designed for people who have a condition called lung fibrosis (or scarring in the lungs) that is linked to a rheumatic disease. Rheumatic diseases are conditions where your immune system mistakenly attacks your own body, and sometimes this can affect the lungs, leading to scarring.
The main goal of this study is to find out if nerandomilast can help improve lung function in people whose lung scarring hasn't got better with their usual treatments. Currently, people with this type of lung fibrosis often take medicines that calm down their immune system (immunosuppressants). This study is for those who haven't seen enough improvement in their breathing or lung function with these standard medicines.
By comparing nerandomilast to a dummy pill (placebo), the researchers hope to understand how effective this new medicine is at targeting the lung scarring. The information gathered will be crucial in deciding if nerandomilast could become a new treatment option for people living with this challenging condition.
Key takeaways
- This study evaluates a new drug, nerandomilast, for lung scarring linked to rheumatic diseases.
- It's for adults whose lung function hasn't improved with standard medicines.
- Participants take tablets twice daily and have regular lung tests and check-ups.
- You might receive the active drug or a placebo, but your health will be closely monitored.
- Your current rheumatic disease medicines must be continued.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is designed for adults aged 18 and older who have scarring in their lungs (fibrotic interstitial lung disease) caused by certain rheumatic conditions. This includes specific types of rheumatoid arthritis, systemic sclerosis (but not if you have a particular antibody called anticentromere), idiopathic inflammatory myopathy, Sjögren's disease, or mixed connective tissue disease (if you have the anti-U1-RNP antibody).
You would only be eligible if your lung condition hasn't improved with your current immunosuppressant medicines. This means your lung function tests (like how much air you can breathe out, called FVC) shouldn't have shown significant improvement over the past 15 months, and your doctor also agrees that your lung condition isn't getting better.
Additionally, your current lung function needs to be within a certain range: your FVC must be at least 45% of what's expected for someone your age, and another lung test (DLCO) must be at least 25% of what's expected.
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 an adult aged 18 or over?
- Do you have lung scarring (fibrosis) caused by a rheumatic disease (like specific types of rheumatoid arthritis, scleroderma, or Sjögren's)?
- Has your lung function not significantly improved with your current immunosuppressant medicines?
- Is your specific type of rheumatic disease one of those listed for the study (e.g., certain antibodies are required or excluded for some conditions)?
- Are your current lung function test results (FVC and DLCO) within specific limits?
What does participation involve?
If you join this study, you'll be involved for about 7.5 to 13 months, depending on when you start. You will be randomly put into one of two groups: one group will receive the study medicine, nerandomilast, and the other will receive a placebo, which looks identical but contains no active medicine. You will take one tablet, twice a day, for at least 26 weeks (about six months) and potentially up to a year. It's important that you continue taking your usual immunosuppressant medicine for your rheumatic disease throughout the study.
During this time, you'll have roughly 9 to 10 visits to the study clinic. At these visits, doctors will perform lung function tests to see how well your lungs are working. Some visits will also include chest scans to get a detailed look at your lungs. You will also be asked to complete questionnaires about your symptoms and how your quality of life is being affected. Your health will be closely monitored, and any side effects you experience will be carefully recorded.
Potential risks and benefits
Locations (158)
- University of Alabama at BirminghamVerified postcodeBirmingham, United States· Recruiting
- Mayo Clinic-ArizonaVerified postcodeScottsdale, United States· Recruiting
- University of California Los AngelesVerified postcodeLos Angeles, United States· Not yet recruiting
- Paradigm Clinical Research - San DiegoVerified postcodeSan Diego, United States· Recruiting
- National Jewish HealthVerified postcodeDenver, United States· Recruiting
- Yale University School of MedicineVerified postcodeNew Haven, United States· Recruiting
- Meris Clinical Research-Brandon-69466Verified postcodeBrandon, United States· Not yet recruiting
- Miami VA Healthcare SystemVerified postcodeMiami, United States· Recruiting
- Piedmont Physicians Pulmonary & Sleep Medicine of BuckheadVerified postcodeAtlanta, United States· Recruiting
- Augusta UniversityVerified postcodeAugusta, United States· Not yet recruiting
- Northwestern UniversityVerified postcodeChicago, United States· Recruiting
- The University of Chicago Medical CenterVerified postcodeChicago, United States· Not yet recruiting
Common questions
What is lung fibrosis?
Lung fibrosis is a condition where the normal tissue in the lungs becomes scarred and thick, making it harder to breathe and for the lungs to work properly.
What are rheumatic diseases?
Rheumatic diseases are conditions where the body's immune system mistakenly attacks its own healthy tissues, which can sometimes affect the lungs.
What is a placebo?
A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers fairly compare the new medicine's effects.
Will I know if I'm taking the real medicine or the placebo?
No, you won't know whether you're taking nerandomilast or the placebo. This is standard practice in studies to ensure unbiased results.
Can I stop my current medicines if I join the study?
No, you must continue your usual immunosuppressant treatment for your rheumatic disease throughout the study as instructed by your doctor.
How to find out more
Boehringer Ingelheim
Always speak to your GP or specialist before deciding to take part in a study.
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