Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis
Phase 3
Terminated
- Conditions
- Generalized Pustular Psoriasis
- 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
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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 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
Site 102
🇺🇸Springville, Utah, United States
Site 35-101
🇦🇺Melbourne, Australia
Site 35102
🇦🇺Sydney, Australia
Site 16-102
🇫🇷Nantes, France
Site 16-101
🇫🇷Paris, France
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