NCT03633396Phase 2Completed

A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2021-04-23Actual

Enrollment · participants59Actual

Source updated2025-09-15Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Palmoplantar Pustulosis

Treatments or interventions studied

ImsidolimabBiologicalAlso known as ANB019
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI); description: The Palmoplantar Pustulosis Area and Severity Index (PPPASI) is used to assess the severity of palmoplantar pustulosis lesions and their response to therapy. The glabrous skin of both palms and both soles are assessed for erythema, pustules, and desquamation (scaling), each on a scale from 0 (none) to 4 (very severe). The area affected of each palm and sole is scored from 0 (0%) to 6 (90-100%). Scores for the 3 characteristics of PPP are summed and adjusted for the area affected, and the scores for each palm and sole are added to calculate the total score. The PPPASI total score ranges from 0 to 72. A higher score indicates more severe disease, and a negative change from Baseline indicates improvement.; timeFrame: Baseline to Week 16; measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs); description: Clinical safety was evaluated by reporting incidence of adverse events up to week 24. TEAEs are defined as new events that occured during or after first dose of study drug or any event that worsens after first dose of study drug. A serious AE (SAE) is defined as any untoward medical occurrence that resulted in death, was life-threatening, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or an important medical event that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above. Severity was assessed by the Investigator as mild (easily tolerated, causing minimal discomfort and not interfering with everyday activities), moderate (causes sufficient discomfort and interferes with normal everyday activities) or severe (prevents normal everyday activities). The Investigator assessed the relationship between study treatment and each AE based on clinical judgement.; timeFrame: From first dose of any study drug to Week 24

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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