Dupilumab for Nasal Polyps

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Madigan Army Medical Center

Must be taking: Intranasal corticosteroids

Must not be taking: Biologics

Disqualifiers: Asthma, Cystic fibrosis, Pregnancy, 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

Compensation: Varies

Number of Visits: 4

Duration: 28 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new schedule for taking Dupilumab, a medicine for individuals with stubborn nasal polyps and chronic sinus issues. Researchers aim to determine if this new schedule is as effective as the current one. Participants must have undergone sinus surgery and continue to experience sinus problems despite using nasal sprays. Those who fit this profile and seek alternative treatment options may be suitable for this study. As a Phase 4 trial, this research helps to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be using an intranasal corticosteroid spray or irrigation to participate.

What is the safety track record for Dupilumab?

Studies have shown that Dupilumab is generally safe for people with chronic rhinosinusitis with nasal polyps. Research indicates that most people experience only mild side effects, such as injection site reactions or mild cold-like symptoms. Serious side effects are rare.

The FDA has already approved Dupilumab for treating nasal polyps, confirming it meets safety standards for this condition. Real-life data and clinical trials consistently support its safety. For most patients, the benefits of the treatment outweigh the risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dupilumab is unique because it targets the IL-4 and IL-13 pathways, which are key players in the inflammatory process behind nasal polyps. Unlike conventional treatments like corticosteroids or surgery, Dupilumab offers a non-invasive alternative with the potential for long-term control. Researchers are excited because it could provide a more effective and sustainable option for patients who struggle with recurring polyps and the side effects of current treatments. Additionally, the trial is exploring two different dosing schedules to optimize its use, offering potential flexibility in treatment plans.

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

Research has shown that Dupilumab effectively treats chronic rhinosinusitis with nasal polyps. Studies have found that it significantly reduces symptoms and improves quality of life. For instance, patients reported easier breathing and less nasal blockage. Dupilumab also shrinks nasal polyps and reduces the need for surgery and steroid treatments. Real-world evidence supports these findings, demonstrating lasting improvement over time. This trial will compare two administration schedules of Dupilumab to evaluate its effectiveness further. This treatment has already proven effective for these conditions. ^{4 6 7 8 9}

Who Is on the Research Team?

Renee M Serra, MD

Principal Investigator

ENT/Audiology Department Chair

Roy F Thomas, MD

Principal Investigator

Rhinologist

Are You a Good Fit for This Trial?

This trial is for patients with chronic rhinosinusitis and nasal polyps who've had full sinus surgery and are on topical meds. It's not clear what excludes someone from participating, but typically, it would involve factors like other health issues or treatments that could interfere with the study.

Inclusion Criteria

I am currently using a nasal spray or rinse that contains steroids.

I have had sinus surgery before.

Active duty servicemembers must be in the area for at least 7 months after starting the medication to complete the necessary follow ups

Exclusion Criteria

My asthma causes my lung function to be below 50%.

Patient is a pregnant woman, may become pregnant, or breastfeeding.

I haven't used any biologic therapy in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 300 mg Subcutaneous Dupilumab every 2 weeks for 8 weeks, then every 4 weeks up until 28 weeks

28 weeks

Visits at baseline, week 4, week 8, week 16, and week 28

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview

The study is testing a different schedule for taking Dupilumab to see if it works as well as the regular schedule for people with sinus issues and nasal polyps after surgery.

How Is the Trial Designed?

Group I: Arm B - Alternate Administration Experimental Treatment 1 Intervention

Eligible patient will receive 300 mg Subcutaneous Dupilumab every 2 weeks for 8 weeks and then every 4 weeks up until 28 weeks

Group II: Arm A - Regular Adminstration Active Control 1 Intervention

Eligible patient will receive 300 mg Subcutaneous Dupilumab every 2 weeks for 28 weeks

Who Is Running the Clinical Trial?

Madigan Army Medical Center

Lead Sponsor

Trials

52

Recruited

17,600+

William Beaumont Army Medical Center

Collaborator

Trials

18

Recruited

2,400+

Tripler Army Medical Center

Collaborator

Trials

23

Recruited

27,900+

Fort Belvoir Community Hospital

Collaborator

Trials

15

Recruited

2,100+

Published Research Related to This Trial

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]

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]

In a study of 66 patients with chronic rhinosinusitis with nasal polyps (CRSwNP), dupilumab significantly reduced symptoms and nasal polyp scores after 6 and 12 months, indicating its effectiveness as a treatment.

The safety profile of dupilumab was favorable, with only 12.7% of patients experiencing injection site reactions and 11.1% having transient hypereosinophilia, suggesting it is a safe option for managing CRSwNP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety Profile of Dupilumab in Chronic Rhinosinusitis with Nasal Polyps: Real-Life Data in Tertiary Care. Galletti, C., Barbieri, MA., Ciodaro, F., et al.[2023]

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 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]

In a study analyzing 911 adverse reactions associated with dupilumab for chronic rhinosinusitis with nasal polyps (CRSwNP), it was found that this treatment had fewer individual adverse reactions (iDAR) compared to treatments for asthma and atopic dermatitis, suggesting a favorable safety profile.

However, serious adverse reactions were reported in 13.3% of cases, with a notable risk among men and older adults, indicating that while dupilumab is generally safe, certain populations may experience more severe side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab Adverse Events in Nasal Polyp Treatment: Analysis of FDA Adverse Event Reporting System. Swisher, AR., Kshirsagar, RS., Adappa, ND., et al.[2022]

Dupilumab was found to be effective in treating severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP), showing significant improvements in nasal polyp scores and quality of life measures after just 15 days, which were sustained over 6 months.

The study involved 23 patients and reported only minor complications (26.1% of patients), indicating that dupilumab is a safe treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe chronic rhinosinusitis treated with dupilumab, a real-life analysis of early effectiveness. Mocellin, D., Ioppi, A., Gaglio, G., et al.[2023]

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