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

September 2, 2025 updated by: Vanda Pharmaceuticals

A Phase 2, Randomized, Placebo-controlled, Double-blind, Multiple Dose Study to Evaluate the Efficacy and Safety of ANB019 in Subjects With Palmoplantar Pustulosis

A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple doses of imsidolimab (ANB019) in adults with palmoplantar pustulosis (PPP)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada
        • Investigational Site
    • Ontario
      • Greater Sudbury, Ontario, Canada
        • Investigational Site
      • Markham, Ontario, Canada
        • Investigational Site
    • Quebec
      • Drummondville, Quebec, Canada
        • Investigational Site
      • Montreal, Quebec, Canada
        • Investigational Site
  • Germany
      • Bad Bentheim, Germany, 48455
        • Investigational Site
      • Berlin, Germany, 10117
        • Investigational Site
      • Berlin, Germany, 10789
        • Investigational Site
      • Bonn, Germany, 53127
        • Investigational Site
      • Hamburg, Germany, 22391
        • Investigational Site
      • Hamburg, Germany, 20253
        • Investigational Site
      • Schwerin, Germany, 19055
        • Investigational Site
  • Poland
      • Gdansk, Poland, 80-546
        • Investigational Site
      • Katowice, Poland, 40-611
        • Investigational Site
      • Lodz, Poland, 90-265
        • Investigational Site
      • Olsztyn, Poland, 10-229
        • Investigational Site
      • Ostrowiec Świętokrzyski, Poland, 27-400
        • Investigational Site
      • Rzeszów, Poland, 35-055
        • Investigational Site
      • Szczecin, Poland, 70-332
        • Investigational Site
      • Wroclaw, Poland, 50-566
        • Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Investigational Site
    • California
      • Encino, California, United States, 91436
        • Investigational Site
      • Santa Monica, California, United States, 90405
        • Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Investigational Site
      • Miami, Florida, United States, 33155
        • Investigational Site
      • Pembroke Pines, Florida, United States, 33028
        • Investigational Site
      • Tampa, Florida, United States, 33607
        • Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Investigational Site
      • Plainfield, Indiana, United States, 46168
        • Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Investigational Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Investigational Site
      • St Louis, Missouri, United States, 63117
        • Investigational Site
    • North Carolina
      • Wilmington, North Carolina, United States, 28405
        • Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43230
        • Investigational Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinically confirmed diagnosis of PPP
  • Disease duration of at least 6 months prior to screening
  • Present with active pustules on palms or/and soles at screening

Exclusion Criteria:

  • Any other ongoing inflammatory disease that interfere with the investigator's ability to evaluate the subject's response to therapy
  • History of recurrent or active/serious infection
  • Ongoing use of psoriasis prohibited medication

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo administered by subcutaneous injection on Day 1 followed by monthly doses of placebo by subcutaneous injection on Days 29, 57, and 85.
Drug: Placebo
Administered by subcutaneous injection once a month
Experimental: imsidolimab
Participants will receive 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
Biological: Imsidolimab
Administered by subcutaneous injection once a month
Other Names:
  • ANB019

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI)
Time Frame: Baseline to Week 16
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.
Baseline to Week 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: From first dose of any study drug to Week 24

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.
From first dose of any study drug to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50)
Time Frame: Baseline to Week 16
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.
Baseline to Week 16
Percentage of Participants Who Achieved a Clear or Almost Clear Palmoplantar Pustulosis Investigator's Global Assessment (PPPIGA) Score at Week 16
Time Frame: Week 16

The Investigator rated the severity of participants' disease on the following 5-point scale:

  • 0: Clear - No signs of palmoplantar pustulosis; no scaling or crusts or pustules remain;
  • 1: Almost clear - Slight scaling and/or erythema and/or slight crusts; very few (yellow) and/or old (brown) pustules;
  • 2: Mild - Scaling and/or erythema and/or crusts; visible new (yellow) and/or old (brown) pustules of limited number and extent;
  • 3: Moderate - Prominent scaling and/or erythema and/or crusting; prominent new (yellow) and/or old (brown) pustules covering most of the area involved;
  • 4: Severe - Severe scaling and/or erythema and/or crusting; numerous new (yellow) and/or old (brown) pustules with / without major confluence, covering the entire area of at least 2 palmoplantar sites.
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2019

Primary Completion (Actual)

April 23, 2021

Study Completion (Actual)

April 23, 2021

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 16, 2018

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANB019-003
  • 2017-004022-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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