Are you interested in taking part in the study?
If you are a patient who is interested in taking part in the study, please register your interest here.
Can I take part?
APRICOT is open to both men and women, in the UK.
To take part you must be:
- 18 years old or over
- Have a confirmed diagnosis of palmo-plantar pustulosis (PPP)
- Have had PPP for more than 6 months which hasn’t been responding to topical therapy (i.e corticosteroid creams)
- Have lots of pustules on the area(s) affected
You may not be able to take part if you
- Have other serious illnesses
- Are prone to infections
- Are pregnant, breastfeeding or planning conception
Download our Participant Information Leaflet [pdf] for more information.
If you decide to take part in APRICOT you will need to sign a consent form and attend clinic for a screening visit to confirm your eligibility.
Participants will be asked to attend clinic visits on seven different occasions:
Screening, Baseline (week 0), week 1, week 4, week 8, and Follow up at week 12 and 90 days after your last dose.
The treatment period is eight weeks long and the treatment is administered by daily injection under the skin. You will receive training on how to self-administer the injections so that you can do so at home and only need to attend clinic for the scheduled trial visits.
APRICOT is a randomised placebo matched trial. This means there is a 50:50 chance that participants will be randomised to either the anakinra or placebo treatment groups. A placebo looks like the active medicine but contains no active ingredient.
Regardless of treatment group you will be asked to stop any current psoriasis therapy you may be taking for the duration of the trial. APRICOT is also a blinded trial meaning no one involved, including both participants and study team, will know which treatment you have been taking until the very end.
At clinic visits your general health will be assessed and specific trial related assessments of your hands and feet will be conducted (e.g. pustules will be counted). Participants will also be asked to complete some quality of life related questionnaires.
Anakinra, like other biologic treatments for psoriasis, acts through suppressing the immune system and has a number of known side effects. Please read our Participant Information Leaflet [pdf] for more information.
As well as testing anakinra as a potential new treatment for PPP, we are also hoping to collect information from participants that will help to explain why and how people get the disease. To do this we will collect blood samples at various time points throughout the trial in order to look at genes (DNA) and other molecules. In total this will be 75ml (about 15 teaspoons, or about 12 standard blood test tubes) spread over eight weeks. There is also the option of providing two skin samples.
Open Label Extension (OLE)
Patients who have completed the 8 week treatment period schedule, as well as the 12 week follow up visit, of the double-blind placebo controlled study can take part in an optional 8 week period of anakinra treatment, as an Open Label Extension to the trial.
Participants will be asked to attend clinic visits on at least five more occasions during their Open Label Extension treatment.
The Open Label Extension treatment period is eight weeks long and the anakinra treatment is administered by daily injection under the skin. You will receive training on how to self-administer the anakinra injections so that you can do so at home and only need to attend clinic for the scheduled Open Label Extension visits.
Download our OLE Participant Information Leaflet [pdf] for more information.
Who we are
We are a multidisciplinary clinical trial team based at Guy’s Hospital, London, UK, led by Professor Catherine Smith at the St John’s Institute of Dermatology. As a clinical and academic unit we are building on our scientific work into a rare disease (palmo-plantar pustulosis) with this important investigator led, grant funded, trial.
APRICOT collaborators based around the country have been involved in the project from the beginning and will also be instrumental in influencing the direction of the trial as part of the trial management group.
APRICOT is sponsored by Guy’s and St Thomas’ NHS Foundation Trust and is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership.
Why are we doing this trial?
We want to test whether a drug called anakinra (Kineret®) has any beneficial effect on palmo-plantar pustulosis (PPP).
Palmo-plantar pustulosis is a rare form of psoriasis and for many people, the treatments available do not work, or cause unacceptable side effects. Recent research has shown that PPP may be caused by an abnormal pathway involving a protein called interleukin-1 (IL-1). Anakinra specifically blocks this IL-1 pathway. Daily treatment (injections) with anakinra may therefore prove to be an effective way of reducing PPP symptoms and is what we are setting out to test with this trial.
Anakinra is already licensed for use in other inflammatory conditions (such as rheumatoid arthritis) and has a good safety profile.