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).
This study will also evaluate 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
42
Double-blind subcutaneous dosing
Double-blind subcutaneous dosing
Open-label subcutaneous dosing
Incidence of Adverse Events
Time frame: All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
Percentage of Subjects Maintaining GPPPGA Score of 0 or 1
Percentages are calculated using FCS imputation. 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 24
Kaplan-Meier Estimate for Time to First GPP Flare Recurrence (Weeks)
GPP flare was defined by a GPPPGA ≥3 (moderate) in subjects who had previously achieved a GPPPGA score of 0 (clear) or 1 (almost clear).
Time frame: From Day 1 until termination of study
Percentage of Subjects With Zero Recurrence of GPP Flare
Percentages are calculated using FCS imputation. GPP flare was defined by a GPPPGA ≥3 (moderate) in subjects who had previously achieved a GPPPGA score of 0 (clear) or 1 (almost clear)
Time frame: Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Any available therapy
Intravenous loading dose followed by subcutaneous dosing
Site 10-109
Largo, Florida, United States
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Louisville, Kentucky, United States
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