Palmoplantar PustulosisNCT07000630
Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis
A study testing Deucravacitinib in people with Palmoplantar Pustulosis, run by Peking University First Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to investigate the efficacy and safety of Deucravacitinib in patients with moderate-to-severe palmoplantar pustulosis. Approximately 25 subjects will be included in the study and receive Deucravacitinib 6mg per day for four months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Palmoplantar Pustulosis
- What is being tested?
- Deucravacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between ages 18 - 65 years who have suffered from palmoplantar pustulosis (PPP) for at least 6 months.
- Patients were required to have over 10 well-demarcated white or yellow pustules across all regions, with or without plaque psoriasis
- Patients were required to have a Palmoplantar Pustular Physician's Global Assessment (PPPGA) score of at least moderate severity (≥3) and a minimum PPPASI score of 12.
- Signed and dated written informed consent in accordance with ICH GCP and local legislation prior to admission to the trial.
- Further criteria apply.
Who cannot join
- Systemic treatment for PPP ended less than five half-lives or 12 weeks ago
- Topical treatment for PPP ended less 4 weeks ago
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
- Presence or known history of anti-TNF-induced PPP-like disease.
- Patient with a transplanted organ (with exception of a corneal transplant >12 weeks Prior to screening) or who have ever received stem cell therapy.
- Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
- Further criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis; A Nonrandomized Controlled Trial
The goal of this clinical trial is to investigate the efficacy and safety of Deucravacitinib in patients with moderate-to-severe palmoplantar pustulosis. Approximately 25 subjects will be included in the study and receive Deucravacitinib 6mg per day for four months. This study will begin June 2025 and is expected to last 14 months.
- Conditions
- Palmoplantar Pustulosis
- Being tested
- Deucravacitinib
- Keywords
- Palmoplantar pustulosis, Deucravacitinib
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
25 subjects with palmoplantar pustulosis will be allocated to receive oral Deucravacitinib 6mg everyday for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Deucravacitinib treatment | Experimental | 25 subjects with palmoplantar pustulosis will be allocated to receive oral Deucravacitinib 6mg everyday for 16 weeks. Receives: Drug: Deucravacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint
The primary efficacy endpoint was percentage change from baseline in Palmoplantar Pustular Area and Severity Index (PPPASI) at W16.
Measured: From enrollment to the end of treatment at 16 weeks
Secondary outcomes (2)
Effect of Deucravacitinib on overall severity of palmoplantar pustulosis
Mean change in erythema and pustules from Baseline to week 16 will be evaluated by Palmoplantar Pustular Physician's Global Assessment (PPPGA).
Measured: From enrollment to the end of treatment at 16 weeks
Effect of Deucravacitinib on quality of life: Dermatology Life Quality Index (DLQI)
Mean change in quality of life from Baseline to week 16 will be evaluated by Dermatology Life Quality Index (DLQI)
Measured: From enrollment to the end of treatment at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start20 Jun 2025
- Primary completion30 Nov 2025
- Study completion1 Dec 2025
Why it stopped: Terminated early due to lack of expected efficacy. Three participants were enrolled but none completed the study.
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.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingru Sun, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000630
- Sponsor's protocol ID
- 2024-452
- Status last verified
- Mar 2026
- First submitted
- 24 May 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis; A Nonrandomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07000630
- Acronym / sponsor ID
- 2024-452
- Conditions
- Palmoplantar Pustulosis
- Keywords
- Palmoplantar pustulosis, Deucravacitinib
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early due to lack of expected efficacy. Three participants were enrolled but none completed the study.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 3 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 goal of this clinical trial is to investigate the efficacy and safety of Deucravacitinib in patients with moderate-to-severe palmoplantar pustulosis. Approximately 25 subjects will be included in the study and receive Deucravacitinib 6mg per day for four months. This study will begin June 2025 and is expected to last 14 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deucravacitinib treatment | Experimental | Drug: Deucravacitinib25 subjects with palmoplantar pustulosis will be allocated to receive oral Deucravacitinib 6mg everyday for 16 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women between ages 18 - 65 years who have suffered from palmoplantar pustulosis (PPP) for at least 6 months.
- Patients were required to have over 10 well-demarcated white or yellow pustules across all regions, with or without plaque psoriasis
- Patients were required to have a Palmoplantar Pustular Physician's Global Assessment (PPPGA) score of at least moderate severity (≥3) and a minimum PPPASI score of 12.
- Signed and dated written informed consent in accordance with ICH GCP and local legislation prior to admission to the trial.
- Further criteria apply.
Key exclusion criteria (8 listed)
- Systemic treatment for PPP ended less than five half-lives or 12 weeks ago
- Topical treatment for PPP ended less 4 weeks ago
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
- Presence or known history of anti-TNF-induced PPP-like disease.
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 |
|---|---|---|
| Deucravacitinib25 subjects with palmoplantar pustulosis will be allocated to receive oral Deucravacitinib 6mg everyday for 16 weeks. | Drug | Deucravacitinib treatment |
Primary outcome
Primary efficacy endpoint
Time frame: From enrollment to the end of treatment at 16 weeks
The primary efficacy endpoint was percentage change from baseline in Palmoplantar Pustular Area and Severity Index (PPPASI) at W16.
2 secondary outcomes
Effect of Deucravacitinib on overall severity of palmoplantar pustulosis
Time frame: From enrollment to the end of treatment at 16 weeks
Effect of Deucravacitinib on quality of life: Dermatology Life Quality Index (DLQI)
Time frame: From enrollment to the end of treatment at 16 weeks
Results and safety
The study was stopped early (reason given: Terminated early due to lack of expected efficacy. Three participants were enrolled but none completed the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deucravacitinib in people with Palmoplantar Pustulosis, run by Peking University First Hospital at 1 site in China.
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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated early due to lack of expected efficacy. Three participants were enrolled but none completed the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint (time frame: From enrollment to the end of treatment at 16 weeks). 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 11 Mar 2026.