Palmoplantar PustulosisNCT07552454
Picankibart in Palmoplantar Pustulosis
A study testing Picankibart in people with Palmoplantar Pustulosis, run by Xijing Hospital at 1 site in China.
Trial summary
1. Study Design This study is designed as a prospective, single-arm, open-label clinical study. It will be conducted by the Department of Dermatology, the First Affiliated Hospital of Air Force Medical University, and plans to enroll 60 eligible subjects. 2. Study Subjects Inclusion Criteria 1. 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?
- Picankibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2026to 31 Dec 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years, regardless of gender. Patients with a confirmed diagnosis of palmoplantar pustulosis based on clinical manifestations and/or skin histopathology.
- Failed treatment with at least one conventional systemic agent (regular administration at standard dosage for 12-24 weeks), or intolerant to adverse reactions.
- Considered suitable for treatment with picankibart as assessed by the clinician.
- Voluntarily participate in the study and provide written informed consent.
Who cannot join
- Patients with active hepatitis B, hepatitis C, or tuberculosis. Pregnant patients or those planning pregnancy within 6 months. Subjects unable to comply with follow-up as required by the study protocol. Other conditions deemed unsuitable for this study.
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
Department of Dermatology, Xijing Hospital, Fourth Military Medical University, No. 127 of West Changle Road, 710032, Xi'an, Shaanxi, China
Xi'an, Shaanxi, 710032
Shuai Shao, MD PhD, 8619249282690, 2269744794@qq.com
About this study
Official title: Efficacy and Safety of Picankibart in the Treatment of Moderate-to-Severe Palmoplantar Pustulosis: A Prospective, Single-Arm, Open-Label Clinical Study
- Study Design This study is designed as a prospective, single-arm, open-label clinical study. It will be conducted by the Department of Dermatology, the First Affiliated Hospital of Air Force Medical University, and plans to enroll 60 eligible subjects.
- Study Subjects
Inclusion Criteria
Read more
- Aged 18-65 years, regardless of gender.
- Patients with a confirmed diagnosis of palmoplantar pustulosis based on clinical manifestations and/or skin histopathology.
- Failed treatment with at least one conventional systemic agent (regular administration at standard dosage for 12-24 weeks), or intolerant to adverse reactions.
- Considered suitable for treatment with Picankibart as assessed by the clinician.
- Voluntarily participate in the study and provide written informed consent.
Exclusion Criteria
- Patients with active hepatitis B, hepatitis C, or tuberculosis.
- Pregnant patients or those planning pregnancy within 6 months.
- Subjects unable to comply with follow-up as required by the study protocol.
- Other conditions deemed unsuitable for this study.
Withdrawal Criteria
- Subjects may withdraw from the study at any time for any reason.
- Occurrence of a serious adverse event or intolerable adverse event.
- Development of any item listed in the exclusion criteria during the study.
- The investigator may decide subject withdrawal for medical reasons.
- Conditions
- Palmoplantar Pustulosis
- Being tested
- Picankibart
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicankibartDrug
Induction phase: Picankibart 200 mg administered subcutaneously at Weeks 0, 4, and 8.
Maintenance phase: Picankibart 100 mg administered subcutaneously at Weeks 20, 32, and 44.
| Study group | Role | What they receive |
|---|---|---|
| Picankibart in Palmoplantar Pustulosis | Experimental | Not described Receives: Drug: Picankibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)
Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)
Measured: 16 Week
Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)
Measured: 16 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion31 Dec 2027 (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.
- More trials run by Xijing 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
- Non-randomised
- 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
- NCT07552454
- Sponsor's protocol ID
- KY20262056-F-1
- Status last verified
- Mar 2026
- First submitted
- 20 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Picankibart in the Treatment of Moderate-to-Severe Palmoplantar Pustulosis: A Prospective, Single-Arm, Open-Label Clinical Study
- ClinicalTrials.gov ID
- NCT07552454
- Acronym / sponsor ID
- KY20262056-F-1
- Conditions
- Palmoplantar Pustulosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Apr 2026 (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.
- Study Design This study is designed as a prospective, single-arm, open-label clinical study. It will be conducted by the Department of Dermatology, the First Affiliated Hospital of Air Force Medical University, and plans to enroll 60 eligible subjects.
- Study Subjects
Inclusion Criteria
- Aged 18-65 years, regardless of gender.
- Patients with a confirmed diagnosis of palmoplantar pustulosis based on clinical manifestations and/or skin histopathology.
- Failed treatment with at least one conventional systemic agent (regular administration at standard dosage for 12-24 weeks), or intolerant to adverse reactions.
- Considered suitable for treatment with Picankibart as assessed by the clinician.
- Voluntarily participate in the study and provide written informed consent.
Exclusion Criteria
- Patients with active hepatitis B, hepatitis C, or tuberculosis.
- Pregnant patients or those planning pregnancy within 6 months.
- Subjects unable to comply with follow-up as required by the study protocol.
- Other conditions deemed unsuitable for this study.
Withdrawal Criteria
- Subjects may withdraw from the study at any time for any reason.
- Occurrence of a serious adverse event or intolerable adverse event.
- Development of any item listed in the exclusion criteria during the study.
- The investigator may decide subject withdrawal for medical reasons.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Picankibart in Palmoplantar Pustulosis | Experimental | Drug: Picankibart |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65 years, regardless of gender. Patients with a confirmed diagnosis of palmoplantar pustulosis based on clinical manifestations and/or skin histopathology.
- Failed treatment with at least one conventional systemic agent (regular administration at standard dosage for 12-24 weeks), or intolerant to adverse reactions.
- Considered suitable for treatment with picankibart as assessed by the clinician.
- Voluntarily participate in the study and provide written informed consent.
Key exclusion criteria (1 listed)
- Patients with active hepatitis B, hepatitis C, or tuberculosis. Pregnant patients or those planning pregnancy within 6 months. Subjects unable to comply with follow-up as required by the study protocol. Other conditions deemed unsuitable for this study.
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 |
|---|---|---|
| PicankibartInduction phase: Picankibart 200 mg administered subcutaneously at Weeks 0, 4, and 8. Maintenance phase: Picankibart 100 mg administered subcutaneously at Weeks 20, 32, and 44. | Drug | Picankibart in Palmoplantar Pustulosis |
Primary outcome
Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)
Time frame: 16 Week
Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)
Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)
Time frame: 16 Week
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 27 Apr 2026.
- Individual participant dataSharing planned: Yes
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
RecruitingPhase 2
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
Palmoplantar Pustulosis
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
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 Picankibart in people with Palmoplantar Pustulosis, 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 4 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 27 Apr 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?
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 Shuai Shao (8619249282690, 2269744794@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) (time frame: 16 Week). The study lists 2 primary outcomes in all. 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 27 Apr 2026.