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

Phase 3 Terminated 42 enrolled Vanda Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2022-04-21
Primary completion: 2024-07-12
Completion: 2024-07-12

Outcome

Outcome not reported

Stopped: “AnaptysBio has concluded the GEMINI-2 trial, with all trial participants having been treated with imsidolimab for approximately six months and the furthest subject having been treated through 104 weeks.”

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	200 mg	Subcutaneous