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Monoclonal Antibodies

Dupilumab for Nasal Polyps

Phase 4

Recruiting

Led By Leigh J Sowerby, MD, FRCS

Research Sponsored by Lawson Health Research Institute

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

Study 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.Check my eligibility

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.See study design

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 below

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I am older than 18 years.

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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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks and 24 weeks. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24.

Secondary outcome measures

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.

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

659 Previous Clinical Trials

413,705 Total Patients Enrolled

Mount Sinai Hospital, CanadaOTHER

196 Previous Clinical Trials

67,581 Total Patients Enrolled

Leigh J Sowerby, MD, FRCSPrincipal InvestigatorSt. Joseph's Hospital London, ON, Canada

Frequently Asked Questions

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

Is this clinical research still taking partakers?

"Clinicaltrials.gov confirms that recruitment for this trial is still ongoing, with the original posting occurring on July 19th 2021 and a recent edit taking place on August 21st 2022."

Answered by AI

Is the FDA empowering Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] for therapeutic use?

"Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] was assigned a score of 3 because it is in its final phase clinical trial, indicating that the drug has been approved for public use."

Answered by AI

How is DUPIXENT typically utilized in medical treatment?

"DUPIXENT, a 300 MG/2 ML Subcutaneous Solution, is mostly administered for the management of dermatitis and atopic. Moreover, it can prove beneficial in treating multiple other ailments such as eosinophil failure with corticosteroid therapy or asthma."

Answered by AI

Is there prior evidence of DUPIXENT's efficacy in similar clinical trials?

"Currently, 49 clinical experiments utilising Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] are active across the globe. Of these studies, 13 have entered Phase 3 and most of them originate in Palo Alto, California; however there are 2,603 sites running trials for this medication."

Answered by AI

How many individuals are being recruited for participation in this research project?

"Affirmative. The clinicaltrials.gov website confirms that the trial, initially posted on July 19th 2021 is actively recruiting potential participants and updated most recently on August 21st 2022. Twenty-seven patients are being sought from a single centre for enrolment in this study."

Answered by AI

Has a similar research project been carried out before this one?

"First researched in 2015 and sponsored by Sanofi, Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] has been subject to numerous trials since its initial completion. Following the first study involving 880 participants, Phase 3 drug approval was granted. Presently there are 49 ongoing investigations into this medication being conducted across 436 urban centres and 43 nations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

Leigh Sowerby 2021. "Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04869436.