Dupilumab for Severe Eosinophilic Chronic Sinusitis
What You Need to Know Before You Apply
What is the purpose of this trial?
The investigators will investigate the efficacy of dupilumab in patients with severe eosinophilic CRSsNP who are resistant to the conventional treatment with intranasal corticosteroids and have significantly extensive disease involving more than 2 sinuses bilaterally in sinus CT scan and Lund-Mackay sinus (LMK) CT score \>=10 at baseline.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before joining. For example, you must not have taken biologic therapy or systemic immunosuppressants within 2 months before screening, and you must have been on a continuous treatment with leukotriene antagonists for at least 30 days prior to screening. Please check with the trial team for specific guidance on your current medications.
Is dupilumab safe for humans?
Dupilumab is generally considered safe for humans, with some patients experiencing mild side effects like injection site reactions and temporary increases in eosinophils (a type of white blood cell). It has been used safely in conditions like asthma, atopic dermatitis, and chronic rhinosinusitis with nasal polyps.12345
How does the drug Dupilumab differ from other treatments for severe eosinophilic chronic sinusitis?
What data supports the effectiveness of the drug Dupilumab for severe eosinophilic chronic sinusitis?
Who Is on the Research Team?
Seong Cho, MD
Principal Investigator
University of South Florida
Are You a Good Fit for This Trial?
Adults with severe eosinophilic chronic sinusitis without nasal polyps, who haven't improved after at least 8 weeks of standard nasal corticosteroid treatment. Participants must have a high Lund-Mackay CT score (≥10), significant blood eosinophils (≥200), and experience symptoms like nasal blockage or loss of smell. Excluded are those with certain other conditions, recent infections requiring antibiotics, immunodeficiencies, cancer history within 5 years, drug abuse in the past year, pregnancy, breastfeeding or participation in another clinical trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Dupilumab 300 mg every other week for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dupilumab
Dupilumab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of South Florida
Lead Sponsor