30 Participants Needed

Dupilumab for Nasal Polyps

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Madigan Army Medical Center
Must be taking: Intranasal corticosteroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

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 data supports the effectiveness of the drug Dupilumab for nasal polyps?

Dupilumab has been shown to improve nasal polyp size, sinus clarity, and quality of life in patients with chronic rhinosinusitis with nasal polyps. It also helps relieve symptoms like nasal congestion and reduces the need for surgery and additional medications.12345

Is Dupilumab safe for treating nasal polyps?

Dupilumab is generally considered safe for treating nasal polyps, with some patients experiencing mild reactions like injection site reactions and temporary increases in certain blood cells. Further studies are needed to understand long-term effects.16789

How does the drug Dupilumab differ from other treatments for nasal polyps?

Dupilumab is unique because it is the first biological therapy approved for severe uncontrolled chronic rhinosinusitis with nasal polyps, working by blocking specific proteins (IL-4 and IL-13) that drive inflammation. It is administered as a subcutaneous injection every two weeks and has been shown to reduce the need for surgery and oral corticosteroids, while improving symptoms and quality of life.1231011

What is the purpose of this trial?

Investigators will investigate an alternate Dupilumab administration schedule in patients with recurrent chronic rhinosinusitis with nasal polyposis, who have a history of full endoscopic sinus surgery and are on appropriate topical medical therapies. Specifically, investigators will investigate if the alternate schedule of drug administration is non-inferior in both subjective and objective outcomes.

Research Team

RM

Renee M Serra, MD

Principal Investigator

ENT/Audiology Department Chair

RF

Roy F Thomas, MD

Principal Investigator

Rhinologist

Eligibility Criteria

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.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B - Alternate AdministrationExperimental Treatment1 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 AdminstrationActive Control1 Intervention
Eligible patient will receive 300 mg Subcutaneous Dupilumab every 2 weeks for 28 weeks

Find a Clinic Near You

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+

Findings from Research

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

References

Dupilumab's Impact on Blood Parameters in Nasal Polyposis: 18-Month Follow-Up in Real Life. [2023]
Dupilumab: A Review in Chronic Rhinosinusitis with Nasal Polyps. [2022]
Real-world evidence for the effectiveness and safety of dupilumab in patients with CRSwNP after 1 year of therapy. [2023]
The "real life" efficacy of dupilumab is independent of initial polyp size and concomitant steroids in CRSwNP. [2023]
Rapid and Continuing Improvements in Nasal Symptoms with Dupilumab in Patients with Severe CRSwNP. [2022]
Effectiveness and Safety Profile of Dupilumab in Chronic Rhinosinusitis with Nasal Polyps: Real-Life Data in Tertiary Care. [2023]
Dupilumab Adverse Events in Nasal Polyp Treatment: Analysis of FDA Adverse Event Reporting System. [2022]
Severe chronic rhinosinusitis treated with dupilumab, a real-life analysis of early effectiveness. [2023]
Dupilumab in chronic rhinosinusitis with nasal polyps: Real life data in a multicentric Sicilian experience. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
The role of intranasal corticosteroids in chronic rhinosinusitis with nasal polyposis treated with dupilumab. [2023]
Effectiveness of Dupilumab in the Treatment of Patients with Severe Uncontrolled CRSwNP: A "Real-Life" Observational Study in the First Year of Treatment. [2022]
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