Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Generalized Pustular Psoriasis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 ...
Detailed Description
This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.
Eligibility Criteria
Inclusion
- 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
Exclusion
- Subject has other form of psoriasis excluding psoriasis vulgaris
- Subject flare is so severe that patient's life is at risk
Key Trial Info
Start Date :
April 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05352893
Start Date
April 14 2022
End Date
August 17 2023
Last Update
September 9 2025
Active Locations (60)
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1
Site 109
Largo, Florida, United States, 33771
2
Site 105
Louisville, Kentucky, United States, 40056
3
Site 101
Ann Arbor, Michigan, United States, 48108
4
Site 108
Dallas, Texas, United States, 75061