Phase 3 N=45 Randomized Quadruple-blind Treatment

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

Generalized Pustular Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT05352893 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Mar 2026

Primary outcome: Primary: Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear) — 8; 8; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 750 mg Imsidolimab (Drug); 300 mg Imsidolimab (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanda Pharmaceuticals
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear)	8; 8; 2	—
SECONDARY Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear)	6; 10; 2	—

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05352893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.