Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP

NCT ID: NCT05352893

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-14

Study Completion Date

2023-08-17

Brief Summary

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This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

Detailed Description

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This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.

Conditions

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Generalized Pustular Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
On Day 1, eligible subjects will be randomized in a 1:1:1 ratio to receive a single intravenous (IV) high dose imsidolimab, low dose imsidolimab, or placebo.

Study Groups

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IV high dose Imsidolimab, other name ANB019

ANB019 Biological Humanized Monoclonal Antibody High Dose

Group Type EXPERIMENTAL

Imsidolimab high dose

Intervention Type DRUG

intravenous

IV low dose Imsidolimab, other name ANB019

ANB019 Biological Humanized Monoclonal Antibody Low Dose

Group Type EXPERIMENTAL

Imsidolimab low dose

Intervention Type DRUG

intravenous

IV Placebo

Placebo Solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

intravenous

Interventions

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Imsidolimab high dose

intravenous

Intervention Type DRUG

Imsidolimab low dose

intravenous

Intervention Type DRUG

Placebo

intravenous

Intervention Type OTHER

Other Intervention Names

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ANB019 ANB019

Eligibility Criteria

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Inclusion Criteria

-Subject has a BSA affected with pustules (excluding palms and soles) ≥ 5%, a GPPPGA score ≥ 3 (moderate severity), and a PRS score ≥ 3 (moderate severity) at Day 1

Exclusion Criteria

* Subject has other form of psoriasis excluding psoriasis vulgaris
* Subject flare is so severe that patient's life is at risk
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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 109

Largo, Florida, United States

Site Status

Site 105

Louisville, Kentucky, United States

Site Status

Site 101

Ann Arbor, Michigan, United States

Site Status

Site 108

Dallas, Texas, United States

Site Status

Site 102

Springville, Utah, United States

Site Status

Site 35-101

Melbourne, , Australia

Site Status

Site 35102

Sydney, , Australia

Site Status

Site 59104

Batumi, , Georgia

Site Status

Site 50103

Tbilisi, , Georgia

Site Status

Site 59-101

Tbilisi, , Georgia

Site Status

Site 59-105

Tbilisi, , Georgia

Site Status

Site 59102

Tbilisi, , Georgia

Site Status

Site 17102

Bensheim, , Germany

Site Status

Site 17104

Bonn, , Germany

Site Status

Site 17103

Hanau, , Germany

Site Status

Site 17105

Würzburg, , Germany

Site Status

Site 42104

Cheras, , Malaysia

Site Status

Site 42106

Johor Bahru, , Malaysia

Site Status

Site 42105

Kota Bharu, , Malaysia

Site Status

Site 42101

Kuala Lumpur, , Malaysia

Site Status

Site 42102

Muar town, , Malaysia

Site Status

Site 42103

Putrajaya, , Malaysia

Site Status

Site 64-102

Casablanca, , Morocco

Site Status

Site 64-103

Casablanca, , Morocco

Site Status

Site 64-101

Oujda, , Morocco

Site Status

Site 30104

Krakow, , Poland

Site Status

Site 30105

Lodz, , Poland

Site Status

Site 30103

Ossy, , Poland

Site Status

Site 30101

Rzeszów, , Poland

Site Status

Site 30102

Wroclaw, , Poland

Site Status

Site 31-102

Bucharest, , Romania

Site Status

31-101

Cluj-Napoca, , Romania

Site Status

Site 31-103

Iași, , Romania

Site Status

Site 38-101

Svidník, , Slovakia

Site Status

Site 45101

Pusan, , South Korea

Site Status

Site 45102

Seoul, , South Korea

Site Status

Site 45103

Seoul, , South Korea

Site Status

Site 45104

Seoul, , South Korea

Site Status

Site 24-101

Barcelona, , Spain

Site Status

Site 24-104

Las Palmas de Gran Canaria, , Spain

Site Status

Site 24-102

Madrid, , Spain

Site Status

Site 24-103

Madrid, , Spain

Site Status

Sie 24-105

Valencia, , Spain

Site Status

Site 63101

Kaohsiung City, , Taiwan

Site Status

Site 63102

Taipei, , Taiwan

Site Status

Site 63103

Taipei, , Taiwan

Site Status

Site 64104

Taipei, , Taiwan

Site Status

Site 46101

Bangkok, , Thailand

Site Status

Site 46102

Chiang Mai, , Thailand

Site Status

Site 46104

Khon Kaen, , Thailand

Site Status

Site 46103

Pathum Thani, , Thailand

Site Status

Site 62-101

Sfax, , Tunisia

Site Status

Site 62-102

Sousse, , Tunisia

Site Status

Site 62-103

Tunis, , Tunisia

Site Status

Site 33-102

Ankara, , Turkey (Türkiye)

Site Status

Site 33-103

Antalya, , Turkey (Türkiye)

Site Status

Site 33-105

Istanbul, , Turkey (Türkiye)

Site Status

Site 33-106

Istanbul, , Turkey (Türkiye)

Site Status

Site 33-107

Istanbul, , Turkey (Türkiye)

Site Status

Site 33-104

Nilufer, , Turkey (Türkiye)

Site Status

Countries

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United States Australia Georgia Germany Malaysia Morocco Poland Romania Slovakia South Korea Spain Taiwan Thailand Tunisia Turkey (Türkiye)

Other Identifiers

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ANB019-301

Identifier Type: -

Identifier Source: org_study_id

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