Palmoplantar PustulosisPhase 2NCT07013201
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 Phase 2 study testing Delgocitinib cream in people with Palmoplantar Pustulosis, run by LEO Pharma at 40 sites in 5 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palmoplantar Pustulosis
- What is being tested?
- Delgocitinib cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 40 sitesin 5 countries
- Study dates
- 11 Sep 2025to 14 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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).
Who cannot join
- 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:
Show all 34Show fewer
- 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.
Trial locations and contacts
40 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
40 sites in 5 countries
Canada10 sites, 9 recruiting
- Recruiting
LEO Pharma Investigational Site
Calgary, Alberta, T3A 2N1
- Recruiting
LEO Pharma Investigational Site
Edmonton, Alberta, T6W 4V4
- Recruiting
LEO Pharma Investigational Site
Fredericton, New Brunswick, E3B 1G9
- Recruiting
LEO Pharma Investigational Site
Hamilton, Ontario, L8L 3C3
- Completed
LEO Pharma Investigational Site
Hamilton, Ontario, L8N 1Y2
- Recruiting
LEO Pharma Investigational Site
Markham, Ontario, L3P 1X2
- Recruiting
LEO Pharma Investigational Site
Montreal, Quebec, H2X 2V1
- Recruiting
LEO Pharma Investigational Site
Surrey, British Columbia, V3R 6A7
- Recruiting
LEO Pharma Investigational Site
Waterloo, Ontario, N2J 1C4
- Recruiting
LEO Pharma Investigational Site
Winnipeg, Manitoba, R3M 3Z4
Germany10 sites, 10 recruiting
- Recruiting
LEO Pharma Investigational Site
Bad Bentheim, 48455
- Recruiting
LEO Pharma Investigational Site
Dresden, 01097
- Recruiting
LEO Pharma Investigational Site
Göttingen, 37075
- Recruiting
LEO Pharma Investigational Site
Hamburg, 20246
- Recruiting
LEO Pharma Investigational Site
Kiel, 24105
- Recruiting
LEO Pharma Investigational Site
Lübeck, 23562
- Recruiting
LEO Pharma Investigational Site
Manheim, 68167
- Recruiting
LEO Pharma Investigational Site
Münster, 48149
- Recruiting
LEO Pharma Investigational Site
Osnabrück, 49074
- Recruiting
LEO Pharma Investigational Site
Witten, 58453
Poland8 sites, 7 recruiting
- Recruiting
LEO Pharma Investigational Site
Bialystok, 15-879
- Completed
LEO Pharma Investigational Site
Iwonicz-Zdrój, 38-440
- Recruiting
LEO Pharma Investigational Site
Lodz, 90-436
- Recruiting
LEO Pharma Investigational Site
Lublin, 20-011
- Recruiting
LEO Pharma Investigational Site
Rzeszów, 35-055
- Recruiting
LEO Pharma Investigational Site
Warsaw, 02-482
- Recruiting
LEO Pharma Investigational Site
Wroclaw, 50-556
- Recruiting
LEO Pharma Investigational Site
Wroclaw, 50-566
United States7 sites, 7 recruiting
- Recruiting
LEO Pharma Investigational Site
Douglasville, Georgia, 30135
- Recruiting
LEO Pharma Investigational Site
Elmhurst, New York, 11373
- Recruiting
LEO Pharma Investigational Site
Fountain Valley, California, 92708
- Recruiting
LEO Pharma Investigation Site
Mayfield Heights, Ohio, 44124
- Recruiting
LEO Pharma Investigational Site
Philadelphia, Pennsylvania, 19103
- Recruiting
LEO Pharma Investigational Site
Portland, Oregon, 97201
- Recruiting
LEO Pharma Investigational Site
West Bloomfield, Michigan, 48322
United Kingdom5 sites, 5 recruiting
- Recruiting
LEO Pharma Investigational Site
Bristol, BS2 8HW
- Recruiting
LEO Pharma Investigational Site
London, SE1 9RT
- Recruiting
LEO Pharma Investigational Site
Newcastle upon Tyne, NE1 4LP
- Recruiting
LEO Pharma Investigational Site
Salford, M6 8HD
- Recruiting
LEO Pharma Investigational Site
Stourbridge, DY8 4JB
About this study
Official title: 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
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.
