Testing Delgocitinib cream with Vehicle cream against a placebo for palmoplantar pustulosis

Exclusion

• −Known or suspected hypersensitivity to any component(s) of the IMP.
• −Systemic treatment within 4 weeks prior to baselineBaselineYour starting measurements, taken before treatment begins.Read more → with immunosuppressive drugs (e.g., methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g., acitretin), tyrosine kinase inhibitors, phosphodiesterase-4 inhibitors, or corticosteroids (steroid eye drops and inhaled or intranasal steroids in the doses recommended in the product prescribing information for the treatment of allergic conjunctivitis, asthma, or rhinitis are allowed).
• −Positive hepatitis B surface antigen and/or hepatitis B core antibody and positive hepatitis B virus DNA (participants who have tested positive for hepatitis B core antibody are eligible if tests for hepatitis B surface antigen and hepatitis B virus DNA are negative) or positive hepatitis C virus antibody serology confirmed by hepatitis C virus RNA at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
• −Presence or known history of drug-induced PPP (e.g., a new onset of PPP or an exacerbation of PPP from beta blockers, calcium channel blockers, lithium, or biologic therapy including infliximab, adalimumab, or etanercept).
• −Presence of acrodermatitis continua of Hallopeau.
• −Active dermatologic condition that could confound the diagnosis of PPP or interfere with assessment of the IMP, as assessed by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
• −Clinically significant infection on the palms or soles.
• −Concurrent plaque psoriasis covering \>5% of body surface area.
• −Clinically significant infection within 4 weeks prior to baseline, which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the IMP, or reduce the participant's ability to participate in the trial. Clinically significant infections are defined as:
• −A systemic infection.
• −A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
• −History of any known primary immunodeficiency disorder, including a positive human immunodeficiency virus test at screening, or the participant taking antiretroviral medications as determined by medical history and/or the participant's verbal report.
• −Any documented active or suspected malignancy, or history of malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix appropriately treated before the baseline visit.
• −Any disorder that is not stable and could:
• −Affect the safety of the participant throughout the trial.
• −Impede the participant's ability to complete the trial. Examples include, but are not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, and psychiatric disorders, as well as major physical impairment.
• −Any clinically significant abnormal finding occurring during the screening period and/or observed at the baseline visit that may put the participant at risk due to their participation in the trial or could influence the participant's ability to complete the trial.
• −Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator.
• −Use of tanning beds or phototherapy (e.g., ultraviolet B \[UVB\], ultraviolet A1 \[UVA1\], psoralen ultraviolet A \[PUVA\]) on the palms or soles within 4 weeks prior to baseline.
• −Use of systemic or topical janus kinase inhibitors (including delgocitinib/LEO 124249) within 4 weeks prior to baseline.
• −Cutaneously applied treatment with immunomodulators (e.g., phosphodiesterase-4 \[PDE-4\] inhibitors, pimecrolimus, tacrolimus, tapinarof, vitamin D3 derivatives) or TCS on the palms or soles within 2 weeks prior to baseline.
• −Use of systemic antibiotics or cutaneously applied antibiotics on the palms or soles within 2 weeks prior to baseline.
• −Other transdermal or cutaneously applied therapy on the palms or soles (except for the use of the participant's own non-medicated emollients) within 1 week prior to baseline.
• −Cutaneously applied treatments in regions other than the palms or soles, which could interfere with clinical trialInterventional studyA study where participants are given something to see what happens.Read more → evaluations or pose a safety concern (excluding treatments for psoriasis patches or other non-exclusionary skin conditions, if needed) within 1 week prior to baseline.
• −Treatment with any marketed biological therapy or investigational biologic agents:
• −Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
• −Other biologics, including but not limited to secukinumab, ustekinumab, tildrakizumab, ixekizumab, risankizumab, guselkumab, and tumour necrosis factor (TNF)-alpha inhibitors: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
• −Treatment with any non-marketed drug substance (i.e., an agent that has not yet been made available for clinical use following registration) within the last 4 weeks prior to baseline or 5 half-lives, whichever is longer.
• −Current participation in any other interventional clinical trial.
• −Previously randomisedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → in this clinical trial.
• −Previously randomised in a clinical trial with delgocitinib.
• −Employees of the trial siteTrial siteA hospital or clinic where a study is actually run.Read more →, or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals.
• −Women who are pregnant or lactating.
• −Major surgery within 8 weeks prior to screening or planned in-patient surgery or hospitalisation during the trial period.