NCT06274554RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 15 Feb 2024
- Start date
- 4 Oct 2024
- Primary completion date
- Dec 2028
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Crohn's disease
- NCT number
- NCT06274554
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 120
- From 4 Oct 2024 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Antifungal usage within one month prior to initiation of blinded fluconazole usage
Other illness
- Known allergy to fluconazole
- Severe Crohn's disease defined by a PRO-2 score ≥ 34 or imminent need for surgery, or deemed not medically fit by physician
- 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
Lab values
- 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
Other
- Pregnant or lactating women
- Patient with symptomatic stricturing
- Patient with pouchitis or an ostomy
Who the study is looking for
- Patients at least 18 years old
- Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.