Mepolizumab for Chronic Sinusitis with Nasal Polyps

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: St. Paul's Sinus Centre

Disqualifiers: Tumours, Immunodeficiency, Autoimmune, Smoking, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study aims to analyze the immune profiles of patients with Chronic Rhinosinusitis with Nasal polyps (CRSwNP) with and without asthma before and after Mepolizumab. A group of participants with CRS without nasal polyps (CRSsNP) with asthma will be included to compare their immune profiles to CRSwNP.

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 data supports the effectiveness of the drug mepolizumab for chronic sinusitis with nasal polyps?

Research shows that mepolizumab can reduce the size of nasal polyps and improve symptoms like nasal blockage in people with chronic sinusitis with nasal polyps. It also helps decrease the need for corticosteroids and sinus surgeries, leading to a better quality of life.

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Is Mepolizumab safe for humans?

Mepolizumab has been shown to be safe in studies for chronic rhinosinusitis with nasal polyps and other inflammatory airway diseases, with no major safety concerns reported.

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How is the drug mepolizumab unique for treating chronic sinusitis with nasal polyps?

Mepolizumab is unique because it targets and reduces blood eosinophils (a type of white blood cell involved in inflammation), which helps decrease nasal polyp size and nasal obstruction, reducing the need for sinus surgery and systemic corticosteroids, which can have adverse effects.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

St. Pual's Sinus Centre Vancouver, Canada

Who Is Running the Clinical Trial?

St. Paul's Sinus Centre Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Mepolizumab for chronic rhinosinusitis with nasal polyps: Treatment efficacy by comorbidity and blood eosinophil count. [2022] In the phase III SYNAPSE study, mepolizumab reduced nasal polyp (NP) size and nasal obstruction in chronic rhinosinusitis with NP.

2. Switzerland pubmed.ncbi.nlm.nih.gov

Real-Life Effectiveness of Mepolizumab in Refractory Chronic Rhinosinusitis with Nasal Polyps. [2023] The aim of this study was to evaluate the efficacy of mepolizumab in patients affected by chronic rhinosinusitis with nasal polyps (CRSwNP) in real-life. A single-center retrospective observational study was conducted on severe CRSwNP patients treated with mepolizumab. Nasal endoscopic polyp score (NPS), visual analogue scale (VAS) symptom score, sinonasal outcome test (SNOT-22), asthma control test (ACT) score, fractional exhaled nitric oxide (FeNO), eosinophils blood cells and prednisone intake were assessed at baseline and after 6 months. A total of 55 patients were included; 49 patients (89%) presented with asthma; aspirin exacerbated respiratory disease (AERD) in 28 patients (51%). A statistically significant decrease in the SNOT-22 score was observed (median difference -63; 95% CI: -68; -58; p < 0.001) with median t0 76 and IQR (61;90) to t6 10 (5;15). A reduction in NPS, median t0 NPS 4; (IQR:4;6), median t6 NPS 1; (IQR:0;1) p < 0.001, was greater in patients with AERD. The median baseline VAS score was 6 (IQR:6;7) and the differences between t0 and t6 were statistically significant p < 0.001. Significant changes in blood eosinophils cells, median t0 500 cell/mcl (IQR:340;830), median t6 97 cell/mcl (IQR:60;160) p < 0.001, were greater in patients with AERD. Mepolizumab treatment effects have been demonstrated with significantly reduced symptoms, polyp scores, blood eosinophils and systemic corticosteroid use, resulting in an increased health-related quality of life in patients with severe CRSwNP, regardless of the presence or absence of asthma or AERD.

3. England pubmed.ncbi.nlm.nih.gov

Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. [2022] Chronic rhinosinusitis with nasal polyps affects approximately 2-4% of the general population, and long-term use of systemic corticosteroids is associated with adverse effects. The aim of this study was to assess the efficacy and safety of mepolizumab in adults with recurrent, refractory severe bilateral chronic rhinosinusitis with nasal polyps.

4. United States 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. [2023] In the 52-week Phase III SYNAPSE study, mepolizumab given every 4 weeks (100 mg subcutaneously) reduced nasal polyp (NP) size, improved symptoms and quality of life (QoL), and reduced corticosteroid use and number of sinus surgeries in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP), versus placebo. Because the durability of mepolizumab's efficacy after discontinuation is poorly understood in CRSwNP, the efficacy of mepolizumab after discontinuation was analyzed in severe CRSwNP, over a 24-week follow-up.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluating treatment response to mepolizumab in patients with severe CRSwNP. [2023] The SYNAPSE study (NCT03085797) demonstrated that mepolizumab decreased nasal polyp (NP) size and nasal obstruction in patients with chronic rhinosinusitis with NP (CRSwNP).

6. England pubmed.ncbi.nlm.nih.gov

Mepolizumab decreases tissue eosinophils while increasing type-2 cytokines in eosinophilic chronic rhinosinusitis. [2023] Eosinophilic chronic rhinosinusitis is an often treatment-resistant inflammatory disease mediated by type-2 cytokines, including interleukin (IL)-5. Mepolizumab, a monoclonal antibody drug targeting IL-5, has demonstrated efficacy and safety in inflammatory airway disease, but there is negligible evidence on direct tissue response. The study's aim was to determine the local effect of mepolizumab on inflammatory biomarkers in sinonasal tissue of eosinophilic chronic rhinosinusitis patients.

7. Denmark pubmed.ncbi.nlm.nih.gov

Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): In-depth sinus surgery analysis. [2023] Patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) often require repeat sinus surgery. Mepolizumab reduced the need for sinus surgery in the SYNAPSE trial; this analysis sought to provide a more in-depth assessment of surgery endpoints in SYNAPSE.