Testing the Role for Anti-fungal Therapy in Improving the Response to Medicine for Crohn's Disease

Crohn's Disease Clinical Trial

Official title: 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

Status Not yet recruiting

Clinical Trial Summary

The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to or are undergoing standard of care treatment with an IL-23 therapy for their Crohn's disease.

The main question it aims to assess is will patient response to IL-23 therapies improve when simultaneously treated with fluconazole.

Clinical Trial Description

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) or risankizumab (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 on Days 1-13)

2. IL-23 Therapy with Placebo (200 mg on Day 0 and 100 mg on Days 1-13)

Subjects will blindly receive the fluconazole treatment only if they meet all inclusion and exclusion criteria. Subjects will return for standard of care clinic visits 2 weeks post-treatment initiation and 12 weeks post-treatment initiation. Disease activity will be assessed at standard of care visits. Stool and blood samples will collected for research from subjects at Day 0 (pre-treatment initiation), Week 2 post-treatment initiation, Week 8 post-treatment initiation, and Week 12 post-treatment initiation. If subjects consent to biopsies, biopsies will also be collected for research at endoscopic procedures (colonoscopies and/or flexible sigmoidoscopies). After Week 12, subjects will have the option to pursue open-label fluconazole treatment. Subjects will return at Week 24 and 1 year post-treatment initiation for standard of care visits, where blood and stool will also be collected for research. ;

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases

• NCT number: NCT06274554
• Study type: Interventional
• Source: Weill Medical College of Cornell University
• Contact: Nancy Tran, BS
• Phone: 646-697-0985
• Email: nat4010@med.cornell.edu
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Completion date: December 2029