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Monoclonal Antibodies
Dupilumab for Nasal Polyps
Phase 4
Recruiting
Led By Leigh J Sowerby, MD, FRCS
Research Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients older than 18 years old
Chronic rhinosinusitis with Nasal Polyps
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks and 24 weeks.
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test a new medication for chronic sinusitis with nasal polyps. It will follow patients for 6 months to see if the medication improves their sense of smell.
Who is the study for?
Adults over 18 with chronic rhinosinusitis and nasal polyps, who need treatment with Dupilumab and have experienced a loss of smell. Not for those whose smell loss is due to causes like cancer, injury, unknown reasons, cocaine use, or COVID-19 related issues. Pregnant individuals are also excluded.
What is being tested?
The trial tests how well Dupilumab improves the sense of smell (measured by TDI score) in patients with nasal polyps and sinusitis. It involves three clinic visits over six months to assess changes in smell function as well as other symptoms and quality of life.
What are the potential side effects?
Dupilumab may cause side effects such as injection site reactions (redness or swelling), eye problems (dryness or irritation), headaches, joint pain, and allergic reactions that can vary from mild to severe.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I have long-term sinusitis with nasal polyps.
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I have lost my sense of smell.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks and 24 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks and 24 weeks.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24.
Secondary study objectives
Change from Baseline in the Nasal Polyps score at weeks 12 and 24.
Change from Baseline in the QOD-NS at weeks 12 and 24.
Change from Baseline in the Sino-nasal outcome test- 22 (SNOT-22) at weeks 12 and 24.
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dupilumab groupExperimental Treatment1 Intervention
Patients with CRSwNP will have an initial dose of 600 mg of dupilumab, and 5 additional doses of 300mg every 4 weeks for 6 months.
Find a Location
Who is running the clinical trial?
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor
670 Previous Clinical Trials
418,328 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
683 Previous Clinical Trials
431,393 Total Patients Enrolled
Mount Sinai Hospital, CanadaOTHER
204 Previous Clinical Trials
69,170 Total Patients Enrolled
Leigh J Sowerby, MD, FRCSPrincipal InvestigatorSt. Joseph's Hospital London, ON, Canada