- Conditions
- Palmoplantar Pustulosis
- Being tested
- Delgocitinib cream, Vehicle cream
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delgocitinib creamDrug
Topical application
Vehicle creamDrug
Topical application
| Study group | Role | What they receive |
|---|---|---|
| Delgocitinib 20 mg/g | Experimental | Participants with mild to severe PPP will receive 20 mg/g of delgocitinib cream twice a day for 16 weeks. Receives: Drug: Delgocitinib cream |
| Cream Vehicle | Placebo comparator | Participants with mild to severe PPP will receive matching vehicle cream twice a day for 16 weeks. Receives: Drug: Vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving at Least 75% Improvement in PPP Area and Severity Index (PPPASI) Score from Baseline (PPPASI-75) at Week 16
Measured: Baseline to Week 16
Secondary outcomes (26)
Number of Participants with PPP-Physician Global Assessment (PGA) Score of 0 or 1 with at Least a 2-step Improvement from Baseline at Week 16
Measured: Baseline to Week 16
Change in the Overall Number of Fresh Pustules From Baseline to Week 16
Measured: Baseline to Week 16
Number of Participants with a ≥1-point Reduction in PPP-PGA Score From Baseline to Week 16
Measured: Baseline to Week 16
Number of Participants with a ≥2-point Reduction in PPP-PGA Score From Baseline to Week 16
Measured: Baseline to Week 16
Change in PPPASI Score From Baseline to Week 16
Measured: Baseline to Week 16
Percentage Change in PPPASI Score From Baseline to Week 16
Measured: Baseline to Week 16
Number of Participants Achieving PPPASI-50 at Week 16
Measured: Week 16
Number of Participants Achieving PPPASI-90 at Week 16
Measured: Week 16
Change from Baseline to Week 16 in PPP-symptoms assessment (SA) Score
Measured: Baseline to Week 16
Percentage Change in PPP-SA Score from Baseline to Week 16
Measured: Baseline to Week 16
Change from Baseline to Week 16 in PPP-SA Itch Score for the Hands
Measured: Baseline to Week 16
Change from Baseline to Week 16 in PPP-SA Itch Score for the Feet
Measured: Baseline to Week 16
Change from Baseline to Week 16 in PPP-SA Pain Score for the Hands
Measured: Baseline to Week 16
Change from Baseline to Week 16 in PPP-SA Pain Score for the Feet
Measured: Baseline to Week 16
Change in Fresh Pustules at Weeks 1, 2, 4, 8, and 12
Measured: Baseline to Week 12
Number of Fresh Pustules Overall at Weeks 1, 2, 4, 8, 12, and 16
Measured: Baseline to Week 16
Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Measured: Baseline to Week 18
Number of Participants with a ≥4-point Reduction in Dermatology Life Quality Index (DQLI) Score From Baseline to Week 16
Measured: Baseline to Week 16
Change from Baseline to Week 16 in DLQI Score
Measured: Baseline to Week 16
Percentage Change from Baseline to Week 16 in DLQI Score
Measured: Baseline to Week 16
Change from Baseline to Week 16 in PPP-Impact Assessment (IA) Score
Measured: Baseline to Week 16
Percentage Change from Baseline to Week 16 in PPP-IA Score
Measured: Baseline to Week 16
Change in Work Productivity and Activity (WPAI) PPP Absenteeism Score from Baseline to Week 16
Measured: Baseline to Week 16
Change in Work WPAI:PPP Presenteeism Score from Baseline to Week 16
Measured: Baseline to Week 16
Change in WPAI:PPP work Productivity Score from Baseline to Week 16
Measured: Baseline to Week 16
Change in WPAI:PPP Activity Impairment Score from Baseline to Week 16
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start11 Sep 2025
- Primary completion14 Dec 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmoplantar PustulosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013201
- Sponsor's protocol ID
- LP0133-2393
- Other IDs
- 2024-518856-21-00, U1111-1319-5081
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07013201
- Acronym / sponsor ID
- LP0133-2393
- Conditions
- Palmoplantar Pustulosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delgocitinib 20 mg/g | Experimental | Drug: Delgocitinib creamParticipants with mild to severe PPP will receive 20 mg/g of delgocitinib cream twice a day for 16 weeks. |
| Cream Vehicle | Placebo comparator | Drug: Vehicle creamParticipants with mild to severe PPP will receive matching vehicle cream twice a day for 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (34 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delgocitinib creamTopical application | Drug | Delgocitinib 20 mg/g |
