Understanding how Dupilumab affects Aspirin-Exacerbated Respiratory Disease
Mechanisms of Dupilumab in AERD - Effects on Aspirin Hypersensitivity Response, With a Focus on Innate Type 2 Inflammatory Responses
PHASE2 · Scripps Clinic · NCT05031455
This study is testing how the medication Dupilumab affects people with Aspirin-Exacerbated Respiratory Disease when they are given aspirin to see if it helps reduce their reactions.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Scripps Clinic (other) |
| Drugs / interventions | dupilumab, omalizumab, tezepelumab, mepolizumab, reslizumab, benralizumab |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT05031455 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the mechanisms by which Dupilumab, a biologic medication, influences the treatment of Aspirin-Exacerbated Respiratory Disease (AERD). AERD is a severe form of asthma and nasal polyposis that can be triggered by aspirin. The study involves administering an aspirin challenge to patients who have been treated with Dupilumab for at least 12 weeks to assess the medication's impact on hypersensitivity reactions. The goal is to better understand how Dupilumab interacts with aspirin desensitization therapy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a confirmed diagnosis of Aspirin-Exacerbated Respiratory Disease who have been on Dupilumab for at least 12 weeks.
Not a fit: Patients with a history of severe gastrointestinal reactions to NSAIDs or unstable asthma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies for patients with AERD, potentially improving their quality of life.
How similar studies have performed: While there is existing knowledge about aspirin desensitization in AERD, the specific interaction with Dupilumab is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects \>18 years old with Aspirin-Exacerbated Respiratory Disease This is diagnosed via either a positive oral aspirin or intranasal ketorolac challenge OR a history of at least two stereotypical hypersensitivity reactions to aspirin leading to nasal-ocular symptom and/or asthmatic symptoms. * Current treatment with dupilumab at standard asthma/nasal polyposis dosing of 300mg subcutaneously every 2 weeks for a minimum of 12 weeks. * All subjects will be required to have a known history of nasal polyposis either via imaging, endoscopy, or nasal examination Exclusion Criteria: * History of gastrointestinal reactions (severe abdominal pain with or without vomiting) during NSAID triggered events * Unstable asthma or history of severe reactions during previous desensitization attempts * inability to take montelukast pretreatment * history of gastrointestinal bleeding or bleeding disorder * pregnancy * previous use of any other respiratory biologic in the past 3 months (omalizumab, tezepelumab, mepolizumab, reslizumab, benralizumab) * need for systemic corticosteroids to stabilize asthma prior to challenge * time from sinus surgery \<1 month.
Where this trial is running
San Diego, California
- Scripps Clini — San Diego, California, United States (RECRUITING)
Study contacts
- Study coordinator: Andrew White, MD
- Email: white.andrew@scrippshealth.org
- Phone: 858-764-9010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aspirin-exacerbated Respiratory Disease