Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease
A Prospective, Randomized, Placebo-controlled Trial of Fluconazole in Combination With IL-23 Therapy Versus IL-23 Therapy Alone for the Treatment of Crohn's Disease
Weill Medical College of Cornell University
120 participants
Oct 4, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- Patients at least 18 years old
- Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450
Exclusion Criteria11
- Antifungal usage within one month prior to initiation of blinded fluconazole usage
- Known allergy to fluconazole
- 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
- Patients taking any medications judged by clinical provider to interact with fluconazole and are known contraindications (refer to section 2.2) and cause serious adverse events, including but not limited to death, cardiac events, serious cardiac dysrhythmias, and prolongation of QTc
- Pregnant or lactating women
- Severe Crohn's disease defined by a PRO-2 score ≥ 34 or imminent need for surgery, or deemed not medically fit by physician
- Patient with symptomatic stricturing
- Patient with pouchitis or an ostomy
- Patients with known, active fungal infection(s) since these patients would require particular, standard-of-care monitoring and treatment, which may include intravenous and/or prolonged courses of fluconazole or other therapies.
- Patients with hypokalemia, or advanced cardiac failure
- Patients with renal insufficiency
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06274554