Could a common antifungal improve Crohn's therapy?

NCT ID NCT06274554

Disease control Sponsor: Weill Medical College of Cornell University Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study is testing whether adding the antifungal drug fluconazole to standard IL-23 therapy helps people with mild to moderate Crohn's disease. About 120 adults will be randomly assigned to receive either fluconazole or a placebo alongside their usual treatment. The main goal is to see if more people achieve a significant reduction in symptoms after 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: fluconazole (an antifungal drug) added to standard IL-23 therapy (risankizumab, guselkumab, or ustekinumab)
What this could lead to: If it works, this could point toward a way to make existing Crohn's treatments more effective by targeting gut fungi.
What could go wrong: This is a phase 3 trial, but it's still relatively small (120 people) and the benefit of adding an antifungal is unproven. Fluconazole can cause liver issues and drug interactions.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 of QTc 5. Pregnant or lactating women 6. Severe Crohn's disease defined by a PRO-2 score ≥ 34 or imminent need for surgery, or deemed not medically fit by physician 7. Patient with symptomatic stricturing 8. Patient with pouchitis or an ostomy 9. 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. 10. Patients with hypokalemia, or advanced cardiac failure 11. Patients with renal insufficiency

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease Inflammatory bowel diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a common antifungal improve Crohn's therapy?

What the study statuses mean