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) ≥ 5%, a GPPPGA score ≥ 3 (moderate severity), and a PRS score ≥ 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
🇺🇸Springville, Utah, United States
Site 42101
🇲🇾Kuala Lumpur, Malaysia
Site 42102
🇲🇾Muar, Malaysia
Site 105
🇺🇸Louisville, Kentucky, United States
Site 108
🇺🇸Dallas, Texas, United States
Site 109
🇺🇸Largo, Florida, United States
Site 101
🇺🇸Ann Arbor, Michigan, United States
Site 59104
🇬🇪Batumi, Georgia
Site 35-101
🇦🇺Melbourne, Australia
Site 35102
🇦🇺Sydney, Australia
Site 50103
🇬🇪Tbilisi, Georgia
Site 59-105
🇬🇪Tbilisi, Georgia
Site 59-101
🇬🇪Tbilisi, Georgia
Site 59102
🇬🇪Tbilisi, Georgia
Site 17102
🇩🇪Bensheim, Germany
Site 17104
🇩🇪Bonn, Germany
Site 17105
🇩🇪Würzburg, Germany
Site 45101
🇰🇷Pusan, Korea, Republic of
Site 17103
🇩🇪Hanau, Germany
Site 62-103
🇹🇳Tunis, Tunisia
Site 33-102
🇹🇷Ankara, Turkey
Site 45103
🇰🇷Seoul, Korea, Republic of
Site 42105
🇲🇾Kota Bharu, Malaysia
Site 42104
🇲🇾Cheras, Malaysia
Site 42106
🇲🇾Johor Bahru, Malaysia
Site 42103
🇲🇾Putrajaya, Malaysia
Site 31-102
🇷🇴Bucuresti, Romania
Site 64-102
🇲🇦Casablanca, Morocco
Site 64-101
🇲🇦Oujda, Morocco
Site 30104
🇵🇱Kraków, Poland
Site 30101
🇵🇱Rzeszów, Poland
Site 64-103
🇲🇦Casablanca, Morocco
Site 30102
🇵🇱Wrocław, Poland
Site 30103
🇵🇱Ossy, Poland
Site 30105
🇵🇱Łódź, Poland
31-101
🇷🇴Cluj-Napoca, Romania
Site 31-103
🇷🇴Iaşi, Romania
Site 24-101
🇪🇸Barcelona, Spain
Site 38-101
🇸🇰Svidník, Slovakia
Site 24-104
🇪🇸Las Palmas De Gran Canaria, Spain
Site 63101
🇨🇳Kaohsiung, Taiwan
Site 24-103
🇪🇸Madrid, Spain
Sie 24-105
🇪🇸Valencia, Spain
Site 63102
🇨🇳Taipei, Taiwan
Site 63103
🇨🇳Taipei, Taiwan
Site 64104
🇨🇳Taipei, Taiwan
Site 46102
🇹🇭Chiang Mai, Thailand
Site 46101
🇹🇭Bangkok, Thailand
Site 46104
🇹🇭Khon Kaen, Thailand
Site 46103
🇹🇭Pathum Thani, Thailand
Site 62-101
🇹🇳Sfax, Tunisia
Site 62-102
🇹🇳Sousse, Tunisia
Site 33-103
🇹🇷Antalya, Turkey
Site 33-106
🇹🇷Istanbul, Turkey
Site 33-105
🇹🇷Istanbul, Turkey
Site 33-104
🇹🇷Nilufer, Turkey
Site 33-107
🇹🇷Istanbul, Turkey
Site 45102
🇰🇷Seoul, Korea, Republic of
Site 45104
🇰🇷Seoul, Korea, Republic of
Site 24-102
🇪🇸Madrid, Spain