Adults (18 years and over) with a diagnosis of palmoplantar pustulosis* made by a trained dermatologist with disease of sufficient impact and severity to require systemic therapy Disease duration of ≥6 months, not responding to an adequate trial of topical therapy including very potent corticosteroids Evidence of active pustulation on palms and/or soles At least moderate disease based on a Palmoplantar Pustulosis Investigator Global Assessment Able to give written, informed consent to participate Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
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A history of malignancy of any organ system (other than treated, localised non-melanoma skin cancer), treated or untreated, within the past 5 years A history of provoked or unprovoked venous thromboembolism (deep vein thrombosis or pulmonary embolism), unless actively treated with long-term anticoagulation Previous systemic treatment with a JAK inhibitor A history of recurrent bacterial, fungal or viral infections which, in the opinion of the principal investigator, present a risk to the patient Evidence of active infection or untreated latent tuberculosis HIV positive Active or untreated Hepatitis B or C Use of therapies with potential or known efficacy in psoriasis during or within the specified timeframe before treatment initiation as listed in the washout section Moderate renal impairment (CrCl < 50 mL/min) Neutropenia (<1.5×109/L) Thrombocytopenia (<150×109/L) Moderate hepatic disease and/or raised hepatic transaminases (ALT/AST) > 2 x upper limit of normal at baseline. Patients who fail this screening criterion may still be considered following review by a hepatologist and confirmed expert opinion that study entry is clinically appropriate. Live vaccinations within 3 months prior to the start of study medication, and no planned live vaccinations during the trial and up to 3 months following last dose Women who are pregnant, breast feeding or of childbearing potential not on adequate contraception Male participants who are not willing to use highly effective methods of contraception when engaging in sexual activity with a female of childbearing potential Any condition where, in the opinion of the investigator, the investigational medical product would present risk to the patient. Unable to give written, informed consent. Unable to comply with the study visit schedule Known hypersensitivity to upadacitinib and/or its excipients (SmPC 6.1) -
Receipt of any of the following within the specified timeframe before treatment initiation (baseline, visit 1):
Topical treatments likely to impact signs and symptoms of psoriasis (eg, potent/very potent corticosteroids, vitamin D analogues, calcineurin inhibitors) within 2 weeks Systemic immunosuppressants (eg, methotrexate, ciclosporin, acitretin) within 4 weeks Phototherapy (UVB TL01, UVB, PUVA, UVA1) within 4 weeks Etanercept or adalimumab within 4 weeks Other biologic therapies (infliximab, certolizumab, ustekinumab, secukinumab, ixekizumab, risankizumab, bimekizumab, brodalumab, tildrakizumab, guselkumab) within 3 months Other investigational drugs within 4 months or five half-lives (whichever is longer) Other immunosuppressant/immunomodulatory therapies including intra-articular steroids within 30 days or five half lives (whichever is longer)
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