The purpose of this study is to compare the good and bad effects of guselkumab to the good and bad effects of placebo.
This Phase 3 study aims to evaluate the efficacy and safety of guselkumab in the treatment of adult participants with active fistulizing, perianal Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or biologic therapy or have medical contraindications to such therapies.
Study is divided into screening, treatment period and follow up phase. There are 3 treatment groups in this study. Participants will have 80% chance of being put in a guselkumab group, with a 40% chance of being put in guselkumab group 1 and 40% chance of being put in guselkumab group 2 and 20% chance of being put into the placebo group (group 3). Participants will receive one IV infusion of either guselkumab (group 1 and 2) or placebo (group 3).
- Category
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Trial status
Recruiting
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Trial phase
Phase 3 Drug TrialLate stage studies conducted to confirm efficacy and safety of investigational therapies in large patient populations prior to introduction to clinical practice.
- Registry listing
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ERM Project ID
85799
Trial contact details
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Contact person
Sharyn Grossman
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Phone
07 3163 8195
What you need to know
You may participate if:
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You are over 18
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Have a history of CD
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Have at least on active, draining fistula as a CD complication
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Haven't responded to previous therapy
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Meet the detailed inclusion/exclusion criteria
You may not participate if:
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You have very severe disease
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Have current complications
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Test positive for number of conditions
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Have a history of serious infection just prior to screening
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Have a history of malignancy
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Meet the detailed inclusion/exclusion criteria
Trial Dates
December 2023 - April 2025