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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Chronic rhinosinusitis (CRS) is a condition of persistent sinonasal mucosal inflammation which affects 11.9% of the US population. Mepolizumab is newly approved to treat chronic rhinosinusitis with nasal polyps (CRSwNP, the spaces inside nose and head are swollen and inflamed) and acts booking interleukin-5 (IL-5) a protein implicated in the inflammatory process. We aim to use Single-cell RNA sequencing (RNA-Seq, a method of genetically 'barcoding' cells to allow gene expression to be profiled at the level of individual cells) to study the effects of IL-5 blockade on the generation and maintenance of nasal adaptive immune responses, in CRS subjects.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+