RightFit
RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "If subjects consent to biopsies, biopsies will also be collected for research at endoscopic procedures (colonoscopies and/or flexible sigmoidoscopies)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether fluconazole, a drug that treats fungal infections, helps IL-23 medicines work better for Crohn’s disease. It is for adults with mild to moderate Crohn’s disease who plan to start treatment or increase the dose of their IL-23 medicine.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Mild to moderate Crohn’s disease, with a CDAI disease activity score of 150–450.

Who can't join

  • Used an antifungal drug in the month before starting the study drug, or have a known allergy to fluconazole.
  • Known liver disease, liver scarring, or high liver blood test results: liver enzymes above 3 times normal or bilirubin above 1.5 times normal. The bilirubin rule has an exception for confirmed Gilbert’s disease.
  • Take medicines that your care provider says could cause serious harm when combined with fluconazole.
  • Pregnant or breastfeeding.
  • Severe Crohn’s disease, with a PRO-2 symptom score of 34 or higher; likely to need surgery soon; judged medically unfit by a doctor; or bowel narrowing that causes symptoms.
  • Pouchitis (swelling in a surgically made bowel pouch) or an ostomy (a surgically made opening for waste to leave the body).
  • A known, active fungal infection.
  • Low blood potassium, advanced heart failure, or kidneys that do not work well.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

NY