NCT07552454

Brief Summary

  1. 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. 2.Study Subjects
  3. 3.Aged 18-65 years, regardless of gender.
  4. 4.Patients with a confirmed diagnosis of palmoplantar pustulosis based on clinical manifestations and/or skin histopathology.
  5. 5.Failed treatment with at least one conventional systemic agent (regular administration at standard dosage for 12-24 weeks), or intolerant to adverse reactions.
  6. 6.Considered suitable for treatment with Picankibart as assessed by the clinician.
  7. 7.Voluntarily participate in the study and provide written informed consent.
  8. 8.Patients with active hepatitis B, hepatitis C, or tuberculosis.
  9. 9.Pregnant patients or those planning pregnancy within 6 months.
  10. 10.Subjects unable to comply with follow-up as required by the study protocol.
  11. 11.Other conditions deemed unsuitable for this study.
  12. 12.Subjects may withdraw from the study at any time for any reason.
  13. 13.Occurrence of a serious adverse event or intolerable adverse event.
  14. 14.Development of any item listed in the exclusion criteria during the study.
  15. 15.The investigator may decide subject withdrawal for medical reasons.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

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

Study Progress4%
Apr 2026Dec 2027

Study Start

First participant enrolled

April 15, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

April 20, 2026

Last Update Submit

April 20, 2026

Conditions

Palmoplantar Pustulosis

Outcome Measures

Primary Outcomes (2)

  • Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)

    Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)

    16 Week

  • Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)

    16 Week

Study Arms (1)

Picankibart in Palmoplantar Pustulosis

EXPERIMENTAL
Drug: Picankibart

Interventions

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.

Picankibart in Palmoplantar Pustulosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Shuai Shao

CONTACT

86192492826902269744794@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 27, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Locations

CN(1)