Immunogenetic Profiling of Guselkumab for the Treatment of Plaque and Guttate Psoriasis
This is a two-arm open-label study to evaluate the clinical and immunogenetic responses of patients with plaque or guttate psoriasis to treatment with guselkumab.
⁃ For subjects with guttate psoriasis:
• Ability to provide written informed consent and comply with the protocol.
• At least 18 years of age.
• Diagnosis of guttate psoriasis.
• Onset of guttate psoriasis within 12 months.
• Body surface area (BSA) involvement greater than or equal to 5%.
• PASI greater than or equal to 4.
• Subject is considered a candidate for phototherapy or systemic therapy.
• Subject is unlikely to conceive due to male, post-menopausal, or using adequate contraceptive (barrier, hormonal, implant, or permanent sterilization methods). Women of childbearing potential will be allowed to enroll provided they practice adequate forms of birth control.
• Physical exam with no evidence of active skin infection and/or other findings that indicate chronic disease or concomitant inflammatory/immune-mediated skin disease other than psoriasis.
⁃ For subjects with chronic plaque psoriasis (control):
• Ability to provide written informed consent and comply with the protocol.
• At least 18 years of age.
• Diagnosis of plaque psoriasis.
• Duration of plaque psoriasis \>5 years.
• Body surface area (BSA) involvement greater than or equal to 5%.
• Subject is considered a candidate for phototherapy or systemic therapy.
• Subject is unlikely to conceive due to male, post-menopausal, or using adequate contraceptive (barrier, hormonal, implant, or permanent sterilization methods). Women of childbearing potential will be allowed to enroll provided they practice adequate forms of birth control.
• Physical exam with no evidence of active skin infection and/or other findings that indicate chronic disease or concomitant inflammatory/immune-mediated skin disease other than psoriasis.