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
NCT Number: NCT07552454
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Xi'an, Shaanxi, 710032, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
Time frame: 16 Week
Change in Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)
Time frame: 16 Week
Contact information is provided by the study sponsor or research team.
Xijing Hospital
Other
Efficacy and Safety of Picankibart in the Treatment of Moderate-to-Severe Palmoplantar Pustulosis: A Prospective, Single-Arm, Open-Label Clinical Study
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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