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

Phase 3 Completed 45 enrolled Vanda Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2022-04-14
Primary completion: 2023-08-17
Completion: 2023-08-17

Outcome

Met primary endpoint

paper P=0.023 for both the 300 mg vs. placebo comparison and 750 mg vs. placebo comparison PMID 42047557 ↗

Publications

Smieszek S, Przychodzen B, Tyner C, Johnson C, Bushman M, Brzezynski J, Reich A, Bachelez H, Yap EWY, Borlu M, Chaowattanapanit S, Denguezli M, Gudjonsson JE, Lizzul P, Dahl M, Parmley S, Randazzo B, Severtson A, Raina P, Saikali K, Xiao C, Polymeropoulos C, Birznieks G, Polymeropoulos M. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evid. 2026 May;5(5):EVIDoa2500272. doi: 10.1056/EVIDoa2500272. Epub 2026 Apr 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Imsidolimab	Monoclonal antibody	300 mg	Intravenous
Subject	Imsidolimab	Monoclonal antibody	750 mg	Intravenous