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 psoriasis (GPP).
This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear)
The Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) is a physician-based assessment of the overall disease severity of GPP at the time of evaluation (specifically pustules, erythema, and scaling/crusting of pustular psoriasis lesions). The GPPPGA is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe). GPPPGA Scale: 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe.
Time frame: Week 4
Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear)
The Pustulation Rating Scale (PRS) is is a physician-based assessment of the severity of GPP pustulation. Pustulation is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe). PRS Scale: 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe.
Time frame: Week 1
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