A Randomized, Double-Blind, Placebo-controlled, Safety and Efficacy Study of VI-0106 (Extended-release Tacrolimus) in Subjects with PAH and Functional Limitations Despite Optimized Therapy with Available PAH Medications
Pulmonary arterial hypertension (PAH) is a serious condition causing high blood pressure in the blood vessels that supply the lungs. This can make everyday activities exhausting and leave people feeling breathless. Even with current NHS treatments, many people still experience limits in their day-to-day life. This Phase III clinical trial is testing a medicine called VI-0106 (an extended-release form of tacrolimus). Researchers want to find out if adding VI-0106 to standard treatments can help patients walk further in six minutes and improve their general well-being. Participants will be randomly assigned to take either VI-0106 or a dummy pill (placebo) alongside their regular medication. The study lasts around 28 weeks and involves regular check-ups, walking tests, and blood monitoring to see if the medicine is safe and effective.
At a glance
What is this study about?
Pulmonary arterial hypertension (PAH) occurs when the blood vessels leading to the lungs become stiff and narrowed. This forces the right side of the heart to work much harder to pump blood through them, leading to symptoms like extreme tiredness, dizziness, and breathlessness. While modern treatments help manage PAH, many people still find it difficult to walk short distances or do routine household chores.
This trial is looking at a medicine called VI-0106, which contains a drug called tacrolimus. Tacrolimus is already used in other areas of medicine, but scientists believe it may also help repair or protect damaged blood vessels in the lungs. The tablet is designed to release the drug slowly into the body over time.
The main goal of the trial is to see whether people taking VI-0106 can walk further in a six-minute walking test after 24 weeks compared to those taking a dummy pill (placebo). The researchers also want to find out if the treatment reduces hospital visits, helps people feel better in everyday life, and keeps working even after a brief pause in treatment.
By taking part, participants help doctors learn whether VI-0106 could become a useful add-on treatment for people across the UK living with PAH.
Key takeaways
- Tests whether adding VI-0106 to current PAH treatment helps people walk further.
- Designed for adults aged 18 and older who still have breathing limits on their current medication.
- Participants take either the trial medicine or a dummy pill (placebo) for about 28 weeks.
- Involves regular clinic visits, walking tests, and blood monitoring.
- Taking part is voluntary and does not replace your standard NHS care.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with pulmonary arterial hypertension (PAH).
To be considered, you must already be taking standard, approved PAH medicines, but still find that your symptoms limit what you can do physically each day.
The study team will run health checks and review your medical history to make sure your kidneys, heart, and general health are stable enough for you to join safely.
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.
- I am aged 18 or older.
- I have been diagnosed with pulmonary arterial hypertension (PAH).
- I am already taking standard medicines for my PAH.
- I still feel breathless or tired during everyday activities despite my treatment.
- I am able and willing to attend regular hospital check-ups and complete walking tests.
What does participation involve?
If you join this trial, you will take part for around 28 weeks. You will be given either VI-0106 capsules or dummy capsules (placebo) to swallow regularly, taken on top of your standard PAH medicines. Neither you nor your doctor can choose which capsule you receive, as this is decided at random by a computer.
During the study, you will visit the clinic regularly. At these visits, doctors will measure how far you can walk in six minutes, check your blood pressure and heart health, take small blood samples, and ask about your symptoms and daily activities. Around week 24, there may be a short four-week pause in the study tablets to see how your body responds before a final assessment at week 28.
Potential risks and benefits
Locations (7)
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedLatvia
- —UnverifiedGermany
- —UnverifiedSpain
Common questions
What is a placebo?
A placebo is a dummy pill that looks and tastes identical to the real medicine but contains no active drug. It allows researchers to see if changes in health are truly caused by the study drug.
Will I have to stop taking my usual PAH medication?
No. You will continue to take your standard prescribed PAH treatments throughout the study.
Will I or my doctor know if I am getting the real medicine?
No. This is a 'double-blind' trial, which means neither you nor your clinical team will know who is taking VI-0106 and who is taking the placebo, until the study is finished.
What is the six-minute walk test?
It is a standard, gentle test where you walk at your own pace along a flat corridor for six minutes. It helps doctors see how your lungs and heart cope with light exercise.
Can I leave the study if I change my mind?
Yes. Taking part is completely voluntary, and you can stop at any point without giving a reason and without losing any of your standard medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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