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

• Status: Not yet recruiting
• Trial end date: 2027-11-01
• Target enrollment: 0
• Participant gender: All

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 Aspirin-Exacerbated Respiratory Disease (AERD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Antibodies, Monoclonal

Criteria

Key Inclusion Criteria:

1. A Body Mass Index (BMI) of >18.0 kg/m2

2. 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.

3. Visible nasal polyps bilaterally on rhinoscopy at the time of Screening, with a Total Polyp Score (TPS) 1 of >2 on each side, for a minimum total score of 4 (out of 8 maximum).

4. Evidence of sense of smell impairment, with a University of Pennsylvania Smell Identification Test (UPSIT) score of <34.

5. Stable asthma (pre-bronchodilator FEV1 of >60% predicted, 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 6 months).

6. Consistent (daily) use of an intranasal steroid for at least 4 weeks prior to Screening.

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

8. 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.

9. For males: Practicing FDA-approved methods of birth control for the duration of the study.

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 randomization/Visit 1

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.