Guselkumab Immunogenetics
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Plaque Psoriasis
- Psoriasis Guttate
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a single center, open-label study. Twenty-five subjects are planned (15 with new-onset guttate psoriasis and 10 with chronic plaque psoriasis). Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Guselkumab (Tremfya®), an IL-23 inhibitor approved for the treatment of moderate-to-severe plaque psoriasis. Given the potential role of IL-23 in the pathogenesis of guttate psoriasis, guselkumab may be an effective option to treat the initial manifestation of guttate psoriasis. This is a two-arm op...
Guselkumab (Tremfya®), an IL-23 inhibitor approved for the treatment of moderate-to-severe plaque psoriasis. Given the potential role of IL-23 in the pathogenesis of guttate psoriasis, guselkumab may be an effective option to treat the initial manifestation of 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. The primary objective of this study is to assess how treatment with guselkumab changes the immune milieu of the skin in patients with plaque or guttate psoriasis. The secondary objectives of this study are to assess how treatment with guselkumab affects the quality of life and extent of skin disease in patients with plaque or guttate psoriasis.
Tracking Information
- NCT #
- NCT04645355
- Collaborators
- Janssen Biotech, Inc.
- Investigators
- Principal Investigator: Wilson Liao, MD University of California, San Francisco
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