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

Phase 3

Completed

• Conditions: Generalized Pustular Psoriasis
• Interventions: Drug: Imsidolimab high dose; Drug: Imsidolimab low dose; Other: Placebo

• Registration Number: NCT05352893
• Lead Sponsor: AnaptysBio, Inc.

Brief 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).

Detailed Description

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

Study Timeline

• Study Start: 2022-04-14
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-29
• Primary Completion: 2023-08-17
• Study Completion: 2023-08-17
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV high dose Imsidolimab, other name ANB019	Imsidolimab high dose	ANB019 Biological Humanized Monoclonal Antibody High Dose
IV low dose Imsidolimab, other name ANB019	Imsidolimab low dose	ANB019 Biological Humanized Monoclonal Antibody Low Dose
IV Placebo	Placebo	Placebo Solution

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) score of 0 (clear) or 1 (almost clear)	week 4	Baseline to 0 (clear) or 1 (almost clear)

Trial Locations

Locations (60)

Site 109; 🇺🇸 Largo, Florida, United States

Site 105; 🇺🇸 Louisville, Kentucky, United States

Site 101; 🇺🇸 Ann Arbor, Michigan, United States

Site 108; 🇺🇸 Dallas, Texas, United States

Site 102; 🇺🇸 Springville, Utah, United States

Site 35-101; 🇦🇺 Melbourne, Australia

Site 35102; 🇦🇺 Sydney, Australia

Site 59104; 🇬🇪 Batumi, Georgia

Site 50103; 🇬🇪 Tbilisi, Georgia

Site 59-101; 🇬🇪 Tbilisi, Georgia

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