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Study of Dupilumab 300 mg Every Other Week After Endoscopic Sinus Surgery in Patients With Allergic Fungal Rhinosinusitis (AFRS) on a Background Therapy With Intranasal Corticosteroid Spray

We are studying Dupilumab after sinus surgery for allergic fungal sinusitis.

Recruiting
18-99 years
All
Phase 3

Allergic Fungal Rhinosinusitis (AFRS) is a bad sinus infection where thick mucus and polyps block breathing. Surgery can help remove these polyps, but they often come back. This study tests a drug called Dupilumab, which might help people with AFRS after surgery. Participants must be 18 or older and have nasal polyps. Before surgery, they’ll have tests like imaging scans and an endoscopic exam (a tube with a camera and light put into the sinuses). After surgery, some will get Dupilumab injections, while others receive a placebo (a shot with no medicine). These self-administered injections happen every two weeks for a year.

  • The study lasts over a year, with injections every 2 weeks.
  • Participants won't know if they're getting the drug or placebo.
  • Follow-up lasts 12 weeks after treatment ends.

Participants will visit the clinic 16 weeks after surgery and report any side effects. Those who enroll must agree to certain conditions like avoiding pregnancy during the study and for 12 weeks after. This study helps researchers understand if Dupilumab can prevent polyps from coming back after surgery.

Study details
    Allergic Fungal Rhinosinusitis (AFRS)
    Chronic Rhinosinusitis (CRS)
    Asthma
    Nasal Polyps

NCT06461949

National Institute on Deafness and Other Communication Disorders (NIDCD)

8 July 2024

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