Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Oct 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called dupilumab for people with Aspirin-Exacerbated Respiratory Disease (AERD), which includes asthma and nasal polyps that can worsen with aspirin use. The goal is to see how effective dupilumab is and to understand how it works in the body. The study is currently looking for participants aged 18 to 75 who have a history of asthma and nasal polyps, as well as problems with their sense of smell. To join, participants should not have had any recent severe asthma issues or surgeries and should be using nasal steroid sprays consistently.

If you or someone you know qualifies and joins the trial, you can expect to receive the study treatment and be monitored closely by healthcare professionals. Participants will also need to follow specific guidelines, like practicing birth control if they are women of childbearing age. This study aims to improve understanding and treatment options for AERD, potentially leading to better management of symptoms and quality of life for those affected.

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Eligibility criteria

• Key Inclusion Criteria:
• 1. History of AERD, defined as meeting the diagnostic triad with:
• • 1. History of physician-diagnosed asthma and
• • 2. History of physician-diagnosed nasal polyposis and
• • 3. History of pathognomonic reactions to aspirin or other nonselective COX inhibitors.
• • 2. Visible nasal polyps bilaterally on otoscope physical exam at the time of screening.
• • 3. Evidence of sense of smell impairment, with a University of Pennsylvania Smell Identification Test (UPSIT) score of \<34.
• • 4. Stable asthma (no glucocorticoid burst for at least 4 weeks prior to Visit 1, and no hospitalizations or ER visits for asthma for at least the prior 3 months).
• • 5. Consistent (daily) use of an intranasal steroid for at least 4 weeks prior to Screening.
• • 6. No current smoking (not more than one instance of smoking in the last 3 months).
• • 7. For females: Practicing FDA-approved methods of birth control for the duration of the study. Female participants of childbearing potential must have a negative pregnancy test upon study entry.
• Key Exclusion Criteria:
• • 1. Use of investigational drugs within 12 weeks of Screening.
• • 2. Use of any biologic agent within 4 months prior to Screening.
• • 3. Use of systemic (enteral or injected) glucocorticoids within 4 weeks prior to Screening.
• • 4. History of any sinonasal surgery within 4 months prior to Screening
• • 5. Current use of zileuton
• • 6. Current use of high-dose aspirin therapy (no more than 325 mg aspirin per day will be allowed)
• • 7. Pregnant, nursing, or planning to become pregnant
• • Note: Other inclusion and exclusion criteria apply.