Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease
Phase 3 · Testing Fluconazole and IL-23 Therapy · 1 site · Weill Medical College of Cornell University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fluconazole (a drug) and IL-23 Therapy (a biologic) as a possible treatment. Condition(s) listed: Crohn's Disease and Inflammatory Bowel Diseases.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Patients at least 18 years old
- Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450
There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 120 participants are expected to take part.
- Start date: 2024-10-04.
- Main results expected around 2028-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Proportion of subjects achieving clinical response (Week 12 post-Fluconazole Initiation)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Crohn's Disease; Inflammatory Bowel Diseases |
| Lead sponsor | Weill Medical College of Cornell University |
| Collaborators | The Leona M. and Harry B. Helmsley Charitable Trust |
| Enrollment | 120 (estimated) |
| Start date | 2024-10-04 |
| Primary completion (est.) | 2028-12 |
| First posted | 2024-02-23 |
| Last updated | 2026-08-20 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06274554 |
Interventions
- Fluconazole (Drug)
Oral fluconazole capsules. - Placebo (Drug)
Oral placebo capsules will be used as a comparator. - IL-23 Therapy (Biological)
Risankizumab (IL-23), Guselkumab (IL-23), or Ustekinumab (IL-12/23) as standard of care treatment.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medicine | New York, New York | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.