Picankibart in Palmoplantar Pustulosis

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) — 16 Week
  Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)
• Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) — 16 Week

Trial sites (1)

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