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

Vanda Pharmaceuticals45 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Generalized Pustular Psoriasis

Interventions

Imsidolimab high doseDRUG

intravenous

Imsidolimab low doseDRUG

intravenous

PlaceboOTHER

intravenous

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (60)

Outcomes

Primary Outcomes

Proportion of subjects achieving Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) score of 0 (clear) or 1 (almost clear)

Baseline to 0 (clear) or 1 (almost clear)

Time frame: week 4

Data from ClinicalTrials.gov

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Site 109

Largo, Florida, United States

Site 105

Louisville, Kentucky, United States

Site 101

Ann Arbor, Michigan, United States

Site 108

Dallas, Texas, United States

Site 102

Springville, Utah, United States

Site 35-101

Melbourne, Australia

Site 35102

Sydney, Australia

Site 59104

Batumi, Georgia

Site 50103

Tbilisi, Georgia

Site 59-101

Tbilisi, Georgia

...and 50 more locations