Recruiting
Phase 3

Fluconazole

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06274554

Conditions

Crohn's Disease

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluconazole

Placebo

IL-23 Therapy

Study Details

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

Study ID

NCT06274554

Start date

Oct 4, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Antifungal usage within one month prior to initiation of blinded fluconazole usage
2. Known allergy to fluconazole
3. 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
4. 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
5. Pregnant or lactating women
6. Severe Crohn's disease defined by a PRO-2 score ≥ 34 or imminent need for surgery, or deemed not medically fit by physician
7. Patient with symptomatic stricturing
8. Patient with pouchitis or an ostomy
9. 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.
10. Patients with hypokalemia, or advanced cardiac failure
11. Patients with renal insufficiency

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Fluconazole

Oral fluconazole capsules.

Placebo

Oral placebo capsules will be used as a comparator.

IL-23 Therapy

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

Primary outcome measure

  • Proportion of subjects achieving clinical response [ Time Frame: Week 12 post-Fluconazole Initiation ]

Central Contacts and Locations

Central contacts

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Principal Investigator:

Randy Longman, MD, PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Fluconazole
  • IL-23

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-20.