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.
Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Randy Longman, MD, PhD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.