Crohn's Disease · Inflammatory Bowel Diseases
Fluconazole With IL-23 Therapy for Adults With Crohn’s Disease
This randomized study asks whether adding fluconazole to interleukin-23 (IL-23) therapy affects treatment response and safety in adults with mild to moderate Crohn’s disease who are starting or escalating IL-23 therapy.
Registry title: Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- Fluconazole or Placebo
- Design
- Randomized · Double
- Central study contact
- Emely Fernandez, BS646-697-0985emf4006@med.cornell.edu
- Sponsor
- Weill Medical College of Cornell University
Research question
Does adding a 14-day course of fluconazole to IL-23 therapy change clinical response or safety compared with IL-23 therapy plus placebo in people with Crohn’s disease?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older.
- The study is looking for people with mild to moderate Crohn’s disease, defined by a Crohn’s Disease Activity Index score of 150–450.
- The study is looking for people planning to start IL-23 therapy or currently receiving it and planning a dose increase.
- The listed recruiting location is Weill Cornell Medicine in New York City.
Participation overview
What participation may involve
Participants continue standard-of-care IL-23 therapy and take either fluconazole or placebo for 14 days. Required research samples are described at Day 0 and Week 12, with additional optional sampling and follow-up. What participation may involve: - Take blinded oral fluconazole or placebo for 14 days. - Attend an ancillary visit at Weill Cornell or a chosen local laboratory two weeks after treatment begins. - Return for a standard-of-care clinic visit at Week 12, when disease activity is assessed. - Provide stool, blood, and oral swab samples for research at Day 0 and Week 12. - Participants may optionally provide additional samples at Weeks 2 and 8 and attend follow-up visits with research sampling at Week 24 and one year. - Participants who consent may have research biopsies collected during colonoscopy or flexible sigmoidoscopy procedures. The blinded fluconazole or placebo course lasts 14 days; required activities are described through Week 12, and optional follow-up may extend to one year. The record describes a two-week ancillary visit and a Week 12 standard-of-care visit, plus optional visits at Week 24 and one year; it does not give a complete visit count.
Study interventions
What participants may receive or do
- Fluconazole: Participants assigned to this group take oral fluconazole capsules: 200 mg on Day 0, followed by 100 mg once daily on Days 1–13.
- Placebo: Participants assigned to the comparison group take oral placebo capsules using the same reported dose schedule: 200 mg on Day 0 and 100 mg once daily on Days 1–13.
- IL-23 Therapy: All participants receive standard-of-care therapy involving risankizumab, guselkumab, or ustekinumab, either when starting treatment or when escalating its dose.
Study design
How the comparison works
This Phase 3, parallel-group treatment study assigns participants to IL-23 therapy with either fluconazole or placebo and plans to enroll 120 people. Participants are randomized after being grouped according to whether they are starting IL-23 therapy or escalating its dose. The study is double-blinded: participants and investigators are masked to whether fluconazole or placebo is assigned. The comparison group receives IL-23 therapy plus oral placebo, while the experimental group receives IL-23 therapy plus oral fluconazole. The placebo is given as oral capsules on the same reported 14-day schedule as fluconazole.
Reported activities
Procedures and tests
- Crohn’s disease activity is assessed during standard-of-care visits.
- Clinical response is evaluated at Week 12 using the Crohn’s Disease Activity Index (CDAI).
- Clinical remission is evaluated at Week 12 using the CDAI.
- Endoscopic response or remission is evaluated using the Simple Endoscopic Score for Crohn’s Disease.
- Stool, blood, and oral swab samples are collected for research at Day 0 and Week 12.
- Additional stool, blood, and oral swab collection at Weeks 2 and 8 is optional.
- Research biopsies may be collected during colonoscopy or flexible sigmoidoscopy if the participant separately consents.
- Baseline liver biochemistry may need to be confirmed because specified elevations are exclusion criteria.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be at least 18 years old.
- Participants must have mild to moderate Crohn’s disease, defined by a CDAI score of 150–450.
Possible reasons someone may not be able to join
- Antifungal use during the month before blinded fluconazole begins is not allowed.
- People with a known fluconazole allergy are excluded.
- Known liver disease, cirrhosis, or specified liver-test elevations at baseline may exclude a person, except confirmed Gilbert’s disease as stated.
- People taking medications that their clinical provider judges to be contraindicated interactions with fluconazole are excluded.
- Pregnant or lactating women are excluded.
- Severe Crohn’s disease—defined as a PRO-2 score of at least 34, imminent need for surgery, or being judged medically unfit by a physician—is excluded.
- People with symptomatic stricturing are excluded.
- People with pouchitis or an ostomy are excluded.
- People with a known active fungal infection are excluded.
