A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis

NCT ID: NCT03619902

Last Updated: 2025-09-16

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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-30

Study Completion Date

2021-01-20

Brief Summary

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The main objectives of this study are to evaluate the efficacy, safety and tolerability of imsidolimab in adults with active GPP.

Detailed Description

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Single arm, multiple-dose study evaluating the use of imsidolimab for the treatment of GPP.

Conditions

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Generalized Pustular Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imsidolimab

Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85.

Group Type EXPERIMENTAL

Imsidolimab

Intervention Type BIOLOGICAL

Humanized monoclonal antibody

Interventions

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Imsidolimab

Humanized monoclonal antibody

Intervention Type BIOLOGICAL

Other Intervention Names

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ANB019

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of active GPP
* Japanese Dermatology Association (JDA) severity index total score of at least 6 and erythema with pustules accounting for at least 10% of body surface area or a moderate severity score on Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA)
* Must be candidates for systemic therapy or phototherapy

Exclusion Criteria

* Erythrodermic, guttate psoriasis, drug induced GPP
* Any other ongoing inflammatory disease that interfere with the Investigator's ability to evaluate the subject's response to therapy
* History of recurrent or chronic 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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Site 102

Encino, California, United States

Site Status

Site 105

Largo, Florida, United States

Site Status

Site 104

Miami, Florida, United States

Site Status

Site 101

Indianapolis, Indiana, United States

Site Status

Site 100

Ann Arbor, Michigan, United States

Site Status

Site 303

Lodz, , Poland

Site Status

Site 302

Lodz, , Poland

Site Status

Site 304

Olsztyn, , Poland

Site Status

Site 301

Rzeszów, , Poland

Site Status

Site 501

Seoul, , South Korea

Site Status

Site 201

London, , United Kingdom

Site Status

Site 203

Newcastle upon Tyne, , United Kingdom

Site Status

Site 202

Salford, , United Kingdom

Site Status

Countries

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United States Poland South Korea United Kingdom

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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2017-004021-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ANB019-002

Identifier Type: -

Identifier Source: org_study_id

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