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

NCT03619902 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: ANB019-0022017-004021-33
• Study Type: interventional
• Target: 8
• Locations: 4 countries
• Sites: 13

Brief Summary

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

Conditions

Generalized Pustular Psoriasis

Keywords

GPP

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale

  Clinical response was defined as "Very much improved," "Much Improved," or "Minimally Improved" on the CGI scale according to the Modified Japanese Dermatological Association Severity Index (JDA-SI) total score. The JDA-SI includes assessment of skin lesions (area of erythema with pustules, area of erythema total, and area of edema) and fever, white blood cell count, C-reactive protein and serum albumin levels. The total score ranges from 0 to 17 (severe). CGI was assessed based on the JDA-SI according to the following: * Very Much Improved: Reduction in JDA-SI total score by 3 or \> points; * Much improved: Reduction in JDA-SI total score by 1 or 2 points; * Minimally improved: No change in JDA-SI total score and area of erythema with pustules reduced by \<20% or clinically meaningful improvement in at least 1 other component of the modified JDA-SI.

  Week 4 and Week 16

• Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16

  Excluding palms and soles from 0% to 100%. The palmar surface of one hand (using the subject's hand and including the fingers) represents 1% of his or her total BSA.

  Baseline, Week 1, Week 4, and Week 16

Secondary Outcomes (3)

• Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16

  Baseline, Week 1, Week 4, and Week 16

• Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16

  Week 1, Week 4, and Week 16

• Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16

  Baseline and Week 1, Week 4, and Week 16

Study Arms (1)

Imsidolimab

EXPERIMENTAL

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.

Biological: Imsidolimab

Interventions

Imsidolimab BIOLOGICAL

Humanized monoclonal antibody

Also known as: ANB019

Imsidolimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (13)

Site 102

Encino, California, 91436, United States

Location

Site 105

Largo, Florida, 33771, United States

Location

Site 104

Miami, Florida, 33316, United States

Location

Site 101

Indianapolis, Indiana, 46250, United States

Location

Site 100

Ann Arbor, Michigan, 48109, United States

Location

Site 303

Lodz, 90-436, Poland

Location

Site 302

Lodz, Poland

Location

Site 304

Olsztyn, 10-229, Poland

Location

Site 301

Rzeszów, 35-055, Poland

Location

Site 501

Seoul, 03722, South Korea

Location

Site 201

London, United Kingdom

Location

Site 203

Newcastle upon Tyne, United Kingdom

Location

Site 202

Salford, United Kingdom

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
• Organization: Vanda Pharmaceuticals

clinicaltrials@vandapharma.com

202-734-3400

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 8, 2018
• Study Start: January 30, 2019
• Primary Completion: January 20, 2021
• Study Completion: January 20, 2021
• Last Updated: September 16, 2025
• Results First Posted: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); PL (4); GB (3); KR (1)