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IL-23 Therapy with Fluconazole for Inflammatory Bowel Disease

Phase 3

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post-fluconazole initiation

Awards & highlights

Study 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.Check my eligibility

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).See study design

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

Select...

My Crohn's disease is mild to moderate.

Select...

I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of subjects achieving clinical response

Secondary outcome measures

Proportion of patients achieving endoscopic response or remission

Proportion of subjects achieving clinical remission

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. Subjects will have the option to take open-label fluconazole beginning at Week 12. (200 mg on the first day and 100 mg once daily for the next 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. Subjects will have the option to take open-label fluconazole beginning at Week 12. (200 mg on the first day and 100 mg once daily for the next thirteen days)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluconazole

2017

Completed Phase 4

~4820

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Leona M. and Harry B. Helmsley Charitable TrustOTHER

57 Previous Clinical Trials

93,773 Total Patients Enrolled

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,432 Total Patients Enrolled

Randy Longman, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University

1 Previous Clinical Trials

27 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new patients currently being accepted for enrollment in this medical study?

"Information available on clinicaltrials.gov shows that this particular trial is not presently seeking participants. Originally shared on June 1st, 2024, the last update was made on February 15th, 2024. While recruitment for this study has ceased, it's worth noting that there are currently 347 other trials actively enrolling patients."

Answered by AI

What are the safety considerations for individuals receiving IL-23 Therapy in combination with Fluconazole?

"Based on our evaluation at Power, IL-23 Therapy with Fluconazole is assigned a safety rating of 3. This reflects the advanced Phase 3 trial stage where effectiveness data is available alongside extensive safety records."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Testing the Role for Anti-fungal Therapy in Improving the Response to Medicine for Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06274554.

All > Inflammatory Bowel Disease