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New treatment option for Crohn's Disease
Official title Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease
ClinicalTrials.gov ID: NCT06274554
What this study is testing
What is Fluconazole?
Fluconazole is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for crohn's disease.
Also referred to as Diflucan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients at least 18 years old
- Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450
You likely can't join if
- Antifungal usage within one month prior to initiation of blinded fluconazole usage
- Known allergy to fluconazole
- Patients with known hepatic disease, cirrhosis, or with elevated liver biochemistries (e.g., transaminase(s) \>3X upper limit of normal (ULN), and/or...
- Patients taking any medications judged by clinical provider to interact with fluconazole and are known contraindications (refer to section 2.2) and...
- Pregnant or lactating women
- Severe Crohn's disease defined by a PRO-2 score ≥ 34 or imminent need for surgery, or deemed not medically fit by physician
See the full eligibility criteria
- Patients at least 18 years old
- Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450
- Antifungal usage within one month prior to initiation of blinded fluconazole usage
- Known allergy to fluconazole
- 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...
- 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...
- Pregnant or lactating women
- Severe Crohn's disease defined by a PRO-2 score ≥ 34 or imminent need for surgery, or deemed not medically fit by physician
- Patient with symptomatic stricturing
- Patient with pouchitis or an ostomy
- 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...
- Patients with hypokalemia, or advanced cardiac failure
- Patients with renal insufficiency
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.