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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

NCT06461949 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-07-25

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Dupilumab

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.

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    lead NIH

Principal Investigators

  • Joshua Levy, M.D. · National Institute on Deafness and Other Communication Disorders (NIDCD)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-17
Primary Completion
2024-07-17
Completion
2024-07-17
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06461949 on ClinicalTrials.gov