What is the mechanism of action of this treatment?

The most common treatments for Chronic Rhinosinusitis (CRS) include Dupilumab and Omalizumab, which target specific pathways involved in the inflammatory and allergic responses. Dupilumab works by inhibiting IL-4 and IL-13, cytokines that play a crucial role in the inflammatory process, thereby reducing inflammation and tissue damage. Omalizumab, on the other hand, inhibits IgE, preventing it from binding to receptors on mast cells and basophils, which reduces allergic reactions. These mechanisms are significant for CRS patients as they directly address the underlying causes of chronic inflammation and allergies, leading to symptom relief and improved quality of life.

What side effects are associated with this type of intervention?

Dupilumab, an IL-4 and IL-13 inhibitor, commonly causes side effects such as injection site reactions, conjunctivitis, and nasopharyngitis. Omalizumab, an IgE inhibitor, is associated with side effects including injection site reactions, headache, and an increased risk of infections. Both treatments are generally well-tolerated but can have serious adverse effects such as anaphylaxis, though these are rare.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Rhinosinusitis, particularly targeting inflammatory pathways. Dupilumab, an IL-4 and IL-13 inhibitor, has been approved for treating Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Omalizumab, an IgE inhibitor, is also approved for CRSwNP, providing an option for patients with severe allergic components. These biologics work by modulating the immune response, reducing inflammation, and improving symptoms in patients with chronic rhinosinusitis.

What other types of research exist?

Promising novel alternatives to Dupilumab and Omalizumab for Chronic Rhinosinusitis patients include Tezepelumab, which targets thymic stromal lymphopoietin (TSLP), and Benralizumab, which targets the IL-5 receptor. Both have shown efficacy in related inflammatory conditions and may offer new therapeutic options for CRS.

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Monoclonal Antibodies

Dupilumab vs Omalizumab for Nasal Polyps (EVEREST Trial)

Phase 4

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eligibility as per omalizumab drug-dosing table (serum IgE level ≥30 to ≤1500 IU/mL and body weight ≥30 to ≤150 kg) and ability to be dosed per the dosing table.

Participants with bilateral sino-nasal polyposis, meeting specific endoscopic and symptom criteria

Must not have

Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drugs within 2 weeks before Visit 1 (screening visit) or during the screening and run-in period.

Known or suspected immunodeficiency, including history of invasive opportunistic infections.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 36

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial compares Dupilumab and Omalizumab to see which is better at reducing nasal polyps and improving symptoms in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Both medications work by reducing inflammation but target different parts of the immune system. Omalizumab is a biologic agent that blocks the action of immunoglobulin E and has been shown to be effective in treating severe allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).

Who is the study for?

This trial is for adults with chronic rhinosinusitis and nasal polyps who've had symptoms like nasal blockage or loss of smell for at least 8 weeks, despite previous treatments. They should have used mometasone before and meet specific criteria for asthma control and body weight/IgE levels. People can't join if they've had recent sinus surgery, certain infections including HIV, severe allergies to the drugs being tested, or a history of cancer within the last 5 years.

What is being tested?

The study compares Dupilumab against Omalizumab in reducing nasal polyp size and improving sense of smell by week 24. It also looks at how these drugs affect other symptoms, lung function, quality of life, asthma control, and overall disease severity. Participants are randomly assigned to receive either drug or a placebo.

What are the potential side effects?

Potential side effects include allergic reactions to the medications such as rash or itching; possible injection site reactions like pain or swelling; headache; eye irritation; joint pain; nausea; fatigue. 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

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My IgE levels and weight match the criteria for omalizumab treatment.

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I have polyps in both sides of my nose confirmed by a special nose exam.

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I have had severe nasal congestion for over a week.

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I have been using mometasone nasal spray daily for at least a month.

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I am at least 18 years old or the legal age of consent where the study is conducted.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I might have a parasite infection or have taken antiparasitic drugs recently.

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I have a weak immune system or a history of serious infections.

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I do not have HIV or have not tested positive for HIV.

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I have not received a live vaccine in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline to Week 24 in Nasal Polyp Score (NPS)

Change from baseline to Week 24 in University of Pennsylvania Smell Identification Test (UPSIT)

Secondary study objectives

Change from baseline to Week 24 in 22-Item Sino-nasal Outcome Test (SNOT-22)

Change from baseline to Week 24 in Nasal Peak Inspiratory Flow (NPIF)

Change from baseline to Week 24 in SNOT-22 nasal domain score

+6 more

Side effects data

From 2016 Phase 4 trial • 17 Patients • NCT02023151

77%

Infections

100%

80%

60%

40%

20%

Study treatment Arm

Omalizumab

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

Group I: OmalizumabExperimental Treatment2 Interventions

Dosing Q2W or every 4 weeks (Q4W)

Group II: DupilumabExperimental Treatment2 Interventions

Dosing every 2 weeks (Q2W)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dupilumab

2017

Completed Phase 4

~11960

Omalizumab

2006

Completed Phase 4

~2350

Placebo

1995

Completed Phase 3

~2670

0 / 9Eligibility 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

The most common treatments for Chronic Rhinosinusitis (CRS) include Dupilumab and Omalizumab, which target specific pathways involved in the inflammatory and allergic responses. Dupilumab works by inhibiting IL-4 and IL-13, cytokines that play a crucial role in the inflammatory process, thereby reducing inflammation and tissue damage. Omalizumab, on the other hand, inhibits IgE, preventing it from binding to receptors on mast cells and basophils, which reduces allergic reactions. These mechanisms are significant for CRS patients as they directly address the underlying causes of chronic inflammation and allergies, leading to symptom relief and improved quality of life.