Dupilumab for Nasal Polyps

Overseen By Cristian Dihel, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Must be taking: Dupilumab

Disqualifiers: Sinonasal malignancies, Trauma, Cocaine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

27 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests dupilumab (also known as Dupixent) for treating chronic rhinosinusitis with nasal polyps, a condition that causes nasal congestion and can reduce the sense of smell. The main goal is to assess how dupilumab affects the ability to smell using a test called the Sniffin' Sticks. Researchers will also evaluate other factors, such as nasal polyp size and the impact on daily life. Individuals who have lost their sense of smell due to chronic rhinosinusitis with nasal polyps and are candidates for dupilumab treatment might be suitable for this trial. Participants will receive dupilumab over six months and visit the clinic three times. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for dupilumab?

Research has shown that dupilumab is generally safe for treating chronic rhinosinusitis with nasal polyps (CRSwNP). In studies, most patients have tolerated dupilumab well. Common side effects include injection site reactions, eye issues, and throat pain, which are usually mild to moderate.

The FDA has already approved dupilumab for CRSwNP, supporting its safety for this condition. For questions or concerns about joining a clinical trial, discussing them with a doctor is advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dupilumab is unique because it targets interleukin-4 and interleukin-13 signaling pathways, which play a key role in the inflammation associated with nasal polyps. Unlike traditional treatments like corticosteroids or surgery, which mainly focus on reducing symptoms or removing polyps, dupilumab addresses the underlying immune response. Researchers are excited about this treatment because it offers a more targeted approach, potentially providing longer-lasting relief and reducing the need for surgery or repeated steroid use.

What is the effectiveness track record for dupilumab in treating nasal polyps?

Research has shown that dupilumab, the treatment under study in this trial, effectively treats chronic rhinosinusitis with nasal polyps (CRSwNP). In one study, participants experienced a 54% improvement in nasal congestion after 52 weeks of treatment. Another study found that the average score measuring symptoms and their impact, known as SNOT-22, dropped by 37.2 points after using dupilumab. Additionally, dupilumab significantly reduced the size of nasal polyps. Overall, these findings indicate that dupilumab can effectively improve symptoms in people with CRSwNP. ^{4 6 7 8 9}

Who Is on the Research Team?

Leigh Sowerby, MD

Principal Investigator

St. Joseph's Hospital London, ON, Canada

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am older than 18 years.

My doctor recommends Dupilumab for my condition.

I have long-term sinusitis with nasal polyps.

Exclusion Criteria

I have lost my sense of smell due to reasons like injury, drug use, or COVID-19.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dupilumab treatment with an initial dose of 600 mg, followed by 5 additional doses of 300 mg every 4 weeks for 6 months

6 months

3 visits (in-person) at Baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on changes in TDI score, Nasal Polyps score, SNOT-22, and QOD-NS

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Dupilumab group Experimental Treatment 1 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.

Dupilumab is already approved in United States, European Union for the following indications:

Approved in United States as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Mount Sinai Hospital, Canada

Collaborator

Trials

210

Recruited

70,700+

Published Research Related to This Trial

In a study of 97 patients with chronic rhinosinusitis with nasal polyps (CRSwNP), dupilumab treatment led to significant reductions in polyp size after 6 months, with median total polyp scores dropping from 3 to 0 for small polyps and from 6 to 2 for large polyps.

The effectiveness of dupilumab was consistent regardless of polyp size at the start of treatment, and the use of oral or nasal steroids did not affect the treatment's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The "real life" efficacy of dupilumab is independent of initial polyp size and concomitant steroids in CRSwNP. Campion, NJ., Brugger, J., Tu, A., et al.[2023]

Dupilumab significantly improved symptoms and objective measures of chronic rhinosinusitis with nasal polyps (CRSwNP) in patients, regardless of whether they also had allergic rhinitis, based on a pooled analysis of 724 patients from two phase III studies.

