Palmoplantar Pustulosis (PPP)NCT07270003
A Prospective, Single-arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Ivarmacitinib in the Treatment of Palmoplantar Pustulosis
A study testing Ivarmacitinib in people with Palmoplantar Pustulosis (PPP), run by Xijing Hospital at 1 site in China.
Trial summary
What's the problem? Palmoplantar pustulosis (PPP) is a long-term skin condition that mainly affects the palms of hands and soles of feet. It causes red, scaly skin with small, non-infectious blisters (called pustules), and often brings pain, itching, or even joint damage over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palmoplantar Pustulosis (PPP)
- What is being tested?
- Ivarmacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Oct 2026
- Phase
- Interventional
- 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
- ≥18 years old; clinically/pathologically confirmed PPP; failure/intolerance to ≥1 conventional systemic therapy (12-24 weeks of standard dosing); physician-judged suitability for ivarmacitinib; signed informed consent.
Who cannot join
- Lymphocyte count <0.5×10⁹/L, neutrophils <1×10⁹/L, platelets <100×10⁹/L, or hemoglobin <80g/L; serum creatinine >132.6μmol/L, AST/ALT >2×ULN, or total bilirubin >2.0mg/dL; active infections (tuberculosis, hepatitis B/C, systemic candidiasis); other conditions hindering participation or data interpretation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing hospital
Xi'an, Shaanxi, 710000
Zhongrui Xu, MD, 15102994796, 2770124936@qq.com
About this study
What's the problem? Palmoplantar pustulosis (PPP) is a long-term skin condition that mainly affects the palms of hands and soles of feet. It causes red, scaly skin with small, non-infectious blisters (called pustules), and often brings pain, itching, or even joint damage over time. It's more common in women aged 40-58 and makes daily life harder. Right now, treatments for PPP aren't great. Creams (like corticosteroids) make symptoms come back fast. Pills (such as acitretin) work slowly, don't always help, and can have bad side effects. Some strong injectable drugs (biologics) are expensive, need long-term use, and require regular checks for infections-plus they don't work well for many PPP patients.
What's this study trying to do?
Read more
This study will test a new pill called ivarmacitinib to see if it works for PPP, and if it's safe. Here's what researchers want to find out:
Does ivarmacitinib reduce PPP symptoms (like blisters and redness)-and how quickly? Does it help with joint problems that sometimes come with PPP? Are there side effects (like infections, headaches, or stomach issues)? And how common or serious are they? Do things like a patient's age, past treatments, or other health issues affect how well ivarmacitinib works? How will the study work? This is a open study (everyone knows they're taking ivarmacitinib) with 60 patients at the First Affiliated Hospital of Air Force Medical University (China).
Who can join? Must be 18 or older, with a confirmed PPP diagnosis. Tried at least one other standard treatment (like pills or creams) that didn't work or caused too many side effects.
Must not have serious health issues like active infections (e.g., tuberculosis, hepatitis), low blood cell counts, or bad liver/kidney problems.
What will patients do? Take one 4mg ivarmacitinib pill every day for 12 weeks. Can't use other drugs or light therapy for PPP during this time (but simple moisturizers or meds for other health issues are okay).
Before the study starts: Doctors will check basic health (age, weight, lifestyle), PPP symptoms, and do blood tests, urine tests, and a chest X-ray.
During the study (Weeks 1, 2, 4, 8, 12): Doctors will check how symptoms are changing, ask if patients have any side effects, and do another round of blood tests at Week 12.
What will researchers look for? Does it work? The main goal is to see how many patients have a 50% or bigger reduction in PPP symptoms by Week 12. They'll also check if symptoms get 75% or 90% better, if joints feel better, and if daily life (like working or sleeping) improves.
Is it safe? Researchers will track all side effects-especially infections, blood clots, stomach aches, or headaches-and how serious they are.
- Conditions
- Palmoplantar Pustulosis (PPP)
- Being tested
- Ivarmacitinib
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvarmacitinibDrug
Oral ivarmacitinib 4mg once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Oral ivarmacitinib 4mg once daily for 12 weeks | Other | Not described Receives: Drug: Ivarmacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPPASI50 response rate (≥50% reduction in PPPASI score)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmoplantar Pustulosis (PPP)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270003
- Sponsor's protocol ID
- KY20252406-C-1
- Status last verified
- Sep 2025
- First submitted
- 26 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Ivarmacitinib in the Treatment of Palmoplantar Pustulosis
- ClinicalTrials.gov ID
- NCT07270003
- Acronym / sponsor ID
- KY20252406-C-1
- Conditions
- Palmoplantar Pustulosis (PPP)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 8 Dec 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.
