Posaconazole in Genetically Defined Patients with CD

What is the Purpose of this Study?

This study focuses on individuals who have been diagnosed with Crohn's disease and are at risk for fungal infection based on genetic determination. The purpose of the study is to evaluate the effects of oral posaconazole for the treatment of active Crohn's disease in a genetically defined population. Posaconazole is approved by the U.S. Food and Drug Administration (FDA) for the treatment of fungal infections, but its use in this study is experimental. The main procedures of the study include physical exams, laboratory tests, colonoscopy with biopsies, EKG, chest X-rays, questionnaires, and a daily diary. Participants will be randomly assigned to one of two groups: one group will receive the treatment (posaconazole), and the other will receive placebo (inactive substance). Samples will also be obtained throughout the study for biomarker testing. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease; biomarkers are good indicators of treatment response.


Eligibility

  • * Male or female patients aged 18 years and older, inclusive based on the date of the screening visit.
  • * A diagnosis of CD with minimum disease duration of 6 months with involvement of the ileum and/or colon documented on colonoscopy
  • * Have an endoscopically-confirmed active Crohn's disease with active disease defined by SES-CD \> 6 (\>4 if ileal only), AND active symptoms of Crohn's disease (CDAI score \>220)
  • * Homozygous for CARD9 S12N risk allele, without the protective exon 11 polymorphism
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Multicenter Randomized, Double-Blinded, Placebo-Controlled Study of Posaconazole in Genetically-Defined Patients with Active Crohn's Disease.

Study Details
Disease Type/Condition

Inflammatory Bowel Disease

Principal Investigator

Melmed, Gil

Co-Investigators

David Underhill

Age Group

Adult

Phase

I/II

IRB Number

STUDY00000256

ClinicalTrials.gov ID

NCT04966585

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Inflammatory Bowel Disease

Principal Investigator

Melmed, Gil

Age Group

Adult

Phase

I/II

IRB Number

STUDY00000256

ClinicalTrials.gov ID

NCT04966585

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org