What side effects are associated with this type of intervention?

Common treatments for Chronic Rhinosinusitis (CRS) include corticosteroids, antibiotics, and biologics like Dupilumab. Dupilumab, which inhibits IL-4 and IL-13 signaling to reduce Type 2 inflammation, has been associated with side effects such as injection site reactions, conjunctivitis, and eosinophilia. Other biologics used for CRS, such as Omalizumab and Mepolizumab, can cause side effects including headache, injection site reactions, and potential allergic reactions. Corticosteroids, often used in CRS management, may lead to side effects like nasal irritation, nosebleeds, and, with long-term use, systemic effects such as adrenal suppression and osteoporosis.

What prior FDA approvals exist?

Dupilumab, which inhibits IL-4 and IL-13 signaling to reduce Type 2 inflammation, has been approved by the FDA for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Other biologics targeting Type 2 inflammation, such as Omalizumab (an anti-IgE antibody), have also been explored for similar conditions, although their primary indications are for asthma and other allergic conditions. These treatments aim to modulate the immune response to reduce inflammation and improve symptoms in patients with chronic inflammatory diseases.

What other types of research exist?

Promising novel alternatives to Dupilumab for Chronic Rhinosinusitis patients include: 1. Lebrikizumab (targets IL-13) 2. Fezakinumab (targets IL-22) 3. Risankizumab (targets IL-23) 4. Benralizumab (targets IL-5 receptor) These alternatives target different cytokines involved in Type 2 inflammation and have shown efficacy in related inflammatory conditions.

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Monoclonal Antibodies

Dupilumab for Chronic Rhinosinusitis with Nasal Polyps

Phase 4

Waitlist Available

Led By Martin Y Desrosiers, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

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

Must have

Patients ≥ 18 years of age

Be older than 18 years old

Must not have

Local complications such as radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis, mucoceles, patients with nasal cavity malignant tumor and benign tumors, patients receiving concomitant treatment prohibited in the study

Patients with the following liver injury related criteria at V1: clinically significant/active underlying hepatobiliary disease, alanine aminotransferase (ALT) >3 upper limit of normal (ULN)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week -4 (4 weeks prior to surgery) to week 16

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing Dupilumab, an anti-inflammatory medication, on patients with chronic sinus issues and nasal polyps who are undergoing multiple surgeries. The goal is to see if it can help reduce inflammation and improve healing after surgery. Dupilumab is a novel monoclonal antibody that recently received US Food and Drug Administration approval for the treatment of chronic rhinosinusitis with nasal polyps.

Who is the study for?

Adults over 18 with chronic rhinosinusitis and nasal polyps scheduled for revision surgery, experiencing ongoing symptoms. Excluded are those with recent sinus surgeries, certain infections or conditions that could affect the study's outcome, a history of significant illness, immunosuppression, malignancy within 5 years (with exceptions), pregnant or breastfeeding women, and those not using acceptable contraception.

What is being tested?

The trial is testing if Dupilumab injections before and after sinus surgery can prevent recurrence of nasal polyps by reducing Type 2 inflammation. Participants will receive either Dupilumab or placebo in seven injections around the time of their surgery. The main goal is to see if there's less swelling in the sinuses afterwards.

What are the potential side effects?

Dupilumab may cause side effects like allergic reactions at injection sites, eye problems (like redness or itching), headaches, joint pain, and possibly more serious allergic reactions. Mometasone Furoate might cause nosebleeds, sore throat or coughing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

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

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I have complications in my nose or sinuses, possibly due to a tumor or fungal infection.

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My liver is generally healthy and my ALT levels are not more than three times the normal limit.

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I have a condition like cystic fibrosis or similar.

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

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I have HIV or tested positive for HIV.

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I have active or untreated tuberculosis, or a history of incomplete TB treatment.

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I have an active autoimmune disease or am on immunosuppressive therapy.

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I have active hepatitis.

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I do not have any conditions that the medication's label warns against.

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I've had nose surgery that altered its structure, affecting nasal symptom evaluation.

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I do not have major nasal issues like severe polyps, deviated septum blocking a nostril, or ongoing infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week -4 (4 weeks prior to surgery) to week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week -4 (4 weeks prior to surgery) to week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week -4 (4 weeks prior to surgery) to week 16 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Edema

Secondary study objectives

Nose

Change in Computerized tomography (CT) Scan opacification

Change in asthma control

+10 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DupilumabExperimental Treatment2 Interventions

Sterile Dupilumab 150 mg/mL will be provided in pre-filled syringes (2.25 total volume) to deliver 300 mg in 2 mL.

Group II: PlaceboPlacebo Group2 Interventions

Sterile placebo for Dupilumab will be provided in identically matching pre-filled syringes to deliver 2 mL.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mometasone Furoate nasal spray

2007

Completed Phase 3

~140

0 / 12Eligibility 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) often target the underlying inflammation that characterizes the condition. Dupilumab, for example, inhibits IL-4 and IL-13 signaling, which are key drivers of Type 2 inflammation. By reducing this type of inflammation, Dupilumab helps to decrease mucosal edema, polyp size, and sinus symptoms, leading to improved quality of life and better post-surgical outcomes. This is particularly important for CRS patients as it addresses the root cause of their symptoms, leading to more effective and sustained relief.