Picankibart in Palmoplantar Pustulosis

April 20, 2026 updated by: Xijing Hospital

Efficacy and Safety of Picankibart in the Treatment of Moderate-to-Severe Palmoplantar Pustulosis: A Prospective, Single-Arm, Open-Label Clinical Study

  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. Aged 18-65 years, regardless of gender.
  2. Patients with a confirmed diagnosis of palmoplantar pustulosis based on clinical manifestations and/or skin histopathology.
  3. Failed treatment with at least one conventional systemic agent (regular administration at standard dosage for 12-24 weeks), or intolerant to adverse reactions.
  4. Considered suitable for treatment with Picankibart as assessed by the clinician.
  5. Voluntarily participate in the study and provide written informed consent.

Exclusion Criteria

  1. Patients with active hepatitis B, hepatitis C, or tuberculosis.
  2. Pregnant patients or those planning pregnancy within 6 months.
  3. Subjects unable to comply with follow-up as required by the study protocol.
  4. Other conditions deemed unsuitable for this study.

Withdrawal Criteria

  1. Subjects may withdraw from the study at any time for any reason.
  2. Occurrence of a serious adverse event or intolerable adverse event.
  3. Development of any item listed in the exclusion criteria during the study.
  4. The investigator may decide subject withdrawal for medical reasons.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Department of Dermatology, Xijing Hospital, Fourth Military Medical University, No. 127 of West Changle Road, 710032, Xi'an, Shaanxi, China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Picankibart in Palmoplantar Pustulosis
Drug: Picankibart

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)
Time Frame: 16 Week
Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)
16 Week
Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)
Time Frame: 16 Week
16 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20262056-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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