Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University
About this trial
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.
Eligibility criteria
Qualifiers
Patients at least 18 years old
Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450
Disqualifiers
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 disease) at baseline
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
Trial design
Treatments tested in this trial
- Fluconazole
- Placebo
- IL-23 Therapy
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Weill Medical College of Cornell University
Lead sponsor
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator
Source ClinicalTrials.gov