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

NCT06274554 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 23-11026746
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Crohn's Disease; Inflammatory Bowel Diseases

Keywords

Fluconazole; IL-23

Outcome Measures

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.

  Week 12 post-Fluconazole Initiation

Secondary Outcomes (2)

• Proportion of subjects achieving clinical remission

  Week 12 post-Fluconazole Initiation

• Proportion of patients achieving endoscopic response or remission

  Up to 1 Year post-Fluconazole Initiation

Study Arms (2)

IL-23 Therapy with Fluconazole

EXPERIMENTAL

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.

Drug: Fluconazole; Biological: IL-23 Therapy

IL-23 Therapy with Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Biological: IL-23 Therapy

Interventions

Fluconazole DRUG

Oral fluconazole capsules.

Also known as: Diflucan

IL-23 Therapy with Fluconazole

Placebo DRUG

Oral placebo capsules will be used as a comparator.

IL-23 Therapy with Placebo

IL-23 Therapy BIOLOGICAL

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

Also known as: Risankizumab, Ustekinumab, Guselkumab

IL-23 Therapy with Fluconazole; IL-23 Therapy with Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years old
• Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450

You may not qualify if:

• 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
• Pregnant or lactating women
• Severe Crohn's disease defined by a PRO-2 score ≥ 34 or imminent need for surgery, or deemed not medically fit by physician
• Patient with symptomatic stricturing
• Patient with pouchitis or an ostomy
• Patients with known, active fungal infection(s) since these patients would require particular, standard-of-care monitoring and treatment, which may include intravenous and/or prolonged courses of fluconazole or other therapies.
• Patients with hypokalemia, or advanced cardiac failure
• Patients with renal insufficiency

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Fluconazole; risankizumab; Ustekinumab; guselkumab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Randy Longman, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Ericsson, BS

CONTACT

646-697-0985; cae4007@med.cornell.edu

Aurelia Li, BS

CONTACT

646-697-0985; aul4004@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 23, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)