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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients at least 18 years old

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

• 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:

‣ Steroids (9 mg or less of budesonide, 20 mg or less of prednisone)

⁃ Mesalamines

⁃ Immunomodulators

⁃ Biologics

⁃ Other medications for IBD (inflammatory bowel disease)

Locations
United States
New York
Weill Cornell Medicine
RECRUITING
New York
Contact Information
Primary
Grace Xiang, BS
grx4001@med.cornell.edu
646-697-0985
Backup
Caroline Ericsson, BS
cae4007@med.cornell.edu
646-697-0985
Time Frame
Start Date: 2024-10-04
Estimated Completion Date: 2029-12
Participants
Target number of participants: 120
Treatments
Experimental: IL-23 Therapy with Fluconazole
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.
Placebo_comparator: IL-23 Therapy with Placebo
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.
Related Therapeutic Areas
Sponsors
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov