Mepolizumab for Chronic Sinusitis with Nasal Polyps

Overseen By Atenea Pascual, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: St. Paul's Sinus Centre

Disqualifiers: Tumours, Immunodeficiency, Autoimmune, Smoking, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 24 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Mepolizumab, an antibody therapy, for individuals with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), characterized by ongoing sinus inflammation and nasal growths. The research aims to assess Mepolizumab's effects on the immune system in patients with and without asthma. Participants with CRSwNP may qualify if they have persistent sinus issues and nasal polyps, along with doctor-confirmed asthma. The trial includes two groups: one receiving Mepolizumab and another receiving a placebo to compare results. As a Phase 4 trial, this research focuses on understanding how this already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Mepolizumab?

Research has shown that mepolizumab is safe for treating chronic rhinosinusitis with nasal polyps (CRSwNP). Studies have found that it usually causes only minor side effects. For instance, patients reported few problems when using mepolizumab for similar conditions.

The treatment received approval for CRSwNP in 2021, indicating that its safety underwent thorough evaluation. In studies comparing it to other treatments, mepolizumab proved both effective and safe.

These findings can reassure those considering participation in a trial with mepolizumab. Always consult a doctor about any concerns or questions regarding treatment options. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Mepolizumab is unique because it specifically targets and reduces levels of interleukin-5 (IL-5), a protein that plays a key role in the development of nasal polyps. Unlike standard treatments for chronic sinusitis with nasal polyps, which often involve steroids or surgery, Mepolizumab offers a targeted biological approach. This means it can potentially reduce inflammation and polyp size more effectively with fewer side effects. Researchers are excited about Mepolizumab because it represents a new way to manage this condition, potentially improving patient outcomes and quality of life.

What is the effectiveness track record for Mepolizumab in treating Chronic Sinusitis with Nasal Polyps?

Research has shown that Mepolizumab, which participants in this trial may receive, effectively treats chronic rhinosinusitis with nasal polyps (CRSwNP). Studies have found that it eases nasal symptoms and improves quality of life. Patients have reported needing fewer surgeries and using steroids less frequently. Mepolizumab also helps restore the sense of smell, with noticeable improvement at 6 and 12 months. Its proven effectiveness for other conditions increases confidence in its use for CRSwNP. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 19 with Chronic Rhinosinusitis and nasal polyps, with or without asthma. Participants must not be smokers, have a history of lung transplants, sinus or bronchial tumors, certain infections, autoimmune diseases, immunodeficiency or allergies to biologics. Women must use birth control and have negative pregnancy tests during the study.

Inclusion Criteria

I am over 19 years old.

I have chronic sinusitis with nasal polyps, with or without asthma, confirmed by tests.

I am using birth control and have a negative pregnancy test.

Exclusion Criteria

I have a parasitic worm infection.

I am not pregnant or breastfeeding.

You currently smoke or used to smoke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Eligibility confirmed and baseline measurements taken, including nasal sample collection for cytokine analysis

1 week

1 visit (in-person)

Treatment

Participants receive Mepolizumab or placebo every 4 weeks for 24 weeks, with nasal sample collection and questionnaires administered

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mepolizumab

Trial Overview

The study compares immune responses in patients treated with Mepolizumab versus those given a placebo. It includes chronic rhinosinusitis sufferers both with and without nasal polyps but excludes individuals who've recently taken antibiotics or have specific health exclusions.

How Is the Trial Designed?

Group I: Mepolizumab Experimental Treatment 1 Intervention

Mepolizumab (100 mg) subcutaneously every 4 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo 100 mg subcutaneously every 4 weeks

Who Is Running the Clinical Trial?

St. Paul's Sinus Centre

Lead Sponsor

Trials

4

Recruited

170+

Published Research Related to This Trial

In a phase 3 trial involving 414 patients with severe chronic rhinosinusitis and nasal polyps, mepolizumab significantly reduced nasal polyp size and improved nasal obstruction compared to placebo after 52 weeks of treatment.

The safety profile of mepolizumab was similar to placebo, with no new safety concerns identified, suggesting it is a safe and effective add-on therapy for patients who do not respond to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Han, JK., Bachert, C., Fokkens, W., et al.[2022]

In the SYNAPSE study involving 407 patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP), mepolizumab significantly reduced nasal polyp size and nasal obstruction compared to placebo, demonstrating its efficacy as a treatment option.

By Weeks 24 and 52, a majority of patients treated with mepolizumab who did not undergo surgery showed sustained improvement across multiple response criteria, highlighting its potential to manage symptoms effectively without the need for surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating treatment response to mepolizumab in patients with severe CRSwNP. Hopkins, C., Han, JK., Lund, VJ., et al.[2023]

In a study of 55 patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) treated with mepolizumab, significant improvements were observed in nasal symptoms and polyp scores after 6 months, particularly in patients with aspirin-exacerbated respiratory disease (AERD).

Mepolizumab treatment led to a marked reduction in blood eosinophil levels and decreased reliance on systemic corticosteroids, enhancing the overall quality of life for patients with CRSwNP, regardless of asthma status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Life Effectiveness of Mepolizumab in Refractory Chronic Rhinosinusitis with Nasal Polyps. Domínguez-Sosa, MS., Cabrera-Ramírez, MS., Marrero-Ramos, MDC., et al.[2023]

In a study involving 20 adult patients with eosinophilic chronic rhinosinusitis, treatment with mepolizumab for 24 weeks significantly reduced eosinophil counts in sinonasal tissue, indicating its efficacy in targeting IL-5 to suppress eosinophil trafficking.

Despite the reduction in eosinophils, levels of type-2 cytokines (IL-5, IL-4, IL-13, and GM-CSF) increased in the tissue, suggesting a potential local inflammatory feedback loop that may contribute to incomplete treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mepolizumab decreases tissue eosinophils while increasing type-2 cytokines in eosinophilic chronic rhinosinusitis. Walter, S., Ho, J., Alvarado, R., et al.[2023]

In the 52-week Phase III SYNAPSE study, mepolizumab significantly reduced nasal polyp size and improved symptoms in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP), showing sustained benefits even 24 weeks after treatment discontinuation.

Among 134 patients followed up, those who received mepolizumab had better outcomes, such as lower nasal polyp scores and reduced need for sinus surgery, compared to placebo, indicating that the treatment's effects can last beyond the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained efficacy of mepolizumab in patients with severe chronic rhinosinusitis with nasal polyps: SYNAPSE 24-week treatment-free follow-up. Desrosiers, M., Diamant, Z., Castelnuovo, P., et al.[2023]

In the SYNAPSE trial involving 407 adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP), mepolizumab significantly reduced the risk of patients being placed on a waiting list for sinus surgery compared to placebo, with a probability estimate of 13.9% versus 28.5% at week 52.

Mepolizumab also lowered the risk of needing sinus surgery regardless of how long it had been since the last surgery or the patients' baseline blood eosinophil counts, indicating its broad efficacy in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): In-depth sinus surgery analysis. Fokkens, WJ., Mullol, J., Kennedy, D., et al.[2023]

In the phase III SYNAPSE study involving 407 patients, mepolizumab significantly reduced nasal polyp size and nasal obstruction in chronic rhinosinusitis with nasal polyps, showing efficacy across various subgroups including those with asthma and aspirin-exacerbated respiratory disease (AERD).

Patients receiving mepolizumab demonstrated a higher rate of improvement in nasal polyp scores and nasal obstruction compared to those on placebo, indicating that mepolizumab is effective regardless of baseline blood eosinophil counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mepolizumab for chronic rhinosinusitis with nasal polyps: Treatment efficacy by comorbidity and blood eosinophil count. Bachert, C., Sousa, AR., Han, JK., et al.[2022]

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