| Vehicle creamTopical application | Drug | Cream Vehicle |
Primary outcome
Number of Participants Achieving at Least 75% Improvement in PPP Area and Severity Index (PPPASI) Score from Baseline (PPPASI-75) at Week 16
Time frame: Baseline to Week 16
26 secondary outcomes
Number of Participants with PPP-Physician Global Assessment (PGA) Score of 0 or 1 with at Least a 2-step Improvement from Baseline at Week 16
Time frame: Baseline to Week 16
Change in the Overall Number of Fresh Pustules From Baseline to Week 16
Time frame: Baseline to Week 16
Number of Participants with a ≥1-point Reduction in PPP-PGA Score From Baseline to Week 16
Time frame: Baseline to Week 16
Number of Participants with a ≥2-point Reduction in PPP-PGA Score From Baseline to Week 16
Time frame: Baseline to Week 16
Change in PPPASI Score From Baseline to Week 16
Time frame: Baseline to Week 16
Percentage Change in PPPASI Score From Baseline to Week 16
Time frame: Baseline to Week 16
Number of Participants Achieving PPPASI-50 at Week 16
Time frame: Week 16
Number of Participants Achieving PPPASI-90 at Week 16
Time frame: Week 16
Change from Baseline to Week 16 in PPP-symptoms assessment (SA) Score
Time frame: Baseline to Week 16
Percentage Change in PPP-SA Score from Baseline to Week 16
Time frame: Baseline to Week 16
Change from Baseline to Week 16 in PPP-SA Itch Score for the Hands
Time frame: Baseline to Week 16
Change from Baseline to Week 16 in PPP-SA Itch Score for the Feet
Time frame: Baseline to Week 16
Change from Baseline to Week 16 in PPP-SA Pain Score for the Hands
Time frame: Baseline to Week 16
Change from Baseline to Week 16 in PPP-SA Pain Score for the Feet
Time frame: Baseline to Week 16
Change in Fresh Pustules at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline to Week 12
Number of Fresh Pustules Overall at Weeks 1, 2, 4, 8, 12, and 16
Time frame: Baseline to Week 16
Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline to Week 18
Number of Participants with a ≥4-point Reduction in Dermatology Life Quality Index (DQLI) Score From Baseline to Week 16
Time frame: Baseline to Week 16
Change from Baseline to Week 16 in DLQI Score
Time frame: Baseline to Week 16
Percentage Change from Baseline to Week 16 in DLQI Score
Time frame: Baseline to Week 16
Change from Baseline to Week 16 in PPP-Impact Assessment (IA) Score
Time frame: Baseline to Week 16
Percentage Change from Baseline to Week 16 in PPP-IA Score
Time frame: Baseline to Week 16
Change in Work Productivity and Activity (WPAI) PPP Absenteeism Score from Baseline to Week 16
Time frame: Baseline to Week 16
Change in Work WPAI:PPP Presenteeism Score from Baseline to Week 16
Time frame: Baseline to Week 16
Change in WPAI:PPP work Productivity Score from Baseline to Week 16
Time frame: Baseline to Week 16
Change in WPAI:PPP Activity Impairment Score from Baseline to Week 16
Time frame: Baseline to Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Palmoplantar Pustulosis
Not yet recruitingPhase 2
A Trial Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Palmoplantar Pustulosis
Palmoplantar Pustulosis of Adults
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
Active, not recruitingObservational study
A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis
Psoriasis
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Generalized Pustular Psoriasis, Erythrodermic Psoriasis
Active, not recruitingPhase 2
Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study
Generalized Pustular Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Expert study director
LEO Pharma
40 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Delgocitinib cream in people with Palmoplantar Pustulosis, run by LEO Pharma at 40 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Canada, Germany, Poland, United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Disclosure ((+45) 4494 5888, disclosure@leo-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Achieving at Least 75% Improvement in PPP Area and Severity Index (PPPASI) Score from Baseline (PPPASI-75) at Week 16 (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.