Testing Fluconazole with IL-23 Therapy for Crohn's Disease

This study is looking at whether adding fluconazole (an antifungal medicine) to standard IL-23 therapies (like risankizumab, guselkumab, or ustekinumab) can improve treatment for Crohn's disease. You might be able to join if you are at least 18 years old and have mild to moderate Crohn's disease, and are starting or increasing your dose of an IL-23 therapy. The main goal is to see if more people achieve a clinical response (meaning their symptoms improve) after 12 weeks when taking fluconazole with their IL-23 therapy compared to IL-23 therapy alone. The current status of this study is unclear, and it plans to enroll 120 participants.

Study design
This is an interventional study where participants will be randomly assigned to receive either fluconazole or a placebo (an inactive pill) along with their IL-23 therapy. It aims to enroll 120 participants.
What's involved
You would take oral fluconazole or placebo capsules for 14 days. You would also have standard clinic visits at 2 weeks and 12 weeks after starting treatment, with blood, stool, and oral swab samples collected at several time points. Biopsies may also be collected if you have an endoscopy.
Compensation
Not stated in the trial record.
Follow-up
Your clinical response will be measured at Week 12 after starting fluconazole or placebo.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06274554

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Weill Medical College of Cornell University
~120 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:FluconazolePlaceboIL-23 Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of subjects achieving clinical response
Measured over Week 12 post-Fluconazole Initiation
Crohn's Disease
Inflammatory Bowel Diseases
1 sites across 1 states
New York1
  • Randy Longman, MD, PhD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

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  • Proportion of subjects achieving clinical responseWeek 12 post-Fluconazole Initiation

    Participants with clinical response are those participants with a reduction of the Crohn's Disease Activity Index (CDAI) by 100 or more points from baseline at week 12 post-Fluconazole initiation.