Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease (NCT05575037) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease
United States17 participantsStarted 2023-08-01
Plain-language summary
The overall aim of the study is to determine the clinical efficacy and mechanisms of action of anti-IL-4a (dupilumab) as treatment for patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) and Aspirin-Exacerbated Respiratory Disease (AERD).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. History of AERD, defined as meeting the diagnostic triad with:
✓. History of physician-diagnosed asthma and
✓. History of physician-diagnosed nasal polyposis and
✓. History of pathognomonic reactions to aspirin or other nonselective COX inhibitors.
✓. Visible nasal polyps bilaterally on otoscope physical exam at the time of screening.
✓. Evidence of sense of smell impairment, with a University of Pennsylvania Smell Identification Test (UPSIT) score of \<34.
✓. 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).
✓. Consistent (daily) use of an intranasal steroid for at least 4 weeks prior to Screening.
Exclusion criteria
✕. Use of investigational drugs within 12 weeks of Screening.
✕. Use of any biologic agent within 4 months prior to Screening.
✕. Use of systemic (enteral or injected) glucocorticoids within 4 weeks prior to Screening.
✕. History of any sinonasal surgery within 4 months prior to Screening