Antifungal drug targets gut fungus in Crohn's patients with genetic risk
NCT ID NCT04966585
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study tested the antifungal drug posaconazole in people with active Crohn's disease who carry a specific gene variant (CARD9 S12N). The goal was to see if reducing a type of fungus in the gut could lower inflammation and improve symptoms. The trial was stopped early and included only 10 participants.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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10 people
The number who actually took part.
- Started
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Aug 2022
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * Subjects receiving oral aminosalicylates (at a stable dose for 2 weeks prior to baseline), immunomodulators (at a stable dose for 4 weeks prior to baseline), anti-TNF, anti IL12/23, or anti-integrin therapy (at stable maintenance doses for \> 8 weeks) may continue their use during the study. * Subjects receiving oral corticosteroids may continue their use during the study provided the dose (prednisone up to 20 mg/day, budesonide up to 9 mg/day) has been stable for two weeks prior to screening. * Have had age-appropriate and disease-duration-appropriate colon cancer screening1 without unresected dysplasia. * Women of childbearing age, excluding those with prior bilateral tubal ligation or at least one-year post-menopause, must not be pregnant, lactating, or planning to become pregnant. They must agree to use effective contraception throughout the study period. * Subjects must be able to provide informed consent and understand, agree with, and be able to adhere to daily diary entries, all scheduled visits, tests, procedures, and protocol in English. Exclusion Criteria: * Known hypersensitivity or allergy to posaconazole or other azole antifungal agents * Concomitant medications primarily metabolized by CY3PA4 including: a) Hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors, primarily metabolized by CY3PA4 (increases risk of rhabdomyolysis), b) Sirolimus, c) Ergot alkaloids, d) vincristine * Proarrhythmic conditions * Moderate or severe renal impairment (Cr Clearance \<50) * Current diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, infectious colitis, or microscopic colitis. * Fulminant colitis, toxic megacolon, peritonitis, ileostomy or colostomy. * Stool sample positive for pathogens including ova and parasites, Salmonella, Shigella, and C. difficile at screening. * History of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease or any other medical condition that, in the Investigators opinion, would prevent the subject from participation in the study. * Treatment with antibiotics, antifungal agents, probiotics, or prebiotics within two weeks of screening. * Alcohol or drug abuse (in the opinion of the Investigator) that would interfere with compliance. * Any other investigational therapy or treatment within four weeks of screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedars-Sinai Medical Center (CSMC)
Los Angeles, California, 90048, United States
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Mayo Clinic
Rochester, Minnesota, 55901, United States
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