Dupilumab for Nasal Polyps
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?
Is Dupilumab safe for treating nasal polyps?
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
Renee M Serra, MD
Principal Investigator
ENT/Audiology Department Chair
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 300 mg Subcutaneous Dupilumab every 2 weeks for 8 weeks, then every 4 weeks up until 28 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dupilumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Madigan Army Medical Center
Lead Sponsor
William Beaumont Army Medical Center
Collaborator
Tripler Army Medical Center
Collaborator
Fort Belvoir Community Hospital
Collaborator