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

NCT06274554 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Fluconazole

Oral fluconazole capsules.

DRUG

Placebo

Oral placebo capsules will be used as a comparator.

BIOLOGICAL

IL-23 Therapy

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

Sponsors & Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Randy Longman, MD, PhD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-04
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06274554 on ClinicalTrials.gov