← Back to Search

Monoclonal Antibodies

Mepolizumab for Chronic Rhinosinusitis (ISS-RESMEPO Trial)

Phase 4

Recruiting

Led By Martin Yvon 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

At least one NP surgery* within the last 10 years

Severe NP symptoms consistent with a need for surgery (obstruction VAS symptom score>5, overall, VAS symptom score >7, endoscopic bilateral NP score ≥4 [with a score ≥2 in each nasal cavity])

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

ISS-RESMEPO Trial Summary

This trial is proposing to assess the mechanism of mepolizumab's long-lasting response to CRSwNP and identify predictors of response.

Who is the study for?

This trial is for people with severe nasal polyps and chronic rhinosinusitis who've had at least one related surgery in the last 10 years. They must have ongoing symptoms despite using nasal steroid treatments for over 4 weeks. Excluded are those with recent nose surgeries, certain allergies, HIV, or reactions to similar drugs; also excluded are pregnant women not using effective contraception.Check my eligibility

What is being tested?

The study tests Mepolizumab's long-term effects on patients with chronic rhinosinusitis and nasal polyps. It explores how this drug might lead to lasting improvements even after treatment ends by affecting various biological processes beyond just reducing inflammation caused by eosinophils.See study design

What are the potential side effects?

While specific side effects aren't listed here, Mepolizumab can generally cause headaches, injection site reactions, fatigue, and sometimes allergic reactions since it's a monoclonal antibody targeting part of the immune system.

ISS-RESMEPO Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have had nasal polyp surgery in the last 10 years.

Select...

I have severe nasal problems that require surgery.

Select...

I have been using a nasal steroid spray or wash for at least 4 weeks.

ISS-RESMEPO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Persistent clinical response to mepolizumab after cessation off mepoluzimab treatment

Other outcome measures

Determine effect of mepolizumab on trafficking of individual immune and structural cell types present in the epithelium in CRSwNP

Effect on epithelial function in vitro

Effect on epithelial function in vivo

+2 more

ISS-RESMEPO Trial Design

1Treatment groups

Experimental Treatment

Group I: Mepolizumab 100mg injectionExperimental Treatment1 Intervention

Mepolizumab 100mg SC once every 4 weeks for 48 weeks (twelve injections)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,601 Total Patients Enrolled

Martin Yvon Desrosiers, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)

1 Previous Clinical Trials

36 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Mepolizumab 100mg injection met the regulatory standards of approval?

"Mepolizumab 100mg injection has previously been approved, therefore Power rated its safety a 3 on the 1-3 scale."

Answered by AI

Are new participants being enlisted for this experiment?

"Affirmative. Records available on clinicaltrials.gov demonstrate that this research is actively enrolling participants; the trial was originally posted on October 3rd 2023 and has been amended most recently on October 13th 2023. It seeks 36 volunteers from 1 medical setting."

Answered by AI

What is the total capacity of participants for this trial?

"Affirmative. Per the information found on clinicaltrials.gov, this study is actively recruiting participants and was recently updated on October 13th 2023. The trial requires 36 individuals to be enrolled at 1 site of operation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Identifying Predictors Of Response To Mepolizumab In CRSwNP

2023. "Identifying Predictors Of Response To Mepolizumab In CRSwNP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05902325.