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Monoclonal Antibodies

Mepolizumab for Chronic Sinusitis with Nasal Polyps

Phase 4
Recruiting
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
Are over the age of 19
Females of childbearing potential must commit to using an acceptable method of birth control for the duration of the study and they must have a negative urine pregnancy test at each study visit
Must not have
Subjects with parasitic (helmintic) infection
Female participants who are pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will compare immune profiles of people with CRSwNP with/without asthma before/after treatment with Mepolizumab. Results could help tailor treatment for CRSwNP.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the trial description doesn't specify side effects of Mepolizumab, common ones may include headache, injection site reactions (pain or swelling), fatigue and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 19 years old.
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I am using birth control and have a negative pregnancy test.
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I have asthma and chronic rhinosinusitis without nasal polyps, and will only attend initial study visits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a parasitic worm infection.
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I am not pregnant or breastfeeding.
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I have had a lung transplant.
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I have or had tumors in my nose or airways.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compare the immune profile in CRSwNP patients with and without asthma (before and after Mepolizumab treatment), and with asthmatic CRSsNP patients.
Secondary study objectives
Examine the treatment response to Mepolizumab in CRSwNP patients with and without asthma.
Explore the effects of Mepolizumab compared to placebo in the treatment of Chronic Rhinosinusitis

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%
Musculoskeletal pain
9%
Productive cough
9%
Acute sinusitis
9%
Myalgia
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

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MepolizumabExperimental Treatment1 Intervention
Mepolizumab (100 mg) subcutaneously every 4 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo 100 mg subcutaneously every 4 weeks
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
80 Total Patients Enrolled
1 Trials studying Chronic Sinusitis
40 Patients Enrolled for Chronic Sinusitis
~5 spots leftby Dec 2024
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