A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of KER-012 in Combination with Background Therapy in Adult Participants with Pulmonary Arterial Hypertension (TROPOS-Study)
This research study, called TROPOS, is looking into a new medicine called cibotercept (also known as KER-012) for adults who have pulmonary arterial hypertension (PAH). PAH is a condition where the blood pressure in the arteries leading to your lungs is too high. The main goal is to find out if this new medicine, when taken alongside your usual treatments, can make a difference in how well blood flows through your lungs after 24 weeks. Researchers will also be checking carefully for any side effects and seeing if it improves how far people can walk in six minutes. Half the participants will get the new medicine, and the other half will get a dummy treatment (placebo) to compare the results fairly.
At a glance
What is this study about?
This study is investigating a new medication called cibotercept, which is also known by its code KER-012. It's designed for people who have a condition called Pulmonary Arterial Hypertension (PAH). PAH is quite a serious condition where the blood vessels in the lungs become narrow and stiff, making it harder for the heart to pump blood through them. This causes high blood pressure specifically in the arteries of your lungs, which can lead to symptoms like breathlessness and tiredness.
The main purpose of this study is to see if cibotercept, when added to medicines you might already be taking for PAH, can help your lung blood vessels work better. The researchers will be looking closely at how easily blood can flow through your lungs after 24 weeks of treatment. This is a 'Phase 2' study, meaning it's an early stage where scientists are still exploring how well the medicine works and carefully checking its safety before it can be considered for wider use.
Alongside checking how blood flows through your lungs, the study will also monitor other important things. This includes how far you can walk in six minutes, which is a common way to measure how PAH affects your daily activity. They will also be meticulously recording any side effects that might occur, as well as checking your general health using blood tests, vital signs (like heart rate and blood pressure), and heart scans (ECGs). This helps build a full picture of the medicine's effects.
Key takeaways
- Tests a new medicine (cibotercept) for Pulmonary Arterial Hypertension (PAH).
- Aims to see if the medicine improves blood flow in lung vessels.
- Compares the new medicine to a dummy treatment (placebo).
- Carefully checks for safety and side effects.
- Participants will attend regular visits over 24 weeks.
- Open to adults aged 18 and over, both men and women.
Who may be eligible?
This study is looking for adult participants. To join, you must be at least 18 years old – there is no upper age limit stated. Both men and women are welcome to take part in this research.
However, having pulmonary arterial hypertension is the specific health condition this study is focusing on. There will be other specific health requirements and exclusions that aren't listed here. For example, your doctor will need to check your general health, your current PAH treatment, and other medical conditions you might have to ensure the study is safe and suitable 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 Pulmonary Arterial Hypertension (PAH)?
- Are you currently on background therapy (other treatments) for your PAH?
- Are you able to attend clinic appointments regularly for about 6 months?
What does participation involve?
If you decide to take part in this study, you'll be assigned by chance to either receive the new study medicine, cibotercept, or a dummy treatment (placebo) along with your current PAH medication. Neither you nor your study doctor will know which one you are receiving – this is to make sure the results are as fair and unbiased as possible. You will be asked to attend regular clinic visits over a period of 24 weeks (about 6 months).
During these visits, the study team will carry out various assessments. These will likely include physical examinations, blood tests, checks of your vital signs (like blood pressure and heart rate), heart scans (ECGs), and a test to see how far you can walk in six minutes. They will also regularly ask you questions about how you are feeling and any side effects you might be experiencing. The study will aim to track your progress and safety over this 24-week period.
Potential risks and benefits
Locations (5)
- —UnverifiedGermany
- —UnverifiedPortugal
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedFrance
Common questions
What is Pulmonary Arterial Hypertension (PAH)?
PAH is a serious condition where the blood pressure in the arteries going from your heart to your lungs is too high, making it harder for your heart to pump blood.
What is cibotercept (KER-012)?
Cibotercept is a new medicine being tested in this study to see if it can help improve blood flow in the lungs for people with PAH.
What does 'Phase 2' study mean?
Phase 2 means it's an early stage of testing for a new medicine, focusing on whether it works and carefully checking for side effects in a group of patients.
Will I know if I'm getting the old or new treatment?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know if you're receiving the new medicine or a dummy treatment (placebo).
How long will I be in the study?
The main treatment part of this study will last for 24 weeks, which is about 6 months, with regular visits to the clinic.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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