Posaconazole in Genetically Defined Patients with CD

Condition: Crohn's disease

Eligibility

Key Inclusion Criteria:

  • 18-60 years old
  • Diagnosis of Crohn’s disease with minimum disease duration of 6 months with involvement of the ileum and/or colon, documented on colonoscopy
  • Endoscopically confirmed, active Crohn’s disease

Key Exclusion Criteria:

  • Known hypersensitivity or allergy to posaconazole or other azole antifungal agents
  • Concomitant medications primarily metabolized by CY3PA4
  • Proarrhythmic conditions

Full Study Name

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Posaconazole in Genetically Defined Patients With Active Crohn's Disease (IRB no. 00000256)

Summary

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.

Principal Investigator