A Phase 2, multicentre open-label study to explore the effects of sonelokimab in patients with moderate-to-severe pustulosis palmoplantaris
This research study is about a new treatment, called sonelokimab, for a skin condition known as palmoplantar pustulosis (PPP). PPP causes painful red spots and blisters on the palms of your hands and soles of your feet. This study is in its second phase, meaning it's still quite early and aims to explore how effective sonelokimab might be. Researchers will be looking at how much the skin condition improves in people taking the medicine over 16 weeks, using a special scoring system. They want to understand if sonelokimab can help reduce the symptoms of PPP. If you are an adult with moderate to severe PPP, you might be able to take part.
At a glance
What is this study about?
This study is exploring a new medicine called sonelokimab for a skin condition known as palmoplantar pustulosis (PPP). PPP is a long-lasting condition where you develop red, scaly patches and pus-filled bumps (pustules) mainly on the palms of your hands and the soles of your feet. These can be very uncomfortable, itchy, and sometimes painful, making everyday tasks difficult. The aim of this study is to see how well sonelokimab works to improve these symptoms.
This is a 'Phase 2' study, which means it's an earlier stage of research. The main goal at this stage is to understand if the medicine has a noticeable effect and to get a better idea of how it works in the body for people with PPP. It's also important to see if it's generally safe and what dose might be best. The study is 'open-label', meaning both you and the study team will know that you are receiving sonelokimab.
The main thing the researchers will be watching is how much your PPP symptoms, like the redness and pustules, improve after 16 weeks of treatment. They use a special scoring system to measure these changes. By understanding these effects, the study hopes to gather important information that could potentially lead to a new treatment option for people living with moderate to severe palmoplantar pustulosis.
Key takeaways
- This study is testing a new medicine, sonelokimab, for moderate-to-severe palmoplantar pustulosis (PPP).
- It's a 'Phase 2' study, focusing on how well the medicine works over 16 weeks.
- Adults (18+) with PPP can be considered for participation.
- Participation involves regular clinic visits, medical checks, and specific assessments.
- You'll get close medical monitoring, but there are potential risks and benefits to consider.
- You have the right to leave the study at any time.
Who may be eligible?
To take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also be considered.
This study is open to both men and women. The most important thing is that you have been diagnosed with moderate to severe palmoplantar pustulosis (PPP). This means your PPP needs to be causing significant symptoms that affect your hands and/or feet.
However, there will be other specific health checks and criteria that the research team will look at to make sure the study medicine is safe for you and that the results of the study are reliable. If you're interested, the study team will go through all the details to see if this study is a good fit 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 moderate-to-severe palmoplantar pustulosis (PPP)?
- Are you comfortable with regular hospital or clinic visits?
- Are you able to follow study instructions and attend appointments?
- Are you generally in good health apart from your PPP, or are any other health conditions well-managed?
- Are you willing to potentially try a new, experimental medicine?
What does participation involve?
If you decide to take part in this study, you would receive the new medicine, sonelokimab. The study team will explain exactly how you will take the medicine. Throughout the study, you would have regular visits to the clinic. At these visits, the research team would check on your health and how your skin condition is progressing. They would also take measurements of your PPP symptoms using a special scoring system (called the PPPASI score) to see if the medicine is helping.
These visits might include physical examinations, blood tests, and possibly other procedures to monitor your health and the effects of the treatment. There will also be follow-up appointments after you finish taking the medicine to make sure you are doing well. The total duration of your participation, including all treatment and follow-up, would be fully explained by the study team before you join.
Potential risks and benefits
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Common questions
What is palmoplantar pustulosis (PPP)?
It's a long-lasting skin condition that causes painful red patches and pus-filled bumps on the palms of your hands and soles of your feet.
What is sonelokimab?
It's a new medicine being tested in this study to see if it can help improve the symptoms of PPP.
What does 'Phase 2' mean for a study?
It means it's an earlier stage of research, exploring how well the medicine works and if it's generally safe, after initial safety checks.
How long will the study last if I join?
The study will look at changes in your skin condition after 16 weeks, and the full length of your participation, including follow-up, will be explained by the study team.
Will I know if I'm getting the study medicine?
Yes, this is an 'open-label' study, meaning both you and the research team will know you are receiving sonelokimab.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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