Posaconazole for Crohn's Disease
Recruiting in Palo Alto (17 mi)
+1 other location
GY
Overseen byGil Y Melmed, MD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Cedars-Sinai Medical Center
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial is testing an oral antifungal medication to help Crohn's disease patients with a specific genetic marker. The medication aims to reduce a type of fungus in the body, which may calm the immune system and improve symptoms.
Do I have to stop taking my current medications for the trial?
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.
What data supports the idea that Posaconazole for Crohn's Disease is an effective drug?
The available research does not provide any data supporting the effectiveness of Posaconazole for Crohn's Disease. The articles focus on other treatments and diagnostic agents for different conditions, such as prostate cancer and ulcerative colitis, but do not mention Posaconazole or its impact on Crohn's Disease.12345
What safety data is available for Posaconazole?
Posaconazole, also known as Noxafil, is a triazole antifungal agent with an established safety profile for the treatment and prophylaxis of invasive fungal infections. It is approved for use in adults and has been studied in various formulations, including oral suspension, gastro-resistant tablets, and intravenous solutions. The drug is generally well-tolerated, but proper administration is crucial to avoid subtherapeutic levels, as highlighted by a case where improper use led to treatment failure. Posaconazole has been shown to be effective against a wide range of fungal pathogens, often outperforming other antifungal agents in vitro.678910
Research Team
GY
Gil Y Melmed, MD
Principal Investigator
Cedars-Sinai Medical Center
Eligibility Criteria
Adults aged 18-60 with Crohn's Disease affecting the ileum/colon, carrying a specific genetic risk (CARD9 S12N allele), can join this trial. They must have stable disease treatments and agree to contraception if applicable. Excluded are those allergic to azoles, with severe colitis or organ issues, recent drug/alcohol abuse, or on certain medications.Inclusion Criteria
I have active Crohn's disease confirmed by a scope test and symptoms.
I am 18 years old or older.
I have a specific genetic variation linked to increased disease risk.
See 6 more
Exclusion Criteria
I am not taking drugs that are mainly processed by the liver enzyme CY3PA4.
I don't have any major health issues that would stop me from joining the study.
Alcohol or drug abuse (in the opinion of the Investigator) that would interfere with compliance
See 8 more
Treatment Details
Interventions
- Matching Placebo Tablet (Other)
- Posaconazole (Antifungal)
Trial OverviewThe study tests Posaconazole against a placebo in Crohn's patients with a genetic predisposition. It aims to see if the antifungal treatment reduces disease activity and immune responses by altering gut microbes associated with Malassezia spp.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PosaconazoleExperimental Treatment1 Intervention
Subjects administered posaconazole (Noxafil®, Merck) 300mg twice daily for 1 day followed by 300mg daily for 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
Subjects administered three matching placebo tablets twice daily for 1 day followed by three tablets daily for 12 weeks
Posaconazole is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Noxafil for:
- Invasive Aspergillus infections
- Candidemia
- Oropharyngeal Candidiasis
🇺🇸 Approved in United States as Noxafil for:
- Invasive Aspergillus infections
- Candidemia
- Oropharyngeal Candidiasis
🇨🇦 Approved in Canada as Noxafil for:
- Invasive Aspergillus infections
- Candidemia
- Oropharyngeal Candidiasis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo ClinicRochester, MN
Cedars-Sinai Medical Center (CSMC)Los Angeles, CA
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Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor
Trials
523
Patients Recruited
165,000+
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Trials
2513
Patients Recruited
4,366,000+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Piflufolastat F 18: Diagnostic First Approval.Keam, SJ.[2022]
The novel [18F]AlF-PSMA-137 probe demonstrated high specificity and binding affinity to prostate-specific membrane antigen (PSMA), with a radiochemical purity over 99% and effective tumor imaging capabilities in both preclinical and clinical settings.
In a pilot study involving 13 patients, [18F]AlF-PSMA-137 successfully detected 81 lesions, showing significant increases in tumor uptake over time, indicating its potential as an effective tool for diagnosing prostate cancer.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Preclinical evaluation and first in human study of Al18F radiolabeled ODAP-urea-based PSMA targeting ligand for PET imaging of prostate cancer.Ren, Y., Liu, C., Liu, T., et al.[2022]
In a study involving three patients with inflammatory bowel disease (IBD), the PSMA-targeted imaging agent [18F]DCFPyL successfully identified areas of active inflammation in the gastrointestinal tract, correlating with endoscopic and histological findings.
The results suggest that [18F]DCFPyL PET imaging could serve as a valuable non-invasive tool for assessing the location and extent of inflammation in IBD, potentially improving disease management.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
PSMA-Targeted PET Radiotracer [18F]DCFPyL as an Imaging Biomarker in Inflammatory Bowel Disease.Ismail, MS., Peters, DE., Rowe, SP., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Flotufolastat F 18: Diagnostic First Approval.Heo, YA.[2023]
In a study of 18 patients with active ulcerative colitis (UC), single-needle granulocyte monocyte adsorption (SN-GMA) treatment led to a significantly higher clinical remission rate in patients who had not previously used corticosteroids (90.9%) compared to those who had (42.9%).
