Status:

COMPLETED

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

Lead Sponsor:

Vanda Pharmaceuticals

Conditions:

Generalized Pustular Psoriasis

Eligibility:

All Genders

18-80 years

Phase:

PHASE3

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 ...

Detailed Description

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

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

April 14 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 17 2023

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT05352893

Start Date

April 14 2022

End Date

August 17 2023

Last Update

September 9 2025

Active Locations (60)

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Page 1 of 15 (60 locations)

1

Site 109

Largo, Florida, United States, 33771

2

Site 105

Louisville, Kentucky, United States, 40056

3

Site 101

Ann Arbor, Michigan, United States, 48108

4

Site 108

Dallas, Texas, United States, 75061