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Monoclonal Antibodies

Mepolizumab for Chronic Rhinosinusitis with Nasal Polyps

Phase 4
Waitlist Available
Research Sponsored by St. Paul's Sinus Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be >=19 of age at the time of signing the informed consent form
Asthma diagnosis based on consistent clinical symptoms (History of wheeze, cough and breathlessness) and reversible airflow obstruction (Spirometry)
Must not have
Diagnosed or suspected malignant or premalignant nasal disease (e.g: Schniderian Papilloma, unilateral nasal polyposis)
Fungal rhinosinusitis (CT/Histology), positive Aspergillus skin prick testing and/or positive Aspergillus IgE RAST testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 30
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

Summary

This trial aims to study how a new drug, mepolizumab, affects inflammation in the nose and head in people with chronic rhinosinusitis.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Mepolizumab may cause side effects such as headache, injection site reactions (pain, redness), fatigue, back pain and allergic reactions including anaphylaxis. The severity of these side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 19 years old or older.
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I have asthma diagnosed with symptoms like wheezing and confirmed by a breathing test.
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I have never had sinus or lower airway disease.
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I am 19 years or older and can sign a consent form.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or might have a serious nasal condition, like a tumor or severe polyps.
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I have been diagnosed with fungal sinusitis and tested positive for Aspergillus.
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I am managing an infection that is not related to CRS.
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I am currently being treated for a long-term infection.
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I have received treatments that modify my immune system.
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I have an infection that is not due to long-term sinus issues.
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I have tumors in my nasal cavity.
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I have had a major organ or bone marrow transplant.
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I have received monoclonal antibody therapy before.
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I have had surgery for sinus issues or to remove nasal polyps.
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I am not pregnant, planning to become pregnant, or breastfeeding during the trial.
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I have EGPA with positive MPO ANCA or more than 10% eosinophils in my blood.
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I was hospitalized for an infection treated with IV or IM antibiotics within the last 60 days.
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I do not have severe heart failure or uncontrolled heart disease.
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I have a genetic condition affecting my breathing or sinuses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Endotyping nasal response to Mepolizumab
Nasal immune endotyping

Side effects data

From 2016 Phase 3 trial • 136 Patients • NCT02020889
32%
Headache
22%
Arthralgia
21%
Sinusitis
21%
Upper respiratory tract infection
18%
Nasopharyngitis
18%
Diarrhoea
16%
Vomiting
16%
Nausea
15%
Asthma
15%
Fatigue
13%
Rash
13%
Injection site reaction
12%
Back pain
12%
Neck pain
12%
Oropharyngeal pain
10%
Influenza
10%
Bronchitis
10%
Pyrexia
9%
Myalgia
9%
Musculoskeletal pain
9%
Productive cough
9%
Acute sinusitis
9%
Sinus congestion
9%
Pruritus
7%
Respiratory tract infection
7%
Vertigo
7%
Wheezing
7%
Gastroenteritis
7%
Pain in extremity
7%
Asthenia
7%
Cough
7%
Abdominal pain upper
7%
Alanine aminotransferase increased
7%
Urinary tract infection
7%
Rhinitis
6%
Fungal skin infection
6%
Oral herpes
6%
Paraesthesia
6%
Conjunctivitis
6%
Nasal congestion
6%
Urticaria
6%
Vision blurred
6%
Weight increased
6%
Ligament sprain
4%
Epistaxis
4%
Gamma-glutamyltransferase increased
4%
Oedema peripheral
4%
Sneezing
4%
Cataract
4%
Viral infection
4%
Laceration
4%
Influenza like illness
4%
Dizziness
4%
Migraine
4%
Skin lesion
4%
Eye pruritus
4%
Aspartate aminotransferase increased
4%
Muscle spasms
4%
Contusion
4%
Otitis media
4%
Adrenal insufficiency
4%
Hot flush
3%
Upper-airway cough syndrome
3%
Joint swelling
3%
Abdominal pain
3%
Sinus headache
3%
Insomnia
3%
Injection site pain
1%
Cardiac arrest
1%
Nystagmus
1%
Gastrooesophageal reflux disease
1%
Enterococcal infection
1%
Ear infection
1%
Chest pain
1%
Lacunar infarction
1%
Cerebellar ischaemia
1%
Dyspnoea
1%
Ear discomfort
1%
Hernia
1%
Pachymeningitis
1%
Perirectal abscess
1%
Facial paresis
1%
Hypersensitivity
1%
Dyspepsia
1%
Parainfluenzae virus infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mepolizumab 300mg
Placebo

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
20 subjects with CRSwNP and asthma that will start Mepolizumab treatment
Group II: Disease control groupActive Control1 Intervention
10 subjects with CRSsNP without asthma that will not start Mepolizumab and will continue their standard of care treatment.
Group III: Control groupActive Control1 Intervention
10 healthy subjects without any sinuses disease
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mepolizumab
2020
Completed Phase 4
~5010

Find a Location

Who is running the clinical trial?

St. Paul's Sinus CentreLead Sponsor
3 Previous Clinical Trials
130 Total Patients Enrolled
~6 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
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