NCT05366855

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

A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

Detailed description

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

Conditions

• Generalized Pustular Psoriasis

Interventions

Type	Name	Description
DRUG	Double-blind 200 mg imsidolimab	Double-blind subcutaneous dosing
OTHER	Placebo	Double-blind subcutaneous dosing
DRUG	Open-label 200 mg imsidolimab	Open-label subcutaneous dosing
OTHER	Standard of Care (SOC)	Any available therapy
DRUG	Imsidolimab 750 mg IV/200 mg SC	Intravenous loading dose followed by subcutaneous dosing

Timeline

• Start date: 2022-04-21
• Primary completion: 2024-07-12
• Completion: 2024-07-12
• First posted: 2022-05-09
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

65 sites across 15 countries: United States, Australia, France, Georgia, Germany, Malaysia, Morocco, Poland, Romania, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study