Phase 2 Psoriasis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have signed and dated a consent form before any trial-related procedures begin.
• People aged 18 or older at the time of signing the consent form.
• People who, in the investigator's assessment, are able to attend clinic visits and follow the trial's requirements.
• People who have been diagnosed with palmoplantar pustulosis (PPP) — a skin condition causing pustules on the palms and/or soles lasting more than 3 months — based on recognised European expert diagnostic guidelines.
• People whose PPP diagnosis has been confirmed through central review of photographs taken at screening.
• People whose PPP has been present for more than 6 months before the randomisation point, with a condition rated at least "mild" on two specific severity scales (PPP-PGA and PPPASI) at both screening and baseline.
• People who have at least 5 clearly defined fresh pustules (white or yellow) across all affected areas at both screening and baseline.
• People who have previously tried steroid creams or ointments (topical corticosteroids) without adequate results, or for whom those treatments are considered unsuitable by the investigator.
• Women who could become pregnant must use an acceptable form of contraception throughout the trial, up to the last dose of the trial medication.

Who may not be able to join:

• People whose PPP is known or believed to have been caused or worsened by certain medications, such as beta blockers, calcium channel blockers, lithium, or certain biologic therapies (for example, infliximab, adalimumab, or etanercept).
• People who have a related skin condition called acrodermatitis continua of Hallopeau.
• People who have another active skin condition that could make it difficult to assess the PPP or the trial medication, as determined by the investigator.
• People who have a significant active infection on the palms or soles.
• People who have plaque psoriasis covering more than 5% of their body surface area at the same time.
• People who have had a significant infection in the 4 weeks before the baseline visit — such as a body-wide (systemic) infection, or a serious skin infection requiring injected or intravenous antibiotics, antiviral, or antifungal medication — that the investigator considers a safety concern or that could affect trial results.
• People who have a known primary immune deficiency disorder, a positive HIV test at screening, or who are taking antiretroviral (HIV) medications.
• People who have had major surgery within 8 weeks before screening, or who have planned surgery or a hospital stay during the trial period.
• People who have an active or suspected cancer, or a history of cancer within the past 5 years — with some exceptions for certain types of treated skin cancers (such as basal cell carcinoma, localised squamous cell carcinoma, or cervical carcinoma in situ) that were appropriately treated before the baseline visit.
• People who have an unstable medical condition — such as a heart, liver, kidney, neurological, psychiatric, or other significant disorder — that could affect their safety or ability to complete the trial.
• People who have any clinically significant abnormal finding during screening or at the baseline visit that could put them at risk or affect their ability to complete the trial.
• People who test positive for hepatitis B surface antigen and/or certain hepatitis B markers, or for hepatitis C virus, in specific combinations as defined by the trial criteria (confirm with trial site for the exact testing requirements).
• People who are known or suspected to be allergic to any component of the trial medication.
• People with a current or recent history of significant alcohol or drug misuse, or any condition the investigator considers likely to affect trial compliance.
• Women who are pregnant or breastfeeding.
• People who have taken certain systemic (whole-body) medications within 4 weeks before the baseline visit, including immunosuppressants (such as methotrexate, cyclosporine, or azathioprine), immunomodulating drugs, retinoids (such as acitretin), tyrosine kinase inhibitors, phosphodiesterase-4 inhibitors, or oral/systemic corticosteroids (some exceptions apply for steroid eye drops, inhalers, or nasal sprays used at standard doses for allergies or asthma — confirm with trial site).
• People who have used tanning beds or phototherapy treatments on the palms or soles within 4 weeks before the baseline visit.
• People who have used JAK inhibitor medications — including delgocitinib/LEO 124249 — either as a tablet or applied to the skin, within 4 weeks before the baseline visit.
• People who have applied certain immune-modifying creams or topical steroid treatments to the palms or soles within 2 weeks before the baseline visit (such as PDE-4 inhibitors, pimecrolimus, tacrolimus, tapinarof, or vitamin D3 creams).
• People who have used antibiotic treatments — either taken by mouth or applied to the palms or soles — within 2 weeks before the baseline visit.
• People who have applied any other medicated cream or skin treatment to the palms or soles within 1 week before the baseline visit (plain, non-medicated moisturisers are allowed).
• People who have applied skin treatments to areas other than the palms or soles that could interfere with trial assessments or raise safety concerns within 1 week before the baseline visit (confirm with trial site for exceptions).
• People who have recently received certain biologic therapies: cell-depleting biologics (such as rituximab) within 6 months before baseline, or other biologics (such as secukinumab, ustekinumab, or TNF-alpha inhibitors) within 3 months or 5 half-lives of the drug — whichever is longer — before baseline.
• People who have received an experimental drug (not yet approved for general clinical use) within 4 weeks before baseline, or within 5 half-lives of the drug, whichever is longer.
• People who are currently taking part in another interventional clinical trial.
• People who have previously been enrolled in this specific trial.
• People who have previously been enrolled in a clinical trial involving the drug delgocitinib.
• People who work at the trial site, are directly involved in planning or running the trial, or are immediate family members of such individuals.

Important: Always verify eligibility with the trial site directly before applying.