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

NCT ID: NCT03633396

Last Updated: 2025-09-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-20

Study Completion Date

2021-04-23

Brief Summary

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

Detailed Description

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Conditions

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Palmoplantar Pustulosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered by subcutaneous injection once a month

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.

Group Type EXPERIMENTAL

Imsidolimab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection once a month

Interventions

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Imsidolimab

Administered by subcutaneous injection once a month

Intervention Type BIOLOGICAL

Placebo

Administered by subcutaneous injection once a month

Intervention Type DRUG

Other Intervention Names

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ANB019

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigational Site

Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Encino, California, United States

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Santa Monica, California, United States

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Fort Lauderdale, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Indianapolis, Indiana, United States

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Plainfield, Indiana, United States

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Overland Park, Kansas, United States

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Ann Arbor, Michigan, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Wilmington, North Carolina, United States

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Columbus, Ohio, United States

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Norman, Oklahoma, United States

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Portland, Oregon, United States

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Dallas, Texas, United States

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Surrey, British Columbia, Canada

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Greater Sudbury, Ontario, Canada

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Markham, Ontario, Canada

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Drummondville, Quebec, Canada

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Montreal, Quebec, Canada

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Bad Bentheim, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bonn, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Schwerin, , Germany

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Gdansk, , Poland

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Katowice, , Poland

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Lodz, , Poland

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Olsztyn, , Poland

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Ostrowiec Świętokrzyski, , Poland

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Rzeszów, , Poland

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Szczecin, , Poland

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Wroclaw, , Poland

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Countries

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United States Canada Germany Poland

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017-004022-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ANB019-003

Identifier Type: -

Identifier Source: org_study_id

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