Loading clinical trials...

Pilot Study of Posaconazole in Crohn's Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE4

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

NCT04966585•Cedars-Sinai Medical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (2)

Cedars-Sinai Medical Center (CSMC)

Los Angeles, California, United States

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

August 17, 2022

Primary Completion Date

January 22, 2025

Completion Date

January 22, 2025

Last Updated

February 24, 2026

Enrollment

ACTUAL participants

Conditions

Crohn DiseaseCARD9 S12N Risk Allele

Interventions

Posaconazole Delayed Release Oral Tablet

DRUG

Matching Placebo Tablet

DRUG

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

NCT07245394

Inflammatory Bowel Disease (IBD)Crohn Disease (CD)+2 more

View study

RECRUITING

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

NCT07089420

IBD (Inflammatory Bowel Disease)IBS - Irritable Bowel Syndrome+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pilot Study of Posaconazole in Crohn's Disease

Inclusion Criteria

Exclusion Criteria

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

Immunological Characteristics of Preclinical IBD

Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study