A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis
A Proof-of-concept Phase 2a, Double-blind, 2-arm Trial to Investigate the Efficacy and Safety of Twice Daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle During a 16-week Treatment Period in Adult Subjects With Mild to Severe Palmoplantar Pustulosis
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 9 visits
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Total study duration for each participants will be approximately 18 weeks, for an approximate total of 9 visits."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well delgocitinib cream 20 mg/g works and how safe it is compared with a cream without the study drug. It is for adults with mild to severe palmoplantar pustulosis (PPP), which causes pus-filled bumps on the palms or soles. The cream is used twice a day for 16 weeks, with about 9 visits over about 18 weeks total.
The main objective of the study is to evaluate the efficacy of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult participants with mild to severe palmoplantar pustulosis (PPP). Total study duration for each participants will be approximately 18 weeks, for an approximate total of 9 visits.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 years old and sign a consent form before any study procedures.
- Be able to follow study instructions and attend clinic visits.
- Have PPP for more than 6 months, with lasting pus-filled bumps not caused by infection on the palms or soles.
- Have PPP confirmed by a central review of photos taken at screening.
- Have at least mild PPP and meet the required skin severity scores at screening and the starting visit.
- Have at least 5 fresh, clearly outlined white or yellow pus-filled bumps at both visits.
- Have tried steroid creams without enough benefit, or have a study doctor decide these creams are not suitable.
- If you can become pregnant, use an accepted form of birth control throughout the study until the last dose.
Who can't join
- Have PPP caused or worsened by medicines; a condition called acrodermatitis continua of Hallopeau, which causes pus-filled bumps near nails; another skin condition that affects study checks; or plaque psoriasis covering more than 5% of your body.
- Have a major infection on the palms or soles, or a serious infection within 4 weeks before the starting visit. Certain immune system disorders, HIV, use of HIV medicines, or positive hepatitis B or C tests may also rule you out.
- Have an unstable illness or abnormal test result that makes joining unsafe or hard to complete. Major surgery within 8 weeks before screening, or planned hospital surgery or a hospital stay during the study, also rules you out.
- Have known or suspected cancer, or cancer within the past 5 years, except certain skin cancers or very early cervical cancer properly treated before the starting visit.
- Be pregnant or breastfeeding, have a known or suspected allergy to a study cream ingredient, or have current or recent long-term alcohol or drug misuse or another condition that makes following study instructions difficult.
- Have used certain medicines, skin treatments, antibiotics, tanning beds, or light treatments too recently. Waiting periods vary by treatment, from 1 week to 6 months or longer; plain, non-medicated moisturizers are allowed.
- Be in another treatment study now, or have previously been assigned to treatment in this study or any delgocitinib study.
- Work at the study site, help plan or run the study, or be an immediate family member of someone who does.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Signed and dated informed consent has been obtained prior to any protocol-related procedures. * Age 18 years or above at the time of informed consent signing. * Participant is able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator. * Diagnosis of PPP in accordance with the consensus diagnostic criteria established by European Rare and Severe Psoriasis Expert Network: primary, persistent (\>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, with or without plaque psoriasis elsewhere on the body. * Confirmed PPP by central evaluation of photographs taken at screening. * Mild to severe PPP current condition defined by: * Disease duration of PPP of \>6 months before randomisation. * PPP-PGA of at least mild severity (PPP-PGA ≥2) at screening and baseline. * PPPASI ≥8 at screening and baseline. * Presence of ≥5 well-demarcated fresh pustules (white or yellow pustules) in total across all affected areas at screening and baseline. * Participants with prior experiences of inadequate response with topical corticosteroid(s) (TCS) or for whom TCS are inadvisable, as judged by the investigators. * A woman of childbearing potential must use an acceptable form of birth control throughout the trial up until the last administration of investigational medicinal product (IMP). Exclusion Criteria: * 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 investigator. * 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. * Major surgery within 8 weeks prior to screening or planned in-patient surgery or hospitalisation during the trial period. * 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. * 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 screening. * Known or suspected hypersensitivity to any component(s) of the IMP. * Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator. * Women who are pregnant or lactating. * Systemic treatment within 4 weeks prior to baseline 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). * 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 trial 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 randomised in this clinical trial. * Previously randomised in a clinical trial with delgocitinib. * Employees of the trial site, or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals.
Study sites (7)
CA
- LEO Pharma Investigational Site · Fountain Valley, CA 92708More trials in Fountain Valley
GA
- LEO Pharma Investigational Site · Douglasville, GA 30135More trials in Douglasville
MI
- LEO Pharma Investigational Site · West Bloomfield, MI 48322More trials in West Bloomfield
NY
- LEO Pharma Investigational Site · Elmhurst, NY 11373More trials in Elmhurst
OH
- LEO Pharma Investigation Site · Mayfield Heights, OH 44124More trials in Mayfield Heights
OR
- LEO Pharma Investigational Site · Portland, OR 97201More trials in Portland
PA
- LEO Pharma Investigational Site · Philadelphia, PA 19103More trials in Philadelphia