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Antifungal
Posaconazole for Crohn's Disease
Phase 4
Recruiting
Led By Gil Y Melmed, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
Moderate or severe renal impairment (Cr Clearance <50)
Proarrhythmic conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
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.
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Posaconazole may cause headaches, nausea, stomach pain, diarrhea, fever; it might also affect liver enzymes and interact with other drugs. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have active Crohn's disease confirmed by a scope test and symptoms.
Select...
I have a specific genetic variation linked to increased disease risk.
Select...
I have Crohn's disease affecting my ileum or colon for at least 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is reduced with a creatinine clearance below 50.
Select...
I do not have a heart condition that can cause irregular heartbeats.
Select...
I have severe colon issues, including toxic megacolon or need for a stoma.
Select...
I have been diagnosed with a type of colitis.
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I am not taking drugs that are mainly processed by the liver enzyme CY3PA4.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Endoscopic Response
Secondary study objectives
Induction of Clinical Remission
Proportion of subjects in endoscopic remission
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Crohn's Disease include biological agents and antifungal treatments. Biological agents, such as anti-TNF agents (e.g., infliximab, adalimumab), work by inhibiting tumor necrosis factor-alpha (TNF-α), a key cytokine in inflammation.
Other agents like ustekinumab target interleukins (IL-12 and IL-23) to reduce inflammatory responses. The antifungal treatment with Posaconazole aims to reduce the burden of Malassezia spp., potentially dampening immune responses in genetically predisposed individuals.
These treatments are crucial as they target specific inflammatory pathways and microbial factors, offering tailored approaches to reduce inflammation and manage Crohn's Disease activity.
Review article: biological agents in the treatment of Crohn's disease.
Review article: biological agents in the treatment of Crohn's disease.
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
512 Previous Clinical Trials
163,340 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,456 Previous Clinical Trials
4,335,107 Total Patients Enrolled
Gil Y Melmed, MDPrincipal InvestigatorCedars-Sinai Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking drugs that are mainly processed by the liver enzyme CY3PA4.I have active Crohn's disease confirmed by a scope test and symptoms.I am 18 years old or older.I don't have any major health issues that would stop me from joining the study.I have a specific genetic variation linked to increased disease risk.My kidney function is reduced with a creatinine clearance below 50.I do not have a heart condition that can cause irregular heartbeats.I have severe colon issues, including toxic megacolon or need for a stoma.I have been diagnosed with a type of colitis.I haven't taken antibiotics, antifungals, probiotics, or prebiotics in the last two weeks.I have Crohn's disease affecting my ileum or colon for at least 6 months.I've been on stable doses of certain medications for my condition for weeks.I have been on a stable dose of oral corticosteroids for at least two weeks.I am not pregnant, breastfeeding, or planning to become pregnant and agree to use contraception if of childbearing age.I've had the right colon cancer checks for my age and disease stage, with no untreated abnormal growths.
Research Study Groups:
This trial has the following groups:- Group 1: Posaconazole
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.