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Fluconazole + IL-23 Therapy for Crohn's Disease (FUN-CD Trial)

Phase 3

Recruiting

Led By Randy Longman, MD, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450

Patients at least 18 years old

Must not have

Patient with symptomatic stricturing

Patients with known hepatic disease or cirrhosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post-fluconazole initiation

Awards & highlights

Pivotal Trial

Summary

This trial aims to see if giving fluconazole along with IL-23 therapy to patients with Crohn's disease will improve their response to treatment.

Who is the study for?

This trial is for individuals with Crohn's Disease who are currently receiving or planning to start IL-23 therapy. Specific eligibility criteria were not provided, so it's important to contact the study organizers for detailed requirements.

What is being tested?

The trial is testing whether taking an anti-fungal medication called fluconazole alongside standard IL-23 therapy improves outcomes in Crohn's disease compared to a placebo (a pill without active medicine).

What are the potential side effects?

Fluconazole can cause headaches, nausea, stomach pain, dizziness, and changes in taste. IL-23 therapies may lead to infections, injection site reactions, and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Crohn's disease is mild to moderate.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have symptoms caused by a narrowing in my body.

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I have liver disease or cirrhosis.

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I am not on medications that interact badly with fluconazole.

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I have pouchitis or an ostomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post-fluconazole initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year post-fluconazole initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post-fluconazole initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of subjects achieving clinical response

Secondary study objectives

Proportion of patients achieving endoscopic response or remission

Proportion of subjects achieving clinical remission

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IL-23 Therapy with FluconazoleExperimental Treatment2 Interventions

Fluconazole will be blindly administered as capsules for oral consumption. On the first day, 200 mg will be given. Subjects will then take 100 mg once daily for thirteen days.

Group II: IL-23 Therapy with PlaceboPlacebo Group2 Interventions

Placebo will be blindly administered as capsules for oral consumption. On the first day, 200 mg will be given. Subjects will then take 100 mg once daily for thirteen days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluconazole

2017

Completed Phase 4

~4820

0 / 6Eligibility criteria met