What side effects are associated with this type of intervention?

Common treatments for chronic sinusitis, particularly those similar to Dupilumab (which inhibits IL-4 and IL-13 signaling), include biologic agents and systemic therapies. Known side effects of these treatments can include injection site reactions, upper respiratory infections, nasopharyngitis, headache, and conjunctivitis. Additionally, systemic therapies may lead to more severe adverse effects such as increased risk of infections and potential impacts on liver and kidney function, necessitating close clinical and laboratory monitoring.

What prior FDA approvals exist?

Dupilumab, which inhibits IL-4 and IL-13 signaling, is being studied for its efficacy in treating chronic rhinosinusitis without nasal polyps. While specific FDA approvals for chronic sinusitis treatments similar to Dupilumab are not detailed, other biologic agents targeting similar pathways, such as IL-5 inhibitors (e.g., mepolizumab) and IL-13 inhibitors (e.g., lebrikizumab), have been explored for related inflammatory conditions. These agents work by modulating the immune response, which is a common therapeutic strategy for chronic inflammatory diseases.

What other types of research exist?

Promising novel alternatives to Dupilumab for Chronic Sinusitis patients include lebrikizumab, which targets IL-13, and fezakinumab, an IL-22 antagonist. Both have shown efficacy in related inflammatory conditions and may offer new therapeutic options for chronic sinusitis.

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Monoclonal Antibodies

Dupilumab for Chronic Sinusitis

Phase 2

Recruiting

Led By Jody Tversky

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Age 18-75 with history of chronic sinusitis without polyps

Be older than 18 years old

Must not have

Use of any biologic medication within the last 5 months or 5 half-lives whichever is longer

History of cancer not in remission at least 5 years prior to the date informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up continuous during entire length of study which is three years.

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial aims to test the effectiveness of dupilumab, a medication that targets specific immune responses, in treating chronic sinus disease without nasal polyps. The study focuses on patients who have limited treatment options and suffer from long-term sinus issues. Dupilumab works by blocking proteins that cause inflammation, potentially offering a new solution for these patients. Dupilumab is a novel monoclonal antibody that recently received approval for the treatment of chronic rhinosinusitis with nasal polyps.

Who is the study for?

This trial is for adults aged 18-75 with chronic sinusitis without nasal polyps, a certain level of sinus infection severity, and specific blood or allergy test results. Participants must agree to use effective contraception if applicable and can't be on certain medications or have conditions like uncontrolled asthma, immune deficiencies, recent biologic medication use, or serious illnesses.

What is being tested?

The study tests the effectiveness of Dupilumab in treating chronic rhinosinusitis without nasal polyps compared to a placebo. It aims to understand how well Dupilumab works for different underlying causes of this condition by also looking at secondary outcomes.

What are the potential side effects?

Dupilumab may cause side effects such as allergic reactions at the injection site, eye inflammation or irritation, joint pain, and possibly an increased risk of infections. 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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I am between 18 and 75 years old and have chronic sinusitis without polyps.

Exclusion Criteria

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

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I haven't taken any biologic medication in the past 5 months or longer.

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My previous cancer has been in remission for at least 5 years.

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I currently have a fungal infection in my sinuses.

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I have had hepatitis B or C in the past.

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I have not been on immunosuppression, except for oral steroids, in the last 3 months.

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I am scheduled for sinus surgery.

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I have major issues with the structure of my nose.

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I have been diagnosed with primary ciliary dyskinesia.

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I have not been treated for worm infections in the last 6 months.

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I have a known immunodeficiency disorder, including HIV.

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I am not taking any immunosuppressive medications like methotrexate or cyclosporine.

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I currently have a sinus infection.

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My asthma is not well-managed.

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I have cystic fibrosis.

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I currently have a fever of 100.4°F or higher.

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I do not have serious heart or lung conditions that are not being treated.

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I take more than 81mg of aspirin daily.

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I have had nasal polyps in the last 3 years or they were seen in a recent CT scan or endoscopy.

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I haven't taken any anti-interleukin therapy in the last 5 months or longer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ continuous during entire length of study which is three years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~continuous during entire length of study which is three years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and continuous during entire length of study which is three years. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

SNOT-22

Secondary study objectives

Adverse event rate

CT Score

Drop out rate rate

+4 more

Side effects data

From 2023 Phase 4 trial • 40 Patients • NCT04203797

Asthma

Rhinitis

Injection site erythema

Immunisation reaction

Cough

Sinus pain

100%

80%

60%

40%

20%

Study treatment Arm

Dupilumab 300 mg Q2W

Placebo

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: dupilumab treatment groupExperimental Treatment1 Intervention

dupilumab treatment group

Group II: placebo groupPlacebo Group1 Intervention

placebo group

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dupilumab

FDA approved

0 / 20Eligibility 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 Chronic Sinusitis, such as Dupilumab, work by targeting specific pathways in the immune system to reduce inflammation. Dupilumab inhibits the signaling of interleukins IL-4 and IL-13, which are crucial in the inflammatory process associated with Chronic Sinusitis. By blocking these cytokines, Dupilumab helps to decrease the inflammation and swelling in the nasal passages, leading to improved sinus drainage and reduced symptoms. This mechanism is particularly important for Chronic Sinusitis patients as it addresses the underlying inflammation rather than just alleviating symptoms, potentially leading to more effective and long-term relief.