Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease

Description

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.

Conditions

Crohn's Disease, Inflammatory Bowel Diseases

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Study Overview

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Study Details

Study overview

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.

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

Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease

Condition
Crohn's Disease
Intervention / Treatment

-

Contacts and Locations

New York

Weill Cornell Medicine, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 3. Besides the biologics of interest in this study, subjects must be on stable dosing of any therapy for at least 4 weeks prior to treatment initiation. Including:
  • 1. Steroids (9 mg or less of budesonide, 20 mg or less of prednisone)
  • 2. Mesalamines
  • 3. Immunomodulators
  • 4. Biologics
  • 5. Other medications for IBD (inflammatory bowel disease)
  • 1. Antibiotic usage within one month prior to initiation of blinded fluconazole usage
  • 2. Antifungal usage within one month prior to initiation of blinded fluconazole usage
  • 3. Known allergy to fluconazole
  • 4. 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
  • 5. Patients taking medications known to interact with fluconazole and cause serious adverse events, including but not limited to death, cardiac events, serious cardiac dysrhythmias, and prolongation of QTc (corrected QT interval)
  • 6. Pregnant or lactating women
  • 7. Severe Crohn's disease defined by a PRO-2 score ≥ 34 (patient reported outcomes) or imminent need for surgery, or deemed not medically fit by physician
  • 8. Patient with symptomatic stricturing
  • 9. Patient with pouchitis or an ostomy
  • 10. Patients with known, active fungal, or other, 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.
  • 11. Patients with hypokalemia, or advanced cardiac failure
  • 12. Patients with renal insufficiency

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

Randy Longman, MD, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2029-12