What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease include antifungal agents like Posaconazole, glucocorticoids, thiopurines, biologics, and 5-aminosalicylates. Antifungal treatments can cause gastrointestinal upset, liver enzyme abnormalities, and allergic reactions. Glucocorticoids are associated with significant side effects such as weight gain, osteoporosis, hypertension, and increased infection risk. Thiopurines can lead to bone marrow suppression, liver toxicity, and increased risk of infections and malignancies. Biologics may cause infusion reactions, increased risk of infections, and potential development of antibodies against the drug. 5-aminosalicylates can cause gastrointestinal distress, headache, and rarely, kidney dysfunction.

What prior FDA approvals exist?

FDA-approved treatments for Crohn's Disease include several biologic agents targeting tumor necrosis factor-alpha (TNF-alpha) such as infliximab, adalimumab, and certolizumab pegol. Other biologics include vedolizumab, which targets integrins, and risankizumab, which targets the p19 subunit of IL-23. While the context does not mention FDA-approved antifungal treatments specifically targeting Malassezia spp. for Crohn's Disease, these biologic agents represent the primary FDA-approved therapies aimed at modulating the immune response in Crohn's Disease.

What other types of research exist?

Promising, novel alternatives to Posaconazole for Crohn's Disease patients include biologic agents such as ustekinumab, vedolizumab, and risankizumab. These treatments target different pathways in the immune response and have shown efficacy in managing CD, particularly in patients who have not responded to initial therapies or have developed resistance.

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Antifungal

Posaconazole for Crohn's Disease

Q: What is the mechanism of action of this treatment?

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.

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

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

0 / 8Eligibility criteria met

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.