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

Prior treatment

• 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
• Current use of high-dose aspirin therapy (no more than 325 mg aspirin per day will be allowed)

Other

• Current use of zileuton
• Pregnant, nursing, or planning to become pregnant
  • Note: Other inclusion and exclusion criteria apply.

• 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.
• No current smoking (not more than one instance of smoking in the last 3 months).
• 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.