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

ConditionsCrohn's DiseaseInflammatory Bowel Diseases
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Fluconazole

    Drug

    Oral fluconazole capsules.

  • Placebo

    Drug

    Oral placebo capsules will be used as a comparator.

  • IL-23 Therapy

    Biological/Vaccine

    Risankizumab (IL-23), Guselkumab (IL-23), or Ustekinumab (IL-12/23) as standard of care treatment.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: IL-23 Therapy with FluconazoleExperimental treatment 2 interventions
Group B: IL-23 Therapy with PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of subjects achieving clinical response

Participants with clinical response are those participants with a reduction of the Crohn's Disease Activity Index (CDAI) by 100 or more points from baseline at week 12 post-Fluconazole initiation.

Time frame
Week 12 post-Fluconazole Initiation

Secondary outcomes

1

Proportion of subjects achieving clinical remission

Participants achieving clinical remission are those participants with a Crohn's Disease Activity Index (CDAI) score of no greater than 150 points at week 12 post-Fluconazole initiation.

Time frame
Week 12 post-Fluconazole Initiation
2

Proportion of patients achieving endoscopic response or remission

Participants achieving endoscopic response are those participants with a reduction in the Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from baseline. Participants achieving endoscopic remission are those participants with an SES-CD score less than or equal to 2

Time frame
Up to 1 Year post-Fluconazole Initiation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Source ClinicalTrials.gov
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