ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Researchers are testing whether targeting fungi with fluconazole can boost how well IL-23 biologics work for Crohn’s disease — if positive, this could point to a new adjunctive strategy to improve responses to biologic therapy.
Who Should Pay Attention
Adults with Crohn’s disease starting or escalating IL-23 biologic therapy; clinicians who prescribe IL-23 biologics; researchers studying the microbiome and IBD treatment strategies.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 3
Enrollment120 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a randomized, placebo-controlled add-on trial enrolling about 120 adults who are either starting an IL-23 therapy or having their IL-23 dose escalated.
Participants are randomized to a 14-day oral course of fluconazole (200 mg day 0, then 100 mg daily for 13 days) versus matched placebo, with primary outcome measured as proportion achieving a CDAI reduction ≥100 at week 12.
The study collects stool, blood, and oral swabs (and optional biopsy samples during clinical endoscopies) for research at baseline and week 12, with optional additional sampling at weeks 2, 8, 24, and 52.
Key exclusions include recent antifungal use, known hepatic disease, interacting medications, pregnancy, severe Crohn's features (including symptomatic strictures), active fungal infections, and ostomy/pouchitis.
If you’re considering participation, discuss with your clinician whether you meet eligibility and how the trial’s short antifungal course and monitoring fit your situation.
Keep In Mind
This is a Phase 3 interventional trial that is currently recruiting at Weill Cornell; it tests a short, fixed-duration fluconazole course as an adjunct to standard-of-care IL-23 agents. The record describes study design and eligibility but does not report results.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorWeill Medical College of Cornell University
Trial IDNCT06274554
Study typeInterventional
Trial phasePhase 3
Enrollment120 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 20, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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