- People with low potassium or advanced heart failure are excluded.
- People with renal insufficiency are excluded; the registry does not state a numerical threshold.
Important unknowns
What the record does not make clear
- The record states that assignment is randomized but does not report the allocation ratio or each participant’s probability of receiving placebo.
- Several scheduled and optional visits are described, but the record does not provide a complete visit count or distinguish every research visit from standard care.
- The blinded treatment lasts 14 days and required activities are described through Week 12, but the record does not explicitly state each participant’s total required study duration.
- The record names three possible standard-of-care IL-23 therapies but does not fully describe how the specific drug and initiation or dose-escalation plan are selected for each participant.
- A one-month restriction is stated for antifungal use, but the record does not provide a complete list of medication restrictions or timing requirements.
- The record does not describe rescue treatment or what happens if Crohn’s disease worsens during the study.
- Research biopsies are optional when endoscopic procedures occur, but the record does not clearly state whether any colonoscopy or flexible sigmoidoscopy is required by the study.
- The record does not state which study or standard-care costs are covered or billed to insurance.
- The record does not report whether participants are compensated.
- The record does not report reimbursement or assistance for transportation, lodging, or parking.
- The two-week visit may occur at a chosen local laboratory, but the record does not state whether any other activities can be completed remotely.
- The record does not describe access to fluconazole or study-related treatment after participation ends.
Before contacting the site
Questions for the study team
- What is the allocation ratio and my chance of receiving placebo?
- What is the complete required visit and testing schedule, and how long does required participation last?
- Which visits and laboratory collections can happen locally or remotely?
- Is an endoscopy required, or are optional biopsies collected only during an otherwise planned procedure?
- What happens if Crohn’s symptoms worsen, and what rescue treatment is permitted?
- Which medications must be stopped or adjusted beyond the one-month antifungal restriction?
- Which study costs are covered, what may be billed to insurance, and is compensation or travel support available?
- How is the specific IL-23 drug and initiation or dose-escalation plan chosen?
Before changing care
Questions for your gastroenterologist
- Would starting or escalating one of the listed IL-23 therapies fit my current disease activity and treatment history?
- Would any of my current medicines interact with fluconazole or need to be changed?
- How stable is my Crohn’s disease, and are stricturing, possible surgery, an ostomy, or pouchitis relevant to discussing this study?
- What approved treatment alternatives should I compare with starting or escalating IL-23 therapy in this study?
- How would you coordinate monitoring, routine Crohn’s care, and any worsening symptoms with the research team?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
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: 1. IL-23 Therapy with Fluconazole (200 mg on Day 0 and 100 mg on Days 1-13) 2. 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 and administration
- Organization
- Weill Medical College of Cornell University
- Organization class
- Other
- Organization study ID
- 23-11026746
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Double
- Who is masked
- Participant, Investigator
- Standard age groups
- Adult, Older Adult
Study 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.
Interventions: Drug: Fluconazole, Biological: IL-23 Therapy
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: Drug: Placebo, Biological: IL-23 Therapy
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.
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (2)
- Patients at least 18 years oldRegistry-derived · unreviewed
- Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450Registry-derived · unreviewed
Exclusion criteria (11)
- Antifungal usage within one month prior to initiation of blinded fluconazole usageRegistry-derived · unreviewed
- Known allergy to fluconazoleRegistry-derived · unreviewed
- 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 baselineRegistry-derived · unreviewed
- 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 QTcRegistry-derived · unreviewed
- Pregnant or lactating womenRegistry-derived · unreviewed
- Severe Crohn's disease defined by a PRO-2 score ≥ 34 or imminent need for surgery, or deemed not medically fit by physicianRegistry-derived · unreviewed
- Patient with symptomatic stricturingRegistry-derived · unreviewed
- Patient with pouchitis or an ostomyRegistry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Patients with hypokalemia, or advanced cardiac failureRegistry-derived · unreviewed
- Patients with renal insufficiencyRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
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.
Secondary outcome
Proportion of subjects achieving clinical remission
Time frame: Week 12 post-Fluconazole Initiation
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.
Secondary outcome
Proportion of patients achieving endoscopic response or remission
Time frame: Up to 1 Year post-Fluconazole Initiation
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
Recruiting locations in the United States
Weill Cornell Medicine
RecruitingNew York, New York, 10065, United States
Emely Fernandez, BS646-697-0985emf4006@med.cornell.edu
Aurelia Liaul4004@med.cornell.edu
Randy Longman, MD, PhD
Dana Lukin, MD, PhD
Ellen Scherl, MD
Iliyan Iliev, PhD
Central study contacts
Registry dates
- First posted
- Feb 23, 2024
- Primary completion
- Dec 2028
- Overall completion
- Dec 2029
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.