NCT07013201|RecruitingPhase 2FDA Drug

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

LEO Pharma ClinicalTrials.gov

Compare

3 other identifiers

LP0133-23932024-518856-21-00U1111-1319-5081

Study Type

interventional

Target

135

Locations

5 countries

Sites

Timeline

RegisteredJun 2025

StartedSep 2025

CompletionDec 2026

Brief 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). Total study duration for each participants will be approximately 18 weeks, for an approximate total of 9 visits.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

135

participants targeted

Target at P75+ for phase_2

Timeline

7mo left

Started Sep 2025

Shorter than P25 for phase_2

Geographic Reach

5 countries

36 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Progress52%

Sep 2025Dec 2026

First Submitted

Initial submission to the registry

June 2, 2025

Completed

8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed

3 months until next milestone

Study Start

First participant enrolled

September 11, 2025

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2026

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

June 2, 2025

Last Update Submit

March 13, 2026

Conditions

Palmoplantar Pustulosis

Outcome Measures

Primary Outcomes (1)

Number of Participants Achieving at Least 75% Improvement in PPP Area and Severity Index (PPPASI) Score from Baseline (PPPASI-75) at Week 16
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
Baseline to Week 16
Change in the Overall Number of Fresh Pustules From Baseline to Week 16
Baseline to Week 16
Number of Participants with a ≥1-point Reduction in PPP-PGA Score From Baseline to Week 16
Baseline to Week 16
Number of Participants with a ≥2-point Reduction in PPP-PGA Score From Baseline to Week 16
Baseline to Week 16
Change in PPPASI Score From Baseline to Week 16
Baseline to Week 16
+21 more secondary outcomes

Study Arms (2)

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.

Drug: Delgocitinib cream

Cream Vehicle

PLACEBO COMPARATOR

Participants with mild to severe PPP will receive matching vehicle cream twice a day for 16 weeks.

Drug: Vehicle cream

Interventions

Delgocitinib creamDRUG

Topical application

Delgocitinib 20 mg/g

Vehicle creamDRUG

Topical application

Cream Vehicle

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

You may not qualify if:

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.
+18 more criteria

Contact the study team to confirm eligibility.