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
πΊπΈLargo, Florida, United States
Site 102
πΊπΈSpringville, Utah, United States
Site 16-101
π«π·Paris, France
Site 59-101
π¬πͺTbilisi, Georgia
Site 30103
π΅π±Ossy, Poland
Site 59-105
π¬πͺTbilisi, Georgia
Site 17104
π©πͺBonn, Germany
Site 17105
π©πͺWΓΌrzburg, Germany
Site 17103
π©πͺHanau, Germany
Site 42104
π²πΎCheras, Malaysia
Site 42101
π²πΎKuala Lumpur, Malaysia
Site 45102
π°π·Seoul, Korea, Republic of
Site 45103
π°π·Seoul, Korea, Republic of
Site 45101
π°π·Pusan, Korea, Republic of
Site 42106
π²πΎJohor Bahru, Malaysia
Site 42-108
π²πΎPulau Pinang, Malaysia
Site 42-109
π²πΎSelayang Baru Utara, Malaysia
Site 64-103
π²π¦Casablanca, Morocco
Site 31-103
π·π΄IaΕi, Romania
Site 64-101
π²π¦Oujda, Morocco
Site 30104
π΅π±KrakΓ³w, Poland
Site 30101
π΅π±RzeszΓ³w, Poland
Site 30102
π΅π±WrocΕaw, Poland
Site 31-102
π·π΄Bucuresti, Romania
Site 63101
π¨π³Kaohsiung, Taiwan
Site 63102
π¨π³Taipei, Taiwan
Site 63103
π¨π³Taipei, Taiwan
Site 31-101
π·π΄Cluj-Napoca, Romania
Site 46101
πΉπBangkok, Thailand
Site 46102
πΉπChiang Mai, Thailand
Site 46104
πΉπKhon Kaen, Thailand
Site 64104
π¨π³Taipei, Taiwan
Site 46103
πΉπPathum Thani, Thailand
Site 62-101
πΉπ³Sfax, Tunisia
Site 62-102
πΉπ³Sousse, Tunisia
Site 33-107
πΉπ·Istanbul, Turkey
Site 62-103
πΉπ³Tunis, Tunisia
Site 33-101
πΉπ·Ankara, Turkey
Site 33-105
πΉπ·Istanbul, Turkey
Site 33-106
πΉπ·Istanbul, Turkey
Site 33-103
πΉπ·Antalya, Turkey
Site 33-102
πΉπ·Kayseri, Turkey
Site 33-104
πΉπ·NilΓΌfer, Turkey
Site 35102
π¦πΊSydney, Australia
Site 59102
π¬πͺTbilisi, Georgia
Site 35-101
π¦πΊMelbourne, Australia
Site 16-102
π«π·Nantes, France
Site 59104
π¬πͺBatumi, Georgia
Site 59103
π¬πͺTbilisi, Georgia
Site 42-107
π²πΎJohor Bahru, Malaysia
Site 24-101
πͺπΈBarcelona, Spain
Site 24-104
πͺπΈLas Palmas De Gran Canaria, Spain
Site 45104
π°π·Seoul, Korea, Republic of
Site 24-103
πͺπΈMadrid, Spain
Site 42105
π²πΎKota Bharu, Malaysia
Site 42-110
π²πΎKuala Lumpur, Malaysia
Site 42102
π²πΎMuar, Malaysia
Site 24-102
πͺπΈMadrid, Spain
Site 24-105
πͺπΈValencia, Spain
Site 30105
π΅π±ΕΓ³dΕΊ, Poland
Site 17102
π©πͺBensheim, Germany
Site 64-102
π²π¦Casablanca, Morocco
Site 42103
π²πΎPutrajaya, Malaysia
Site 105
πΊπΈLouisville, Kentucky, United States
Site 10-101
πΊπΈAnn Arbor, Michigan, United States
Site 101
πΊπΈAnn Arbor, Michigan, United States
Site 108
πΊπΈDallas, Texas, United States