What's the problem? Palmoplantar pustulosis (PPP) is a long-term skin condition that mainly affects the palms of hands and soles of feet. It causes red, scaly skin with small, non-infectious blisters (called pustules), and often brings pain, itching, or even joint damage over time. It's more common in women aged 40-58 and makes daily life harder. Right now, treatments for PPP aren't great. Creams (like corticosteroids) make symptoms come back fast. Pills (such as acitretin) work slowly, don't always help, and can have bad side effects. Some strong injectable drugs (biologics) are expensive, need long-term use, and require regular checks for infections-plus they don't work well for many PPP patients.
What's this study trying to do?
This study will test a new pill called ivarmacitinib to see if it works for PPP, and if it's safe. Here's what researchers want to find out:
Does ivarmacitinib reduce PPP symptoms (like blisters and redness)-and how quickly? Does it help with joint problems that sometimes come with PPP? Are there side effects (like infections, headaches, or stomach issues)? And how common or serious are they? Do things like a patient's age, past treatments, or other health issues affect how well ivarmacitinib works? How will the study work? This is a open study (everyone knows they're taking ivarmacitinib) with 60 patients at the First Affiliated Hospital of Air Force Medical University (China).
Who can join? Must be 18 or older, with a confirmed PPP diagnosis. Tried at least one other standard treatment (like pills or creams) that didn't work or caused too many side effects.
Must not have serious health issues like active infections (e.g., tuberculosis, hepatitis), low blood cell counts, or bad liver/kidney problems.
What will patients do? Take one 4mg ivarmacitinib pill every day for 12 weeks. Can't use other drugs or light therapy for PPP during this time (but simple moisturizers or meds for other health issues are okay).
Before the study starts: Doctors will check basic health (age, weight, lifestyle), PPP symptoms, and do blood tests, urine tests, and a chest X-ray.
During the study (Weeks 1, 2, 4, 8, 12): Doctors will check how symptoms are changing, ask if patients have any side effects, and do another round of blood tests at Week 12.
What will researchers look for? Does it work? The main goal is to see how many patients have a 50% or bigger reduction in PPP symptoms by Week 12. They'll also check if symptoms get 75% or 90% better, if joints feel better, and if daily life (like working or sleeping) improves.
Is it safe? Researchers will track all side effects-especially infections, blood clots, stomach aches, or headaches-and how serious they are.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral ivarmacitinib 4mg once daily for 12 weeks | Other | Drug: Ivarmacitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥18 years old; clinically/pathologically confirmed PPP; failure/intolerance to ≥1 conventional systemic therapy (12-24 weeks of standard dosing); physician-judged suitability for ivarmacitinib; signed informed consent.
Key exclusion criteria (1 listed)
- Lymphocyte count <0.5×10⁹/L, neutrophils <1×10⁹/L, platelets <100×10⁹/L, or hemoglobin <80g/L; serum creatinine >132.6μmol/L, AST/ALT >2×ULN, or total bilirubin >2.0mg/dL; active infections (tuberculosis, hepatitis B/C, systemic candidiasis); other conditions hindering participation or data interpretation.
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 |
|---|---|---|
| IvarmacitinibOral ivarmacitinib 4mg once daily for 12 weeks | Drug | Oral ivarmacitinib 4mg once daily for 12 weeks |
Primary outcome
PPPASI50 response rate (≥50% reduction in PPPASI score)
Time frame: Week 12
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 8 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Palmoplantar Pustulosis (PPP)
Not yet recruitingPhase 3
Tofacitinib Plus Imatinib in Moderate-to-Severe Palmoplantar Pustulosis
Palmoplantar Pustulosis (PPP)
RecruitingPhase 4
Clinical Observation of Xeligekimab in the Treatment of Moderate to Severe Palmoplantar Pustulosis
Palmoplantar Pustulosis (PPP)
Not yet recruitingObservational study
Construction of a Psoriasis and Psoriatic Arthritis Diagnostic Model Based on Multidimensional Nail Information
Psoriasis (PsO), Psoriatic Arthritis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ivarmacitinib in people with Palmoplantar Pustulosis (PPP), run by Xijing 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 1 inclusion and 1 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 8 Dec 2025. 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?
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 Gang Wang, Phd (15102994796, xjwgang@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPPASI50 response rate (≥50% reduction in PPPASI score) (time frame: Week 12). 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 8 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.