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

NCT05352893 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ANB019-301
• Study Type: interventional
• Target: 45
• Locations: 14 countries
• Sites: 62

Brief Summary

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).

Conditions

Generalized Pustular Psoriasis

Keywords

IL-36 Receptor; Imsidolimab; Interleukin-36

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear)

  The Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) is a physician-based assessment of the overall disease severity of GPP at the time of evaluation (specifically pustules, erythema, and scaling/crusting of pustular psoriasis lesions). The GPPPGA is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe). GPPPGA Scale: 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe.

  Week 4

Secondary Outcomes (1)

• Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear)

  Week 1

Study Arms (3)

750 mg Imsidolimab

EXPERIMENTAL

Drug: 750 mg Imsidolimab

300 mg Imsidolimab

EXPERIMENTAL

Drug: 300 mg Imsidolimab

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

750 mg Imsidolimab DRUG

Intravenous

Also known as: ANB019

750 mg Imsidolimab

300 mg Imsidolimab DRUG

Intravenous

Also known as: ANB019

300 mg Imsidolimab

Placebo OTHER

Intravenous

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• Subject has other form of psoriasis excluding psoriasis vulgaris
• Subject flare is so severe that patient's life is at risk

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (65)

Site 10-109

Largo, Florida, 33770, United States

Location

Site 10-105

Louisville, Kentucky, 40217, United States

Location

Site 10-101

Ann Arbor, Michigan, 48109, United States

Location

Site 10-108

Dallas, Texas, 75231, United States

Location

Site 10-102

Springville, Utah, 84663, United States

Location

Site 35-102

Melbourne, Victoria, 3128, Australia

Location

Site 16-102

Nantes, 44093, France

Location

Site 16-101

Paris, 75010, France

Location

Site 59-104

Batumi, 6000, Georgia

Location

Site 59-102

Tbilisi, 0112, Georgia

Location

Site 59-101

Tbilisi, 0160, Georgia

Location

Site 59-105

Tbilisi, 0160, Georgia

Location

Site 59-103

Tbilisi, 0179, Georgia

Location

Site 17-102

Bensheim, 48455, Germany

Location

Site 17-104

Bonn, 53127, Germany

Location

Site 17-103

Hanau, 63450, Germany

Location

Site 17-105

Würzburg, 97080, Germany

Location

Site 42-106

Johor Bahru, Johor, 80100, Malaysia

Location

Site 42-107

Johor Bahru, Johor, 81100, Malaysia

Location

Site 42-102

Muar town, Johor, 84000, Malaysia

Location

Site 42-105

Kota Bharu, Kelantan, 15586, Malaysia

Location

Site 42-108

Kuching, Sarawak, 93586, Malaysia

Location

Site 42-109

Batu Caves, Selangor, 59100, Malaysia

Location

Site 42-101

Kuala Lumpur, 50586, Malaysia

Location

Site 42-104

Kuala Lumpur, 56000, Malaysia

Location

Site 42-110

Kuala Lumpur, 59100, Malaysia

Location

Site 42-103

Putrajaya, 62250, Malaysia

Location

Site 64-103

Casablanca, 20360, Morocco

Location

Site 64-101

Marrakesh, 40000, Morocco

Location

Site 64-102

Oujda, 60000, Morocco

Location

Site 30-104

Krakow, 30-074, Poland

Location

Site 30-105

Lodz, 90-265, Poland

Location

Site 30-103

Ossy, 42-624, Poland

Location

Site 30-101

Rzeszów, 35-055, Poland

Location

Site 30-102

Wroclaw, 50-566, Poland

Location

Site 31-102

Bucharest, 020125, Romania

Location

Site 31-101

Cluj-Napoca, 400006, Romania

Location

Site 31-103

Iași, 700111, Romania

Location

Site 45-102

Busan, 49241, South Korea

Location

Site 45-104

Seoul, 03722, South Korea

Location

Site 45-101

Seoul, 05505, South Korea

Location

Site 45-103

Seoul, 06591, South Korea

Location

Site 24-101

Barcelona, 08036, Spain

Location

Site 24-104

Las Palmas de Gran Canaria, 35010, Spain

Location

Site 24-102

Madrid, 28040, Spain

Location

Site 24-103

Madrid, 28041, Spain

Location

Sie 24-105

Valencia, 46026, Spain

Location

Site 63-101

Kaohsiung City, 83301, Taiwan

Location

Site 63-103

New Taipei City, 23561, Taiwan

Location

Site 63-105

Taipei, 100225, Taiwan

Location

Site 63-104

Taipei, 11217, Taiwan

Location

Site 63-102

Taipei, 11696, Taiwan

Location

Site 46-101

Bangkok, 10400, Thailand

Location

Site 46-102

Chiang Mai, 50200, Thailand

Location

Site 46-104

Khon Kaen, 40002, Thailand

Location

Site 46-103

Pathum Thani, 12120, Thailand

Location

Site 62-101

Sfax, 3000, Tunisia

Location

Site 62-102

Sousse, 4000, Tunisia

Location

Site 62-103

Tunis, 1007, Tunisia

Location

Site 33-102

Ankara, 06560, Turkey (Türkiye)

Location

Site 33-104

Antalya, 07070, Turkey (Türkiye)

Location

Site 33-103

Bursa, 16059, Turkey (Türkiye)

Location

Site 33-105

Istanbul, 24093, Turkey (Türkiye)

Location

Site 33-106

Istanbul, 34010, Turkey (Türkiye)

Location

Site 33-101

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Vanda Pharmaceuticals Inc.
• Organization: Vanda Pharmaceuticals Inc.

clinicaltrials@vandapharma.com

202-734-3400

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: April 14, 2022
• Primary Completion: August 17, 2023
• Study Completion: August 17, 2023
• Last Updated: March 17, 2026
• Results First Posted: March 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (6); US (5); ES (5); TW (5); AU (1); PL (5); RO (3); MO (3); GE (5); KR (4); FR (2); MY (10); TH (4); DE (4)