Randomized double blind controlled trial comparing the safety and efficacy of apremilast versus placebo in severe forms of recurrent aphthous stomatitis - PREMS - 2019/0411/HP
This research study, called PREMS, is looking for people aged 18 and older who suffer from severe mouth ulcers that keep coming back. These are often known as recurrent aphthous stomatitis (RAS). We are comparing a new medicine called apremilast with a dummy pill (placebo) to see how safe and effective it is. The main goal is to find out if apremilast can help heal these painful ulcers and keep them away for a longer period. We'll be checking if participants have no ulcers at specific points during the study. An independent expert, who won't know which treatment you're getting, will carefully check your mouth. This helps make sure the results are fair and accurate. Another medicine, racecadotril, is also part of this study.
At a glance
What is this study about?
If you often get painful mouth ulcers that are severe and keep coming back, you know how uncomfortable and disruptive they can be. This condition is called Recurrent Aphthous Stomatitis (RAS). This study, known as PREMS, is designed to investigate a new medication called apremilast. We want to understand if apremilast can make a real difference for people struggling with this condition, specifically by reducing the ulcers and preventing them from coming back frequently.
To find out if apremilast works, we're comparing it to a 'dummy pill' or placebo. This is a common way to test new medicines and helps us see if the effects are truly due to the medicine itself and not just chance or people expecting to feel better. Neither you, nor your study doctor, will know whether you are receiving apremilast or the placebo. This is called a 'double-blind' study and helps ensure the results are as fair and unbiased as possible. Another medicine called racecadotril is also being looked at as part of this study.
The main aim of the study is to see if participants taking apremilast can achieve a 'sustained complete response'. This means having no mouth ulcers at specific check-up times (at Week 12, Week 14, and Week 16). An independent expert, who won't know which treatment you're on, will examine your mouth to confirm if you are ulcer-free. This careful approach helps us ensure we accurately measure how well the treatment is working and if it offers lasting relief.
Key takeaways
- This study is testing a new medicine called apremilast for severe, recurring mouth ulcers.
- It compares apremilast to a dummy pill (placebo) to see if it works better.
- The study involves checking for mouth ulcers at specific times (e.g., Week 12, 14, 16).
- You won't know if you're getting the active medicine or the placebo.
- Adults aged 18 and over with severe recurring mouth ulcers can apply.
- Your decision to participate is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for adults aged 18 and over. There is no upper age limit, meaning anyone over 18 can be considered.
Both men and women are welcome to take part in this research.
The most important requirement is that you experience severe forms of mouth ulcers that keep coming back. This condition is known medically as recurrent aphthous stomatitis (RAS). The study is specifically for people whose mouth ulcers are a significant and ongoing problem.
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 suffer from severe mouth ulcers that keep coming back?
- Are you able to attend study visits as required?
- Are you willing to take study medication (either apremilast or a dummy pill) as instructed?
What does participation involve?
If you decide to take part, you will be randomly assigned to one of two groups. One group will receive the study medicine, apremilast, and the other will receive a dummy pill (placebo). There's also another treatment called racecadotril involved. You will take the study medication regularly as instructed by the study team.
You will have several scheduled visits to the clinic for assessments. These visits will involve careful checks of your mouth to see if you have any ulcers, how big they are, and if they are healing. These checks will be done by an expert who doesn't know which treatment you are receiving. You might also be asked about any side effects you experience, especially any stomach or digestive issues, as these can sometimes occur with apremilast. The exact number of visits and the full duration of the study are not detailed here, but the primary goal is to assess your ulcer status at Week 12, Week 14, and Week 16.
Potential risks and benefits
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Common questions
What are severe recurrent aphthous stomatitis (RAS)?
These are mouth ulcers that are severe, very painful, and keep coming back frequently. They can sometimes interfere with eating and speaking.
What is apremilast?
Apremilast is a medication being tested to see if it can help reduce and prevent these severe mouth ulcers.
What is a 'dummy pill' or placebo?
A placebo is a pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects.
Will I know if I'm getting the real medicine?
No, this is a 'double-blind' study, meaning neither you nor your doctor will know if you're getting apremilast or the dummy pill until after the study is over.
What is the main goal of this study?
The main goal is to see if apremilast can help people achieve lasting relief from their mouth ulcers, meaning no ulcers at several check-ins.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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