Status:
TERMINATED
Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Generalized Pustular Psoriasis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- Use of prohibited medications between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 study.
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05366855
Start Date
April 21 2022
End Date
July 17 2024
Last Update
September 9 2025
Active Locations (67)
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1
Site 109
Largo, Florida, United States, 33771
2
Site 105
Louisville, Kentucky, United States, 40056
3
Site 10-101
Ann Arbor, Michigan, United States, 48108
4
Site 101
Ann Arbor, Michigan, United States, 48108