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Picankibart in Palmoplantar Pustulosis

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07552454
Enrollment
60
Registered
2026-04-27
Start date
2026-04-15
Completion date
2027-12-31
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palmoplantar Pustulosis

Brief 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. 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.

Interventions

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.

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)16 WeekChange in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)

Countries

China

Contacts

CONTACTShuai Shao
2269744794@qq.com8619249282690

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026