A Study to Evaluate Posaconazole to Treat Genetically-defined Patients with Active Crohn's Disease

Overview

About this study

The purpose of this study is to evaluate the effects of oral antifungal treatment with posaconazole on disease activity and the burden of Malassezia spp. in CD patients with the CARD9 S12N 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.  

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female patients, aged 18 to 60 years, 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 > 220).
  • 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.  Lab findings of hypokalemia, hypomagnesemia, or hypocalcemia are eligible, provided electrolyte abnormalities are corrected and stable prior to study enrollment.
  • 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 screening* 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:
    • HMG-CoA inhibitors primarily metabolized by CY3PA4 (increases risk of rhabdomyolysis);
    • Sirolimus;
    • Ergot alkaloids;
    • 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, probiotics, or prebiotics within two weeks of screening.
  • Alcohol or drug abuse (in the opinion of the Investigator) that would interfere with compliance.

Eligibility last updated 4/4/22. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Laura Raffals, M.D.

Open for enrollment

Contact information:

Chad Rypstra

(507) 538-4289

Rypstra.Chad@mayo.edu

More information

Publications

Publications are currently not available
.

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