Posaconazole for Crohn's Disease

This trial examines how the oral antifungal posaconazole affects individuals with active Crohn's disease, particularly those with the CARD9 S12N risk allele, which may enhance immune responses. Researchers aim to determine if this treatment can reduce Crohn's disease activity and the presence of the yeast Malassezia in the gut. Participants will receive either posaconazole or a placebo (a pill with no active drug) for 12 weeks. Suitable candidates have had Crohn's disease for at least 6 months, experience active symptoms, and possess the specified genetic trait. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for more patients.

You can continue taking certain medications like oral aminosalicylates, immunomodulators, anti-TNF, anti IL12/23, anti-integrin therapy, and oral corticosteroids if they have been stable for a specified period before the trial. However, you cannot take medications primarily metabolized by CY3PA4, antibiotics, antifungal agents, probiotics, or prebiotics within two weeks of screening.

Research has shown that posaconazole is commonly used to treat and prevent fungal infections, and studies have found it effective. Participants should know that posaconazole is usually well-tolerated, with most people experiencing only mild side effects like nausea, headache, or diarrhea.

Most treatments for Crohn's disease, like biologics and immunosuppressants, aim to control inflammation by suppressing the immune system. But posaconazole works differently, targeting fungal infections that might be contributing to the disease's progression. Unlike typical options, posaconazole is an antifungal agent, not an immunosuppressant, which means it may offer relief without the side effects associated with weakening the immune system. Researchers are excited about this treatment because it represents a novel approach that could provide an alternative for patients who don't respond well to existing therapies.

Research has shown that posaconazole effectively treats various fungal infections. It prevents and treats these infections in individuals with weakened immune systems, such as those with acute myeloid leukemia. However, strong evidence does not yet support posaconazole's effectiveness for Crohn's Disease. In this trial, participants will receive either posaconazole or a placebo to study its potential effects on Crohn's Disease, particularly in patients with a specific genetic risk factor. The medicine's ability to alter fungal levels and immune responses could potentially benefit these patients.¹²³⁵⁶