Treatment for Aspirin-Exacerbated Respiratory Disease using Dupilumab

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

This study is testing if a new treatment called dupilumab can help people with Aspirin-Exacerbated Respiratory Disease feel better and improve their symptoms.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Brigham and Women's Hospital (Academic / other)
• Drugs / interventions: dupilumab
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05575037 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and underlying mechanisms of dupilumab, an anti-IL-4a treatment, in patients suffering from Aspirin-Exacerbated Respiratory Disease (AERD). Participants will receive four doses of dupilumab over an 8-week period, with clinical assessments and biospecimen collections conducted at baseline, week 2, and week 8. The study focuses on individuals with a history of asthma, nasal polyps, and reactions to aspirin, assessing both clinical outcomes and biological responses to the treatment.

Who should consider this trial

Good fit: Ideal candidates include individuals with a confirmed diagnosis of AERD, visible nasal polyps, and stable asthma management.

Not a fit: Patients without a history of aspirin sensitivity or those with uncontrolled asthma may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve respiratory health and quality of life for patients with AERD.

How similar studies have performed: Previous studies have shown promise with dupilumab in similar conditions, indicating a potential for success in this approach.

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.

Where this trial is running

Boston, Massachusetts

• Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Tanya M Laidlaw, MD — Brigham and Women's Hospital
• Study coordinator: Tanya M Laidlaw, MD

Conditions Nasal Polyps; Asthma, Aspirin-Induced; Aspirin-Exacerbated Respiratory Disease; Aspirin-Sensitive Asthma With Nasal Polyps