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

Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study ID
NCT06461949
Phase
PHASE3
Status
Withdrawn

Conditions

  • Allergic Fungal Rhinosinusitis (AFRS)
  • Asthma
  • Chronic Rhinosinusitis (CRS)
  • Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Dupilumab (Dupixent) is a human monoclonal antibody administered via subcutaneous injection to treat various conditions such as Chronic Rhinosinusitis with Nasal Polyps, Asthma and Eosinophilic Esophagitis.

Study Details

Background: Allergic fungal rhinosinusitis (AFRS) is a severe type of sinus infection. People with AFRS develop heavy mucus and growths called polyps that apply pressure to the sinuses and block their breathing. Surgery can remove the polyps, but they often grow back. Researchers want to test an approved drug they believe may help people with AFRS. Objective: To test a drug (Dupilumab) in people with AFRS. Eligibility: People aged 18 years or older with suspected AFRS who are scheduled to undergo surgery for nasal polyps. Design: Participants will have several tests before their surgery. They will have imaging scans of their sinuses. They will have an endoscopic exam: A tube with a camera and a light will be inserted into their sinuses. They may give blood and mucus samples. They will have standard treatment with nasal sprays for 2 to 6 weeks before their surgery. Excess nasal tissue removed during the surgery will be collected for research. Then they will begin treatment with the study drug. Dupilumab is injected under the skin. Some participants will receive the study drug. Some will receive a placebo injections. The placebo injections are just like the study drug but contain no medicine. Participants will not know which injections they are getting. All participants will administer the injections to themselves at home. They will do this every 2 weeks for 1 year after the surgery. They will have a clinic visit 16 weeks after surgery. Participants will have follow-up for 12 weeks after treatment ends.

Key Dates

Start date
Jul 17, 2024
Status verified
Jul 2024
Primary completion
Jul 17, 2024
Completion
Jul 17, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A:
    Treatment: Dupilumab 300 mg administered subcutaneously every two weeks for 52 weeks.
  • Placebo Comparator: Arm B:
    Control: Placebo administered subcutaneously every two weeks for 52 weeks.

Primary Outcome Measure

Efficacy of Dupilumab [ Time Frame: Change from baseline at 52 weeks ]

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