Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis
- Conditions
- Generalized Pustular Psoriasis
- Interventions
- Biological: ImsidolimabOther: Placebo
- Registration Number
- NCT05366855
- Lead Sponsor
- AnaptysBio, Inc.
- Brief 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).
- Detailed Description
This study will also evaluate the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 42
- Subject participated in the preceding placebo-controlled Phase 3 study ANB019-301 and completed at least the Week 1 visit of the ANB019-301 study without the use of rescue/prohibited medication for GPP
- Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment
- Use of prohibited medications between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IV +SC Imsidolimab Imsidolimab IV loading dose followed by subcutaneous Imsidolimab SC Imsidolimab Imsidolimab Subcutaneous Imsidolimab SC Placebo Placebo Subcutaneous Placebo
- Primary Outcome Measures
Name Time Method Incidence of adverse events Week 24 Incidence of adverse events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (67)
Site 109
🇺🇸Largo, Florida, United States
Site 102
🇺🇸Springville, Utah, United States
Site 16-101
🇫🇷Paris, France
Site 59-101
🇬🇪Tbilisi, Georgia
Site 30103
🇵🇱Ossy, Poland
Site 59-105
🇬🇪Tbilisi, Georgia
Site 17104
🇩🇪Bonn, Germany
Site 17105
🇩🇪Würzburg, Germany
Site 17103
🇩🇪Hanau, Germany
Site 42104
🇲🇾Cheras, Malaysia
Site 42101
🇲🇾Kuala Lumpur, Malaysia
Site 45102
🇰🇷Seoul, Korea, Republic of
Site 45103
🇰🇷Seoul, Korea, Republic of
Site 45101
🇰🇷Pusan, Korea, Republic of
Site 42106
🇲🇾Johor Bahru, Malaysia
Site 42-108
🇲🇾Pulau Pinang, Malaysia
Site 42-109
🇲🇾Selayang Baru Utara, Malaysia
Site 64-103
🇲🇦Casablanca, Morocco
Site 31-103
🇷🇴Iaşi, Romania
Site 64-101
🇲🇦Oujda, Morocco
Site 30104
🇵🇱Kraków, Poland
Site 30101
🇵🇱Rzeszów, Poland
Site 30102
🇵🇱Wrocław, Poland
Site 31-102
🇷🇴Bucuresti, Romania
Site 63101
🇨🇳Kaohsiung, Taiwan
Site 63102
🇨🇳Taipei, Taiwan
Site 63103
🇨🇳Taipei, Taiwan
Site 31-101
🇷🇴Cluj-Napoca, Romania
Site 46101
🇹🇭Bangkok, Thailand
Site 46102
🇹🇭Chiang Mai, Thailand
Site 46104
🇹🇭Khon Kaen, Thailand
Site 64104
🇨🇳Taipei, Taiwan
Site 46103
🇹🇭Pathum Thani, Thailand
Site 62-101
🇹🇳Sfax, Tunisia
Site 62-102
🇹🇳Sousse, Tunisia
Site 33-107
🇹🇷Istanbul, Turkey
Site 62-103
🇹🇳Tunis, Tunisia
Site 33-101
🇹🇷Ankara, Turkey
Site 33-105
🇹🇷Istanbul, Turkey
Site 33-106
🇹🇷Istanbul, Turkey
Site 33-103
🇹🇷Antalya, Turkey
Site 33-102
🇹🇷Kayseri, Turkey
Site 33-104
🇹🇷Nilüfer, Turkey
Site 35102
🇦🇺Sydney, Australia
Site 59102
🇬🇪Tbilisi, Georgia
Site 35-101
🇦🇺Melbourne, Australia
Site 16-102
🇫🇷Nantes, France
Site 59104
🇬🇪Batumi, Georgia
Site 59103
🇬🇪Tbilisi, Georgia
Site 42-107
🇲🇾Johor Bahru, Malaysia
Site 24-101
🇪🇸Barcelona, Spain
Site 24-104
🇪🇸Las Palmas De Gran Canaria, Spain
Site 45104
🇰🇷Seoul, Korea, Republic of
Site 24-103
🇪🇸Madrid, Spain
Site 42105
🇲🇾Kota Bharu, Malaysia
Site 42-110
🇲🇾Kuala Lumpur, Malaysia
Site 42102
🇲🇾Muar, Malaysia
Site 24-102
🇪🇸Madrid, Spain
Site 24-105
🇪🇸Valencia, Spain
Site 30105
🇵🇱Łódź, Poland
Site 17102
🇩🇪Bensheim, Germany
Site 64-102
🇲🇦Casablanca, Morocco
Site 42103
🇲🇾Putrajaya, Malaysia
Site 105
🇺🇸Louisville, Kentucky, United States
Site 10-101
🇺🇸Ann Arbor, Michigan, United States
Site 101
🇺🇸Ann Arbor, Michigan, United States
Site 108
🇺🇸Dallas, Texas, United States