Weill Medical College of Cornell University
The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to start or are currently undergoing standard of care treatment and plan to dose-escalate an IL-23 therapy for their Crohn's disease. The main question it aims to assess is whether or not patient response to IL-23 therapies improve when simultaneously treated with fluconazole.
The purpose of this study is to examine the efficacy and safety of fluconazole in combination with IL-23 therapy versus IL-23 therapy alone for the treatment of Crohn's disease (CD). IL-23 therapy may include ustekinumab (anti-interleukin-12/23), risankizumab (anti-interleukin-23), or guselkumab (anti-interleukin-23). Subjects will be stratified into two groups based on standard of care treatment: IL-23 therapy initiation or IL-23 therapy dose escalation. Subjects in each group will then be randomized to one of two treatment arms: 1. IL-23 Therapy with Fluconazole (200 mg on Day 0 and 100 mg…
Inclusion Criteria: 1. Patients at least 18 years old 2. Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450 Exclusion Criteria: 1. Antifungal usage within one month prior to initiation of blinded fluconazole usage 2. Known allergy to fluconazole 3. Patients with known hepatic disease, cirrhosis, or with elevated liver biochemistries (e.g., transaminase(s) \>3X upper limit of normal (ULN), and/or bilirubin levels \>1.5X ULN (with exception of confirmed Gilbert's disease) at baseline 4. Patients taking any medications judged by clinical provider to interact wit…
Oral fluconazole capsules.
Oral placebo capsules will be used as a comparator.
Risankizumab (IL-23), Guselkumab (IL-23), or Ustekinumab (IL-12/23) as standard of care treatment.
Arctuva estimate
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