Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's
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 therapie
| Condition(s) | Crohn's Disease, Inflammatory Bowel Diseases |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 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 o |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Weill Medical College of Cornell University |
| Locations | New York, New York, United States |
| Start date | 2024-10-04 |
| NCT ID | NCT06274554 |
| Official listing | https://clinicaltrials.gov/study/NCT06274554 |