JAKPPPOT Trial

• Research type

  Research Study

• Full title

  JAnus Kinase inhibitors in PalmoPlantar PustulOsis: a mixed-methods feasibiliTy trial.

• IRAS ID

  346783

• Contact name

  Catherine Smith

• Contact email

  catherine.smith@kcl.ac.uk

• Sponsor organisation

  King's College London

• ISRCTN Number

  ISRCTN61751241

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  Aims:
  Palmoplantar pustulosis (PPP) is a rare, debilitating condition, causing painful, red skin with pus-filled lumps on the hands and feet that are difficult to treat. A new group of drugs, called Janus kinase (JAK) inhibitors, show promise in the treatment of PPP in some reported cases. However, these drugs also carry a risk of side effects which are more common in people with long-term health conditions.
  We need to know whether JAK inhibitors are an acceptable treatment for PPP. To do this, we will carry out a small-scale trial investigating whether people with PPP are happy to take JAK inhibitors and whether a larger clinical trial investigating JAK inhibitors
  in PPP is possible.

  Methods:

  This is a single-arm, open-label trial exploring the feasibility of using JAK inhibitors as a treatment for PPP. 20 adult participants (>18 years old) will receive a daily tablet of upadacitinib (30mg once-a-day) for 8 weeks. The trial will be run by King’s College London and Guy’s and St Thomas’ NHS Trust, and last for 2 years.
  We will assess how willing individuals are to participate in the trial, how well they take the medication throughout the trial, and the overall acceptability of the treatment from the perspective of both people with PPP and healthcare professionals. Scoring systems, questionnaires, and in-depth interviews will be used to understand the barriers to running a full-scale clinical trial.

  We will compare the results in this study with a previous trial (APRICOT Trial) in which participants received a non-active (placebo) treatment to determine how many participants will be required for a future full-scale trial. Based on the findings from in-depth interviews with people with PPP and healthcare professionals, changes will be made to the recruitment process throughout the trial, identifying strategies that may improve recruitment in the future.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  24/NE/0147

• Date of REC Opinion

  11 Sep 2024

• REC opinion

  Further Information Favourable Opinion