A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
This study is looking into a new medicine called nerandomilast for people living with systemic sclerosis. Researchers want to find out if this medicine can help improve symptoms and slow down how the disease progresses. The study is open to adults aged 18 and over who have systemic sclerosis, specifically those with limited or diffuse cutaneous types, and whose symptoms (not including Raynaud's) started within the last seven years. Participants will be split into two groups by chance: one will take nerandomilast, and the other a placebo (a tablet with no medicine). Doctors will closely monitor participants' health, including changes in their skin, lungs, and other organs, to see if the treatment works and if it's well-tolerated.
At a glance
What is this study about?
Systemic sclerosis is a long-lasting condition that affects the body's connective tissues, which support organs and other parts of the body. It can cause hardening and tightening of the skin, and sometimes affects internal organs like the lungs, heart, and kidneys. There's currently no cure, but treatments can help manage the symptoms. This study is exploring a new medicine called nerandomilast.
The main goal of this research is to see if nerandomilast can help people with systemic sclerosis by making their symptoms better or slowing down the disease's progress. It also aims to understand how safe the medicine is and if people can take it without too many unwanted side effects. Finding effective treatments for systemic sclerosis is really important for improving the quality of life for those affected by it.
This is a 'Phase 3' study, which means the medicine has already been tested in smaller groups and shown some promise. Now, researchers need to test it in a larger group of people to confirm its benefits and get a more complete picture of its safety before it could potentially be made widely available. We hope to learn a lot more about nerandomilast and its potential role in helping people with this condition.
Key takeaways
- This study is testing a new medicine called nerandomilast for systemic sclerosis.
- It aims to see if the medicine improves symptoms, slows disease, and is safe.
- Adults with specific types and recent onset of systemic sclerosis may be eligible.
- Participants take tablets twice a day and have regular health check-ups.
- You might receive the active medicine or a placebo, chosen by chance.
- The study lasts between 1 to 4 years with close medical monitoring.
Who may be eligible?
This study is for adults aged 18 or older who have been diagnosed with systemic sclerosis. This includes people with either limited or diffuse cutaneous systemic sclerosis. An important point is that your systemic sclerosis, not including your Raynaud's phenomenon, should have started within the last 7 years.
To ensure the medicine is being tested on people who might benefit most, there are a few other specific requirements. For example, your lung function needs to be within a certain range, and women who could become pregnant must be using effective birth control. You cannot join if you have certain active health problems, like uncontrolled inflammation of blood vessels, or if you've had specific thoughts about harming yourself in recent times.
It's important to remember that these are just some of the key points, and doctors will check many other things to make sure the study is right and safe for you. Taking part in a clinical trial is a big decision, and your doctors will help you understand if you meet all the requirements.
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 a diagnosis of systemic sclerosis (either limited or diffuse cutaneous type)?
- Did your systemic sclerosis symptoms (not including Raynaud's) start within the last 7 years?
- Are you able to attend regular clinic visits for blood tests and health checks?
- If you are a woman who could become pregnant, are you using effective birth control methods?
- Have you discussed with your doctor if any other health conditions might prevent you from joining?
What does participation involve?
If you join this study, you'll be part of it for about 1 to 4 years. You'll be randomly assigned to one of two groups: one will take the new medicine, nerandomilast, and the other will take a 'placebo' – a tablet that looks exactly the same but contains no active medicine. You won't know which one you're taking, and neither will the study team, which helps ensure unbiased results. You'll need to take the tablets twice a day.
During the study, you'll have regular visits to the study clinic and some phone calls with the staff. At these visits, doctors will carefully monitor your health. This involves giving blood samples, checking your skin thickness, measuring your lung function, and looking at how your other internal organs are doing. They will also assess your overall health and ask about any new symptoms or side effects you might experience. These regular check-ups are crucial to understand how the medicine is working and to ensure your safety throughout the study.
Potential risks and benefits
Locations (236)
- University of Alabama at BirminghamVerified postcodeBirmingham, United States
- Banner - University Medicine Rheumatology ClinicVerified postcodePhoenix, United States
- Arizona Arthritis and Rheumatology Associates - Paradise ValleyVerified postcodeScottsdale, United States
- University of California Los AngelesVerified postcodeLos Angeles, United States
- Paradigm Clinical Research - San DiegoVerified postcodeSan Diego, United States
- Stanford University School of MedicineVerified postcodeStanford, United States
- Medvin Clinical Research-Whittier-69033Verified postcodeWhittier, United States
- University of Colorado DenverVerified postcodeAurora, United States
- Georgetown UniversityVerified postcodeWashington D.C., United States
- Millennium Research - Ormond BeachVerified postcodeOrmond Beach, United States
- Integral Rheumatology and Immunology SpecialistVerified postcodePlantation, United States
- BioResearch Partner - South MiamiVerified postcodeSouth Miami, United States
Common questions
What is systemic sclerosis?
Systemic sclerosis is a condition where your body's tissues, especially the skin, become hard and tight. It can also affect internal organs like the lungs and heart.
What is a placebo?
A placebo is a tablet that looks like the study medicine but doesn't contain any active drug. It helps researchers compare the new medicine's effects against doing nothing.
How long will I be in the study?
If you join, you will be in the study for about 1 to 4 years, depending on the study plan.
Will I know if I'm getting the active medicine or a placebo?
No, neither you nor the study team will know which you are taking. This is called 'blinding' and helps ensure fair and accurate results.
What happens after the study ends?
After the study, your regular medical care for systemic sclerosis will continue as before. The study results will help scientists understand if nerandomilast could be a future treatment option.
How to find out more
Boehringer Ingelheim
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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