Crohn's DiseasePhase 3FUN-CDNCT06274554
Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease
A Phase 3 study testing Fluconazole and IL-23 Therapy in people with Crohn's Disease and Inflammatory Bowel Diseases, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Inflammatory Bowel Diseases
- What is being tested?
- Fluconazole and IL-23 Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2024to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at least 18 years old
- Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Emely Fernandez, BS, 646-697-0985, emf4006@med.cornell.edu
Aurelia Li, aul4004@med.cornell.edu
About this study
Official title: 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
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.
Read the detailed description
The purpose of this study is to examine the efficacy and safety of fluconazole in combination with IL-23 therapy versus IL-23 therapy alone for the treatment of Crohn's disease (CD). IL-23 therapy may include ustekinumab (anti-interleukin-12/23), risankizumab (anti-interleukin-23), or guselkumab (anti-interleukin-23).
Subjects will be stratified into two groups based on standard of care treatment: IL-23 therapy initiation or IL-23 therapy dose escalation. Subjects in each group will then be randomized to one of two treatment arms:
- IL-23 Therapy with Fluconazole (200 mg on Day 0 and 100 mg on Days 1-13)
- IL-23 Therapy with Placebo (200 mg on Day 0 and 100 mg on Days 1-13)
Subjects will blindly receive the fluconazole treatment only if they meet all inclusion and exclusion criteria. They will have an ancillary visit at Weill Cornell or a local laboratory of their choosing 2 weeks post-treatment initiation. Subjects will also return for a standard of care clinic visit 12 weeks post-treatment initiation. Disease activity will be assessed at standard of care visits. Stool, blood, and oral swab samples will collected for research from subjects at Day 0 (pre-treatment initiation) and Week 12 post-treatment initiation. Subjects may also opt in to provide these samples at Week 2 post-treatment initiation and Week 8 post-treatment initiation. If subjects consent to biopsies, biopsies will also be collected for research at endoscopic procedures (colonoscopies and/or flexible sigmoidoscopies). Subjects may opt in to return at Week 24 and 1 year post-treatment initiation for standard of care visits, where blood, stool, and oral swabs would also be collected for research.
- Conditions
- Crohn's Disease, Inflammatory Bowel Diseases
- Being tested
- Fluconazole, Placebo, IL-23 Therapy
- Keywords
- Fluconazole, IL-23
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
Also called Diflucan
Oral fluconazole capsules.
PlaceboDrug
Oral placebo capsules will be used as a comparator.
IL-23 TherapyBiological
Also called Risankizumab, Ustekinumab, Guselkumab
Risankizumab (IL-23), Guselkumab (IL-23), or Ustekinumab (IL-12/23) as standard of care treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo; Biological: IL-23 Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12 post-Fluconazole Initiation
Secondary outcomes (2)
Proportion of subjects achieving clinical remission
Participants achieving clinical remission are those participants with a Crohn's Disease Activity Index (CDAI) score of no greater than 150 points at week 12 post-Fluconazole initiation.
Measured: Week 12 post-Fluconazole Initiation
Proportion of patients achieving endoscopic response or remission
Participants achieving endoscopic response are those participants with a reduction in the Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from baseline. Participants achieving endoscopic remission are those participants with an SES-CD score less than or equal to 2
Measured: Up to 1 Year post-Fluconazole Initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start4 Oct 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Sponsor
- Investigators
- Randy Longman, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274554
- Sponsor's protocol ID
- 23-11026746
- Acronym
- FUN-CD
- Status last verified
- Aug 2026
- First submitted
- 15 Feb 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06274554
- Acronym / sponsor ID
- FUN-CD / 23-11026746
- Conditions
- Crohn's Disease, Inflammatory Bowel Diseases
- Keywords
- Fluconazole, IL-23
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to examine the efficacy and safety of fluconazole in combination with IL-23 therapy versus IL-23 therapy alone for the treatment of Crohn's disease (CD). IL-23 therapy may include ustekinumab (anti-interleukin-12/23), risankizumab (anti-interleukin-23), or guselkumab (anti-interleukin-23).
Subjects will be stratified into two groups based on standard of care treatment: IL-23 therapy initiation or IL-23 therapy dose escalation. Subjects in each group will then be randomized to one of two treatment arms:
- IL-23 Therapy with Fluconazole (200 mg on Day 0 and 100 mg on Days 1-13)
- IL-23 Therapy with Placebo (200 mg on Day 0 and 100 mg on Days 1-13)
Subjects will blindly receive the fluconazole treatment only if they meet all inclusion and exclusion criteria. They will have an ancillary visit at Weill Cornell or a local laboratory of their choosing 2 weeks post-treatment initiation. Subjects will also return for a standard of care clinic visit 12 weeks post-treatment initiation. Disease activity will be assessed at standard of care visits. Stool, blood, and oral swab samples will collected for research from subjects at Day 0 (pre-treatment initiation) and Week 12 post-treatment initiation. Subjects may also opt in to provide these samples at Week 2 post-treatment initiation and Week 8 post-treatment initiation. If subjects consent to biopsies, biopsies will also be collected for research at endoscopic procedures (colonoscopies and/or flexible sigmoidoscopies). Subjects may opt in to return at Week 24 and 1 year post-treatment initiation for standard of care visits, where blood, stool, and oral swabs would also be collected for research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IL-23 Therapy with Fluconazole | Experimental | Drug: Fluconazole, Biological: IL-23 TherapyFluconazole 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. |
| IL-23 Therapy with Placebo | Placebo comparator | Drug: Placebo, Biological: IL-23 TherapyPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients at least 18 years old
- Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluconazoleAlso: DiflucanOral fluconazole capsules. | Drug | IL-23 Therapy with Fluconazole |
| PlaceboOral placebo capsules will be used as a comparator. | Drug | IL-23 Therapy with Placebo |
| IL-23 TherapyAlso: Risankizumab, Ustekinumab, GuselkumabRisankizumab (IL-23), Guselkumab (IL-23), or Ustekinumab (IL-12/23) as standard of care treatment. | Biological | IL-23 Therapy with Fluconazole, IL-23 Therapy with Placebo |
Primary outcome
Proportion of subjects achieving clinical response
Time frame: Week 12 post-Fluconazole Initiation
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.
2 secondary outcomes
Proportion of subjects achieving clinical remission
Time frame: Week 12 post-Fluconazole Initiation
Proportion of patients achieving endoscopic response or remission
Time frame: Up to 1 Year post-Fluconazole Initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Randy Longman, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluconazole and IL-23 Therapy in people with Crohn's Disease and Inflammatory Bowel Diseases, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emely Fernandez, BS (646-697-0985, emf4006@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving clinical response (time frame: Week 12 post-Fluconazole Initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.