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
NCT Number: NCT06461949
Status: WITHDRAWN
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Allergic Fungal Rhinosinusitis (AFRS)|Chronic Rhinosinusitis (CRS)|Asthma|Nasal Polyps
Interventions: DRUG: Dupilumab
Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 0
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-17
Completion Date: 2024-07-17

Summary:
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.

Primary Outcome Measures: Efficacy of Dupilumab, -Control of sinonasal inflammation.-Prevention of nasal polyp recurrence after complete sinus surgery for AFRS.-Measured by change in the modified Lund-Kennedy (mLK) score., Change from baseline at 52 weeks
Secondary Outcome Measures: Effect of Dupilumab on Oral Corticosteroid Utilization, Reduction in the use of oral corticosteroids following complete sinus surgery for AFRS., Change from baseline at 52 weeks|Prevention of Revision Surgery for AFRS, Assessment of the need for additional surgery due to recurrent nasal polyps., Change from baseline at 52 weeks|Secondary Objective Measures of Sinonasal Inflammation, Changes in nasal polyp score (NPS) and CT-generated Lund-McKay score (LMS)., Change from baseline at 52 weeks|Lower Airway Dysfunction in Participants with Asthma, Spirometry measurements and other assessments in approximately 25% of participants with asthma, Change from baseline at 52 weeks|Health-Related Quality of Life, Upper and lower airway disease-specific quality of life measured by the Asthma Control Questionnaire (ACQ) and the Sinonasal Outcomes Test (SNOT-22)., Change from baseline at 52 weeks|Utilization of Rescue Medications, Reduction in the use of rescue medications for acute exacerbations of chronic rhinosinusitis (CRS) following sinus surgery., Change from baseline at 52 weeks