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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06274554
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fluconazole — DRUG
    Oral fluconazole capsules.
  • Placebo — DRUG
    Oral placebo capsules will be used as a comparator.
  • IL-23 Therapy — BIOLOGICAL
    Risankizumab (IL-23), Guselkumab (IL-23), or Ustekinumab (IL-12/23) as standard of care treatment.

Study Details

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.

Key Dates

Start date
Oct 4, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Caroline Ericsson, BS
[email protected]
646-697-0985
Aurelia Li
[email protected]
Randy Longman, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dana Lukin, MD, PhD (SUB_INVESTIGATOR)
Ellen Scherl, MD (SUB_INVESTIGATOR)
Iliyan Iliev, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Weill Cornell Medicine· New York, NY

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