Pilot Study of Posaconazole in Crohn's Disease (NCT04966585) | Clinical Trial Compass
TerminatedPhase 4
Pilot Study of Posaconazole in Crohn's Disease
Stopped: Recruitment challenges; changes in manufacturing
United States10 participantsStarted 2022-08-17
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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 d…
What they're measuring
1
Number of Subjects With Medically Defined Endoscopic Response