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

NCT05366855 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-03-27

Study results available
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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).

Conditions

  • Generalized Pustular Psoriasis

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2024-07-12
Completion
2024-07-12
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Georgia
  • Germany
  • Malaysia
  • Morocco
  • Poland
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Tunisia
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05366855 on ClinicalTrials.gov