The treatment also reduced the need for systemic corticosteroids and sinonasal surgery, demonstrating its efficacy and safety profile, which was consistent across patients with and without allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab efficacy in patients with chronic rhinosinusitis with nasal polyps with and without allergic rhinitis. Peters, AT., Wagenmann, M., Bernstein, JA., et al.[2023]

In the phase 3 SINUS-24 and SINUS-52 studies involving 438 adults with severe chronic rhinosinusitis with nasal polyps, dupilumab significantly improved nasal polyp scores and nasal congestion compared to standard care, with 70% of patients showing improvement by Week 4 and 78.7% by Week 52.

Dupilumab treatment resulted in clinically meaningful improvements in nasal polyp scores for 55.7% of patients at Week 4 and 72.3% at Week 52, while only 5.7% of dupilumab patients experienced worsening symptoms at Week 52, compared to 40.1% in the standard care group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid and Continuing Improvements in Nasal Symptoms with Dupilumab in Patients with Severe CRSwNP. Bachert, C., Khan, AH., Hopkins, C., et al.[2022]

Dupilumab is a monoclonal antibody that effectively targets the IL-4 receptor, significantly improving symptoms and quality of life in adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) over 24 to 52 weeks in phase III studies.

The treatment was well tolerated and led to reductions in nasal polyp size, sinus opacification, and the need for systemic corticosteroids or nasal polyp surgery, showing benefits even in patients with comorbid asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab: A Review in Chronic Rhinosinusitis with Nasal Polyps. Hoy, SM.[2022]

In a study of 130 patients treated with dupilumab for severe chronic rhinosinusitis with nasal polyps over 18 months, there was a significant reduction in nasal polyposis and improvement in symptoms and quality of life.

The treatment was associated with a transient increase in blood eosinophils and a gradual decrease in total IgE levels, indicating potential changes in immune response, although IgG and IgA levels remained within normal ranges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab's Impact on Blood Parameters in Nasal Polyposis: 18-Month Follow-Up in Real Life. Loperfido, A., Ciofalo, A., Cavaliere, C., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02912468

NCT02912468 | A Controlled Clinical Study of Dupilumab ... Primary Objective: To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to placebo on a background of mometasone furoate ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11799128/

Effect of Dupilumab in CRSwNP Sinonasal Outcomes from ... Significant improvements were noted, with the average SNOT-22 score reduction being 37.2 points post-dupilumab treatment. The nasal polyp size ( ...

3. dupixenthcp.com dupixenthcp.com/crswnp/efficacy/nasal-polyp-and-congestion-score

nasal congestion and polyp score data in adults DUPIXENT (dupilumab) clinical trials showed a 54% improvement in nasal congestion score at week 52 in chronic rhinosinusitis with nasal polyposis patients.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04959448

NCT04959448 | Study Assessing Long-teRm Outcomes of ... Study assessing long-term outcomes of dupilumab (DUPIXENT®) treatment in adult patients with chronic rhinosinusitis with nasal polyposis (CRSwNP)

5. sciencedirect.com sciencedirect.com/science/article/pii/S2213219824009413

Dupilumab Versus Mepolizumab for Chronic Rhinosinusitis ... Dupilumab and mepolizumab have shown efficacy and safety in treating chronic rhinosinusitis with nasal polyps (CRSwNP).

6. dupixenthcp.com dupixenthcp.com/crswnp/efficacy/safety-data-and-design

safety data and study designs in adults Review DUPIXENT® (dupilumab) demonstrated safety profile and clinical trial information for inadequately controlled chronic rhinosinusitis with nasal polyps ...

7. dupixent.com dupixent.com/crswnp/

DUPIXENT® (dupilumab) in Adults with Nasal Polyps Important Safety Information and Indication · have eye problems. · have a parasitic (helminth) infection. · are scheduled to receive any vaccinations. You should ...

8. regeneron.com regeneron.com/downloads/dupixent_fpi.pdf

DUPIXENT® Full Prescribing Information Chronic Rhinosinusitis with Nasal Polyps (2.5):. Recommended dosage for adult and pediatric patients 12 years of age and older is 300 mg given every 2 weeks ( ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10141684/

Effectiveness and Safety Profile of Dupilumab in Chronic ... Dupilumab radically changes the treatment of CRSwNP, but, considering its recent approval, it may be useful to evaluate its safety profile in a real-world ...