Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
- Conditions
- Generalized Pustular Psoriasis
- Interventions
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
-Subject has a BSA affected with pustules (excluding palms and soles) β₯ 5%, a GPPPGA score β₯ 3 (moderate severity), and a PRS score β₯ 3 (moderate severity) at Day 1
- 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (60)
Site 102
πΊπΈSpringville, Utah, United States
Site 42101
π²πΎKuala Lumpur, Malaysia
Site 42102
π²πΎMuar, Malaysia
Site 105
πΊπΈLouisville, Kentucky, United States
Site 108
πΊπΈDallas, Texas, United States
Site 109
πΊπΈLargo, Florida, United States
Site 101
πΊπΈAnn Arbor, Michigan, United States
Site 59104
π¬πͺBatumi, Georgia
Site 35-101
π¦πΊMelbourne, Australia
Site 35102
π¦πΊSydney, Australia
Site 50103
π¬πͺTbilisi, Georgia
Site 59-105
π¬πͺTbilisi, Georgia
Site 59-101
π¬πͺTbilisi, Georgia
Site 59102
π¬πͺTbilisi, Georgia
Site 17102
π©πͺBensheim, Germany
Site 17104
π©πͺBonn, Germany
Site 17105
π©πͺWΓΌrzburg, Germany
Site 45101
π°π·Pusan, Korea, Republic of
Site 17103
π©πͺHanau, Germany
Site 62-103
πΉπ³Tunis, Tunisia
Site 33-102
πΉπ·Ankara, Turkey
Site 45103
π°π·Seoul, Korea, Republic of
Site 42105
π²πΎKota Bharu, Malaysia
Site 42104
π²πΎCheras, Malaysia
Site 42106
π²πΎJohor Bahru, Malaysia
Site 42103
π²πΎPutrajaya, Malaysia
Site 31-102
π·π΄Bucuresti, Romania
Site 64-102
π²π¦Casablanca, Morocco
Site 64-101
π²π¦Oujda, Morocco
Site 30104
π΅π±KrakΓ³w, Poland
Site 30101
π΅π±RzeszΓ³w, Poland
Site 64-103
π²π¦Casablanca, Morocco
Site 30102
π΅π±WrocΕaw, Poland
Site 30103
π΅π±Ossy, Poland
Site 30105
π΅π±ΕΓ³dΕΊ, Poland
31-101
π·π΄Cluj-Napoca, Romania
Site 31-103
π·π΄IaΕi, Romania
Site 24-101
πͺπΈBarcelona, Spain
Site 38-101
πΈπ°SvidnΓk, Slovakia
Site 24-104
πͺπΈLas Palmas De Gran Canaria, Spain
Site 63101
π¨π³Kaohsiung, Taiwan
Site 24-103
πͺπΈMadrid, Spain
Sie 24-105
πͺπΈValencia, Spain
Site 63102
π¨π³Taipei, Taiwan
Site 63103
π¨π³Taipei, Taiwan
Site 64104
π¨π³Taipei, Taiwan
Site 46102
πΉπChiang Mai, Thailand
Site 46101
πΉπBangkok, Thailand
Site 46104
πΉπKhon Kaen, Thailand
Site 46103
πΉπPathum Thani, Thailand
Site 62-101
πΉπ³Sfax, Tunisia
Site 62-102
πΉπ³Sousse, Tunisia
Site 33-103
πΉπ·Antalya, Turkey
Site 33-106
πΉπ·Istanbul, Turkey
Site 33-105
πΉπ·Istanbul, Turkey
Site 33-104
πΉπ·Nilufer, Turkey
Site 33-107
πΉπ·Istanbul, Turkey
Site 45102
π°π·Seoul, Korea, Republic of
Site 45104
π°π·Seoul, Korea, Republic of
Site 24-102
πͺπΈMadrid, Spain