A Phase II, randomised, placebo-controlled, double-blind, parallel-group, efficacy and safety study of at least 48 weeks of oral BI 685509 treatment in adults with progressive systemic sclerosis
This research study is looking at a new tablet, BI 685509, for adults who have systemic sclerosis. This condition can cause skin changes and affect internal organs, including the lungs. The main goal is to find out if this new tablet can help prevent the lungs from getting worse over 48 weeks, compared to a dummy pill (placebo). Researchers will also check if it improves skin thickness, daily activities, and other parts of the condition. Half the participants will get the actual drug, and half will get the dummy pill, but neither they nor their doctors will know who is getting what. This helps get accurate results about the drug's effects and safety.
At a glance
What is this study about?
This study is designed to learn more about a new medicine called BI 685509. It's for adults living with a condition called systemic sclerosis. This is a long-term condition that causes the body's immune system to attack its own tissues, leading to hardened skin and problems with internal organs like the lungs, heart, or digestive system. The ‘progressive’ part in the title means the condition is getting worse over time.
In this study, researchers want to see if BI 685509 can help slow down one of the most serious effects of systemic sclerosis: the worsening of lung function. They will measure how much air people can breathe out Forcefully, called 'forced vital capacity' (FVC), to see if the new medicine makes a difference compared to a dummy pill. If the medicine can protect the lungs, it could be a significant step forward for people with this condition.
The study will also look at other important aspects of systemic sclerosis. This includes changes in skin thickness, how well people can do their daily activities, and how they feel about their condition overall. Safety is also a major focus, so researchers will carefully track any side effects to make sure the treatment is not only effective but also safe for patients.
Key takeaways
- This study is testing a new tablet for systemic sclerosis.
- It aims to slow down lung damage and improve other symptoms.
- Participants will take either the new drug or a dummy pill for at least 48 weeks.
- Close medical monitoring will be provided throughout the study.
- Both the potential benefits and risks will be carefully considered.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for adult volunteers, aged 18 years or older, who have systemic sclerosis. Both men and women are welcome to take part.
To be considered for the study, your doctor will need to check if your specific type and stage of systemic sclerosis match the study's requirements. This is important to ensure the study is right for you and that the results will be clear.
Before you can join, you'll have a thorough health check-up. This is to confirm you meet all the necessary health criteria and that taking part in the study would be safe for you.
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?
- Are you able to take tablets by mouth?
- Are you willing to make regular clinic visits for about a year (or longer)?
What does participation involve?
If you join this study, you would be taking a tablet called BI 685509 or a dummy pill (placebo) every day for at least 48 weeks. Neither you nor your study doctor would know which one you are taking. You would need to come to the clinic regularly for appointments. During these visits, the study team would perform various checks.
These checks would include lung function tests, like measuring your forced vital capacity (FVC) to see how your breathing is doing. They would also measure your skin thickness, ask you about your daily activities, and how you are feeling generally. There would be blood tests and other assessments to monitor your health and any potential side effects. The total duration of active treatment would be at least 48 weeks (just under a year), with potential for an extended period, and your progress would be carefully monitored throughout.
Potential risks and benefits
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Common questions
What is systemic sclerosis?
It's a long-term condition where your immune system attacks your body's own tissues, leading to hardened skin and problems with internal organs, like the lungs.
What does 'placebo-controlled' mean?
It means some people get the actual medicine and some get a dummy pill (placebo). This helps researchers see if the real medicine is truly making a difference.
What is 'forced vital capacity (FVC)'?
It's a measurement of how much air you can breathe out of your lungs in one deep breath. It helps doctors understand how well your lungs are working.
How long will the study last?
The main part of the treatment will last for at least 48 weeks (just under a year), with potential for an extended treatment period afterwards.
Will I know if I'm getting the real medicine or the dummy pill?
No, neither you nor your doctor will know during the study. This is called 'double-blind' and helps ensure the results are accurate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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