The study also found that SN-GMA was more effective in removing leukocytes and granulocytes from the blood in corticosteroid-naïve patients, suggesting that SN-GMA may be a more effective treatment option for these patients.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Comparison of adsorption efficiency of leukocytes in single needle GMA with or without PSL treatment in patients with active ulcerative colitis.Noguchi, Y., Shimazu, K., Totani, T., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Posaconazole: SCH 56592.[2019]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Posaconazole: a review of the gastro-resistant tablet and intravenous solution in invasive fungal infections.McKeage, K.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Magnetic resonance imaging assessment of the ventricular system in the brains of adult and juvenile beagle dogs treated with posaconazole IV Solution.Hines, CD., Song, X., Kuruvilla, S., et al.[2015]
Posaconazole is an effective antifungal medication for preventing Candida and Aspergillus infections in immunocompromised patients, but it must be taken with food to ensure proper absorption and effectiveness.
In a case study of a 49-year-old woman with acute myeloid leukemia, failure to adhere to the recommended administration guidelines for posaconazole likely contributed to her severe invasive sinus infection and subsequent death, highlighting the critical need for patient education on medication use.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Breakthrough invasive fungal infection in an immunocompromised host while on posaconazole prophylaxis: an omission in patient counseling and follow-up.Kishel, JJ., Sivik, J.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
In vitro activities of posaconazole, fluconazole, itraconazole, voriconazole, and amphotericin B against a large collection of clinically important molds and yeasts.Sabatelli, F., Patel, R., Mann, PA., et al.[2022]
In a study of 8 patients with Fanconi anemia (FA) treated with danazol, 7 patients showed significant improvements in hemoglobin and platelet counts, with increases of over 50% within 6 months, and these improvements were maintained for up to 3 years.
Danazol was well-tolerated, with no severe side effects leading to treatment discontinuation, suggesting it could be a safe and effective option for managing bone marrow failure in FA patients.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Treatment of the bone marrow failure in Fanconi anemia patients with danazol.Scheckenbach, K., Morgan, M., Filger-Brillinger, J., et al.[2013]
In a study of 76 patients with chronic aplastic anemia, the combination of compound Zaofan pill with cyclosporine and androgen resulted in a significantly higher cure and response rate (44.7%) compared to cyclosporine and androgen alone (15.8%).
The treatment with compound Zaofan pill also led to a notable increase in bone marrow microvessel density (MVD) and vascular endothelial growth factor (VEGF) levels, suggesting that it enhances the bone marrow environment, which is crucial for improving treatment outcomes.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Effect of Compound Zaofan Pill on Bone Marrow MVD and VEGF of Patients with Chronic Aplastic Anemia].Yang, FF., Wang, KW., Xiang, Q., et al.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A study to determine the effects of food and multiple dosing on the pharmacokinetics of vorinostat given orally to patients with advanced cancer.Rubin, EH., Agrawal, NG., Friedman, EJ., et al.[2018]
In a study of 25 patients with aplastic anemia (AA), Danazol treatment significantly increased the percentage of T regulatory cells (T-regs), which are important for immune regulation, compared to baseline levels.
Danazol was found to be effective in raising T-reg levels in AA patients, showing a greater increase than standard immunosuppressive treatments, suggesting its potential role in improving immune function in this condition.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Danazol increases T regulatory cells in patients with aplastic anemia.Khurana, H., Malhotra, P., Sachdeva, MU., et al.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Treatment of Chronic Aplastic Anemia with Chinese Patent Medicine Pai-Neng-Da Capsule () for Replacing Androgen Partially: A Clinical Multi-Center Study.Jiang, ZY., Yu, FQ., Gao, RL., et al.[2022]
References
Piflufolastat F 18: Diagnostic First Approval. [2022]
Preclinical evaluation and first in human study of Al18F radiolabeled ODAP-urea-based PSMA targeting ligand for PET imaging of prostate cancer. [2022]
PSMA-Targeted PET Radiotracer [18F]DCFPyL as an Imaging Biomarker in Inflammatory Bowel Disease. [2023]
Flotufolastat F 18: Diagnostic First Approval. [2023]
Comparison of adsorption efficiency of leukocytes in single needle GMA with or without PSL treatment in patients with active ulcerative colitis. [2023]
Posaconazole: SCH 56592. [2019]
Posaconazole: a review of the gastro-resistant tablet and intravenous solution in invasive fungal infections. [2018]
Magnetic resonance imaging assessment of the ventricular system in the brains of adult and juvenile beagle dogs treated with posaconazole IV Solution. [2015]
Breakthrough invasive fungal infection in an immunocompromised host while on posaconazole prophylaxis: an omission in patient counseling and follow-up. [2021]
In vitro activities of posaconazole, fluconazole, itraconazole, voriconazole, and amphotericin B against a large collection of clinically important molds and yeasts. [2022]
Treatment of the bone marrow failure in Fanconi anemia patients with danazol. [2013]
[Effect of Compound Zaofan Pill on Bone Marrow MVD and VEGF of Patients with Chronic Aplastic Anemia]. [2018]
A study to determine the effects of food and multiple dosing on the pharmacokinetics of vorinostat given orally to patients with advanced cancer. [2018]
Danazol increases T regulatory cells in patients with aplastic anemia. [2018]
Treatment of Chronic Aplastic Anemia with Chinese Patent Medicine Pai-Neng-Da Capsule () for Replacing Androgen Partially: A Clinical Multi-Center Study. [2022]