CompletedPhase IVInterventional

An assessment of the acceptability and practicality of using Janus kinase inhibitors to treat palmoplantar pustulosis

Palmoplantar pustulosis (PPP) is a long-lasting skin condition that causes painful, red patches and yellow blisters on the palms of the hands and soles of the feet. Strong prescription creams often fail to clear it up. This small study is testing a daily tablet called upadacitinib to find out if it is practical and acceptable for people living with PPP. Upadacitinib belongs to a family of medicines called JAK inhibitors, which reduce inflammation and are already used for other skin conditions. Because these medicines require close safety monitoring, researchers want to check whether patients are comfortable taking them and attending regular check-ups. Participants will take the tablet once a day for 8 weeks and attend hospital appointments with blood tests at Guy’s and St Thomas’ in London. The results will help doctors decide if a larger UK-wide trial is possible.

At a glance

Status

Completed

Phase

Phase IV

Enrolment target

Start

14 Nov 2024

Estimated completion

02 Feb 2026

Palmoplantar pustulosis

What is this study about?

Palmoplantar pustulosis (PPP) is an uncommon, painful skin condition. It leads to reddened skin and small, pus-filled blisters on the palms of the hands and soles of the feet. Because our hands and feet are used constantly, everyday activities like walking, working, or doing household chores can become very uncomfortable. Standard treatments, such as strong steroid creams, often do not provide enough relief, leaving many patients looking for better alternatives.

This trial is looking at an anti-inflammatory tablet called upadacitinib. It belongs to a group of medicines known as Janus kinase (JAK) inhibitors. These work by calming down the overactive signals in the immune system that cause skin inflammation. While upadacitinib has shown promise in treating severe skin conditions, it can also cause side effects and requires careful health checks. Before launching a large clinical trial across the UK, doctors need to know whether patients find taking this tablet safe, manageable, and worthwhile.

By taking part, participants help doctors understand the real-world practicalities of this treatment. Researchers will gather feedback through short questionnaires and one-to-one chats. This information will show what works well and what might need changing, laying the groundwork for future treatments for people with PPP across the NHS.

Key takeaways

Tests whether a daily tablet (upadacitinib) is a practical and acceptable treatment for palmoplantar pustulosis.
Treatment lasts for 8 weeks, with regular safety monitoring visits lasting up to 20 weeks in total.
All hospital visits take place in person at Guy’s and St Thomas’ NHS Trust in London.
Aimed at adults whose skin has not improved with strong prescription creams.
Findings will help researchers design a larger national trial to improve NHS treatment options.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with palmoplantar pustulosis by a skin specialist (dermatologist). To take part, your symptoms must have lasted for at least six months and not improved after trying strong steroid creams. You must also have active blisters on your hands or feet at the start of the study.

Because of safety guidance around JAK inhibitors, some people cannot join. You will not be able to take part if you have had cancer in the past five years (except for successfully treated non-melanoma skin cancer), if you have a history of serious blood clots (unless you take long-term blood thinners), or if you have had recurring serious infections such as tuberculosis or HIV. You also cannot join if you have taken a JAK inhibitor medicine before.

Many people with PPP are current or past smokers. Having a history of smoking will not automatically exclude you from the trial, but the study team will carefully check your overall heart health to ensure taking part is 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.

I am aged 18 or older.
A dermatologist has diagnosed me with palmoplantar pustulosis.
I have had the condition for at least 6 months, and strong creams have not worked.
I currently have visible blisters on my hands, feet, or both.
I have not had cancer in the last 5 years or serious blood clots without medication.
I am able to attend regular monitoring appointments in London over 20 weeks.

Answer every question to see your result.

What does participation involve?

If you join the trial, you will take one 30 mg tablet of upadacitinib once daily for 8 weeks. Your overall involvement in the study will last about 20 weeks. During this time, you will need to travel in person to Guy’s and St Thomas’ NHS Trust in London for check-ups at the start, at weeks 1, 2, 4, 8, and 12, followed by a final safety check at week 20. At these visits, doctors will inspect your skin, take routine blood samples, and check your blood pressure. You will also need a chest X-ray unless you have had one in the past year. In addition, you will be invited to a 60-minute interview, either in person or over video call, to share your thoughts on the treatment. While taking the medicine, you will need to avoid having any 'live' vaccines.

Potential risks and benefits

Taking part may help clear your skin blisters and ease discomfort, though this cannot be guaranteed. The study also helps improve future medical care for PPP. Potential risks include common side effects linked to upadacitinib, such as minor infections, nausea, or headaches. JAK inhibitors also carry small risks of blood clots and heart problems in people with existing risk factors, which is why your health and blood will be monitored very closely. Having blood taken can cause brief discomfort or slight bruising. Joining the trial is entirely your choice, and you can withdraw at any time without your regular NHS care being affected in any way.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Guys Hospital
City only
London, England

Common questions

Where does this study take place?

All clinic visits take place in person at Guy's and St Thomas' NHS Trust in London. The one-hour feedback interview can be done either in person or from home via a Microsoft Teams video call.

Can I take part if I smoke or used to smoke?

Yes. Smoking is very common in people with palmoplantar pustulosis, so smokers are not excluded. However, the study doctor will review your overall heart and blood vessel health before you can join.

Will I have to pay for the medication?

No. The study tablet, hospital tests, and check-ups related to the clinical trial are provided free of charge.

What happens if I change my mind during the study?

You are free to leave the trial at any point, for any reason. Deciding to stop will not affect your relationship with your healthcare team or your normal NHS treatment.

Why do I need so many blood tests?

Upadacitinib affects parts of your immune system. Regular blood tests allow the medical team to check that your liver, kidneys, and blood cells stay healthy throughout the study.

How to find out more

David Gleeson

david.gleeson@kcl.ac.uk +44 (0)20 7188 7188 ext 6072 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.