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NCT Number: NCT07552454

Picankibart in Palmoplantar Pustulosis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Location status: Recruiting

Location contact

Shuai Shao, MD PhD

CONTACT

[email protected]

8619249282690

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Picankibart

Drug

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.

Primary outcomes

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

    Time frame: 16 Week

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

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

    Time frame: 16 Week

Study contacts

Contact information is provided by the study sponsor or research team.

Shuai Shao

CONTACT

[email protected]

8619249282690

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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