NCT04966585

Pilot Study of Posaconazole in Crohn's Disease

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This trial is designed to evaluate the effects of oral antifungal treatment with posaconazole on active Crohn's disease (CD) activity and the burden of Malassezia spp. in CD patients with the caspase recruitment domain family member 9 (CARD9) S12N risk allele. Further, this project will investigate the hypothesis that the microbial changes induced by antifungal treatment are associated with dampened downstream immune responses in those with a genetic predisposition to developing strong immune responses to Malassezia.

Conditions

• Crohn Disease
• CARD9 S12N Risk Allele

Interventions

Type	Name	Description
DRUG	Posaconazole Delayed Release Oral Tablet	Three 100mg delayed-release tablets twice a day on the first day, then three 100mg delayed-release tablets once a day, starting on the second day. Duration of therapy will be 12 weeks.
DRUG	Matching Placebo Tablet	Three matching placebo tablets twice a day on the first day, then three tablets once a day, starting on the second day. Duration of therapy will be 12 weeks.

Timeline

• Start date: 2022-08-17
• Primary completion: 2025-01-22
• Completion: 2025-01-22
• First posted: 2021-07-19
• Last updated: 2026-02-24
• Results posted: 2026-02-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study