A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

Vanda Pharmaceuticals102 sites in 12 countries45 target enrollmentApril 14, 2022

ConditionsGeneralized Pustular Psoriasis

Interventions750 mg Imsidolimab 300 mg Imsidolimab Placebo

Overview

Phase: Phase 3
Intervention: 750 mg Imsidolimab
Conditions: Generalized Pustular Psoriasis
Sponsor: Vanda Pharmaceuticals
Enrollment: 45
Locations: 102
Primary Endpoint: Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear)
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

April 14, 2022

End Date

August 17, 2023

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vanda Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

750 mg Imsidolimab

Intervention: 750 mg Imsidolimab

300 mg Imsidolimab

Intervention: 300 mg Imsidolimab

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: Week 4

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.