Trials / Active Not Recruiting
Active Not RecruitingNCT05575037
Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease
Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease: MARINER
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Brigham and Women's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
The protocol involves an 8-week study of dupilumab in patients with CRSwNP and/or AERD. Participants will have 4 total doses of dupilumab administered, with each dose administered every 2 weeks. There will be full clinical assessments and biospecimen collections at Baseline (Visit 1), Week 2 (Visit 2), and Week 8 (Visit 3).
Conditions
- Nasal Polyps
- Asthma, Aspirin-Induced
- Aspirin-Exacerbated Respiratory Disease
- Aspirin-Sensitive Asthma With Nasal Polyps
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dupilumab | 8-week trial of dupilumab (an anti-IL-4a) in patients with AERD. |
Timeline
- Start date
- 2023-08-01
- Primary completion
- 2026-04-30
- Completion
- 2026-04-30
- First posted
- 2022-10-12
- Last updated
- 2025-09-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05575037. Inclusion in this directory is not an endorsement.