Mepolizumab for Chronic Rhinosinusitis with Nasal Polyps

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: St. Paul's Sinus Centre

Must be taking: Mepolizumab

Must not be taking: Monoclonal antibodies

Disqualifiers: Pregnancy, Cancer, HIV, Transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 8

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Mepolizumab, a drug targeting a protein involved in inflammation, to assess its effects on individuals with chronic rhinosinusitis with nasal polyps (CRSwNP), a condition characterized by swollen and inflamed spaces inside the nose and head. Researchers aim to understand how blocking this protein might alter immune responses in the nose. The trial includes three groups: those with CRSwNP and asthma who will receive Mepolizumab, those with chronic rhinosinusitis without nasal polyps who will continue their usual care, and healthy individuals for comparison. Individuals with both CRSwNP and asthma who are awaiting surgery might be suitable for the treatment group. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on certain treatments for infections or have received monoclonal antibody therapy, you may not be eligible. It's best to discuss your specific medications with the trial team.

What is the safety track record for Mepolizumab?

Research has shown that mepolizumab is generally safe for people with chronic rhinosinusitis with nasal polyps (CRSwNP). Approved since 2021, this treatment's safety is supported by previous studies. Some individuals might experience side effects, but these are usually mild. Mepolizumab should not be used by those allergic to it or any of its ingredients. Although serious side effects can occur, they are rare. Overall, available data consider the treatment safe. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Mepolizumab is unique because it targets interleukin-5 (IL-5), a protein that plays a key role in the inflammation process, specifically reducing eosinophils, which are often elevated in conditions like chronic rhinosinusitis with nasal polyps (CRSwNP). Unlike standard treatments such as corticosteroids or surgery, which mainly address symptoms or physical blockages, mepolizumab works at the immune level to tackle the underlying cause of inflammation. This targeted approach not only offers a new avenue for managing CRSwNP but also holds promise for patients who have not found relief with traditional therapies. Researchers are excited because it could lead to better symptom control and potentially fewer side effects.

What is the effectiveness track record for Mepolizumab in treating chronic rhinosinusitis with nasal polyps?

Research has shown that mepolizumab effectively treats chronic rhinosinusitis with nasal polyps (CRSwNP). Studies have found that it significantly reduces nasal symptoms and the size of nasal polyps. In this trial, participants with CRSwNP and asthma will receive mepolizumab treatment. Specifically, patients in those studies experienced a better quality of life and needed fewer nasal surgeries. Importantly, their sense of smell improved, with noticeable gains at 6 and 12 months. These benefits make mepolizumab a promising option for managing CRSwNP. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

Adults diagnosed with chronic rhinosinusitis and nasal polyps, who have asthma symptoms and reversible airflow obstruction. They must be on a surgery waitlist for over 6 months, without other sinonasal diseases or severe allergies to monoclonal antibodies. Pregnant women, those with certain infections or immune conditions, severe heart failure, recent major organ transplants, or participation in other trials are excluded.

Inclusion Criteria

Criterion: Your nasal polyps score is between 1 and 8.

I am on a surgery waiting list for more than 6 months.

I am 19 years old or older.

Exclusion Criteria

You have severe allergies to monoclonal antibodies.

Participants currently participating in other clinical trials

I have or might have a serious nasal condition, like a tumor or severe polyps.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-treatment

Nasal and blood samples collected before Mepolizumab commencement

6 weeks

1 visit (in-person)

Treatment

Participants receive 100mg of Mepolizumab every 4 weeks subcutaneously

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 trial is testing Mepolizumab's effect on patients with chronic rhinosinusitis and nasal polyps by blocking IL-5 protein involved in inflammation. It uses advanced genetic 'barcoding' (Single-cell RNA sequencing) to study individual cells' response to treatment.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

20 subjects with CRSwNP and asthma that will start Mepolizumab treatment

Group II: Disease control group Active Control 1 Intervention

10 subjects with CRSsNP without asthma that will not start Mepolizumab and will continue their standard of care treatment.

Group III: Control group Active Control 1 Intervention

10 healthy subjects without any sinuses disease

Who Is Running the Clinical Trial?

St. Paul's Sinus Centre

Lead Sponsor

Trials

4

Recruited

170+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38696895/

Effectiveness and safety profile of mepolizumab in chronic ...

A statistically significant reduction in the Sino-Nasal Outcome Tests-22 (SNOT-22) and nasal polyp score (NPS) was shown at the 6th and 12th months compared to ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0196070924003831

Mepolizumab in chronic rhinosinusitis with nasal polyps

One of the most important data was the recovery of olfactory function, which showed +4 and +7 compared with baseline values at 6 and 12 months, respectively.

3.

jaci-global.org

jaci-global.org/article/S2772-8293(25)00150-X/fulltext

Mepolizumab for the management of chronic rhinosinusitis ...

Mepolizumab was found to improve nasal symptoms and health-related quality of life and to reduce NP size, number of nasal surgeries, and SCS receipt in patients ...

4.

jacionline.org

jacionline.org/article/S0091-6749(24)02320-0/fulltext

Mepolizumab Improves Patient-Reported Outcomes and ...

Despite established clinical trial efficacy, real-world data on mepolizumab effectiveness in chronic rhinosinusitis with nasal polyps (CRSwNP) are limited.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40978169/

Mepolizumab for the management of chronic rhinosinusitis ...

In this first retrospective mepolizumab study for patients with CRSwNP without severe asthma, improvements in all outcomes were observed ...

6.

nucalahcp.com

nucalahcp.com/nasal-polyps/

Learn About a CRSwNP Treatment Option

Find more information about NUCALA for chronic rhinosinusitis with nasal polyps (CRSwNP). Review safety data, clinical trials, patient profiles, and dosing.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0196070924001157

Effectiveness and safety profile of mepolizumab in chronic ...

Effectiveness and safety profile of mepolizumab in chronic rhinosinusitis with nasal polyps: Real life data in a tertiary care. Author links open overlay ...

8.

nucala.com

nucala.com/chronic-rhinosinusitis-nasal-polyps/

Chronic Rhinosinusitis with Nasal Polyps Treatment

Important Safety Information. Do not use NUCALA if you are allergic to mepolizumab or any of the ingredients in NUCALA. NUCALA can cause serious side effects ...