{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:37:11Z","timestamp":1787017031495,"version":"build-2736575974"},"reference-count":44,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T00:00:00Z","timestamp":1755734400000},"content-version":"unspecified","delay-in-days":20,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Centre for Translational Medicine, King\u2019s Health Partners"},{"DOI":"10.13039\/501100000272","name":"NIHR","doi-asserted-by":"crossref","award":["NIHR302258"],"award-info":[{"award-number":["NIHR302258"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000272","name":"NIHR","doi-asserted-by":"crossref","award":["NIHR303264"],"award-info":[{"award-number":["NIHR303264"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000272","name":"NIHR","doi-asserted-by":"crossref","award":["Senior Investigator Award"],"award-info":[{"award-number":["Senior Investigator Award"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,7,11]]},"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Palmoplantar pustulosis (PPP) is a rare, debilitating inflammatory skin disease involving painful pustules on the palms and soles. Janus kinase (JAK) inhibitors target pathways relevant to PPP disease biology but also confer a risk of major adverse cardiovascular events and malignancy in certain \u2018at risk\u2019 individuals; this includes those with PPP given prevalent smoking and cardiovascular risk factors in the PPP population. The feasibility of JAK inhibitor therapy for PPP requires assessment prior to a randomised controlled trial evaluation of drug efficacy and safety for this indication.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      The \u2018Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility\u2019 trial is an open-label, single-centre, single-arm, mixed-methods feasibility trial of JAK inhibition in PPP (REC reference: 24\/NE\/0147;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"61751241\">ISRCTN61751241<\/jats:ext-link>\n                      ). Participants (n=20) will receive 8 weeks of treatment with the JAK inhibitor upadacitinib (\u2018Rinvoq\u2019, 30\u2009mg, once daily). Qualitative semistructured interviews (up to n=40) will be undertaken with trial participants, trial decliners and healthcare professionals. The primary outcome will be a composite assessment of feasibility across three domains: recruitment, adherence and acceptability, using a mixed-methods analysis approach. Secondary objectives include the identification of trial recruitment optimisation strategies, using the \u2018Quintet Recruitment Intervention\u2019, and the generation of an indication of effect size on disease severity (measured using the Palmoplantar Pustulosis Psoriasis Area and Severity Index) to inform future sample size calculations. Historic placebo control data from the Anakinra for Pustular Psoriasis: Response in a Controlled Trial (National Institute of Health and Social Care reference: 13\/50\/17; Research Ethics Commitee reference: 16\/LO\/0436) will be used as the effect size comparator. Study recruitment will be undertaken over a 24-month period, commencing in November 2024.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study has been approved by the Newcastle North Tyneside 2 Research Ethics Committee, 24\/NE\/0132. Our findings will inform the feasibility of a future adequately powered RCT evaluating the efficacy of JAK inhibitor therapy in PPP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"ISRCTN61751241\">ISRCTN61751241<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-106361","type":"journal-article","created":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T09:20:53Z","timestamp":1755768053000},"page":"e106361","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility (JAKPPPOT) trial protocol"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"isrctn61751241","registry":"10.18810\/isrctn"},{"clinical-trial-number":"isrctn61751241","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7355-9281","authenticated-orcid":false,"given":"David","family":"Gleeson","sequence":"first","affiliation":[{"name":"St. John's Institute of Dermatology, Guy's & St. Thomas' NHS Foundation Trust and King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7612-1605","authenticated-orcid":false,"given":"Sarah","family":"Chapman","sequence":"additional","affiliation":[{"name":"Centre for Adherence Research and Education, King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"McAteer","sequence":"additional","affiliation":[{"name":"Psoriasis Association, Northampton, Northamptonshire, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"April","family":"Qin","sequence":"additional","affiliation":[{"name":"St. John's Institute of Dermatology, Guy's & St. Thomas' NHS Foundation Trust and King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Gregory","sequence":"additional","affiliation":[{"name":"St. John's Institute of Dermatology, Guy's & St. Thomas' NHS Foundation Trust and King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jade","family":"Pizzato","sequence":"additional","affiliation":[{"name":"St. John's Institute of Dermatology, Guy's & St. Thomas' NHS Foundation Trust and King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kingsley","family":"Powell","sequence":"additional","affiliation":[{"name":"St. John's Institute of Dermatology, Guy's & St. Thomas' NHS Foundation Trust and King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manpreet K","family":"Sagoo","sequence":"additional","affiliation":[{"name":"St. John's Institute of Dermatology, Guy's & St. Thomas' NHS Foundation Trust and King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8983-0355","authenticated-orcid":false,"given":"Weiyu","family":"Ye","sequence":"additional","affiliation":[{"name":"St. John's Institute of Dermatology, Guy's & St. Thomas' NHS Foundation Trust and King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann","family":"Naylor","sequence":"additional","affiliation":[{"name":"Patient and Public Involvement Advisory Group, JAKPPPOT Trial, King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucy","family":"Moorhead","sequence":"additional","affiliation":[{"name":"St. John's Institute of Dermatology, Guy's & St. Thomas' NHS Foundation Trust and King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew E","family":"Pink","sequence":"additional","affiliation":[{"name":"St. John's Institute of Dermatology, Guy's & St. Thomas' NHS Foundation Trust and King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Woolf","sequence":"additional","affiliation":[{"name":"St. John's Institute of Dermatology, Guy's & St. Thomas' NHS Foundation Trust and King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Barker","sequence":"additional","affiliation":[{"name":"St. John's Institute of Dermatology, Guy's & St. Thomas' NHS Foundation 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