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Regeneron (AIM4) Asthma Study
If you are interested in participating and believe you meet the requirements, please contact our research staff to learn more at 502.368.0732.
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- Regeneron (AIM4) Asthma Study
REGENERON (AIM4) ADULTS AND ADOLESENTS 12-80 YEARS OF AGE. {ASTHMA STUDY}
- Randomly chosen to receive one of 2 study treatments:
- Dupilumab and the same inhaler you received
- Placebo injection and a higher dose of the asthma inhaler you received during the run-in period
- To evaluate the efficacy of dupilumab added to medium dose ICS/LABA in reducing severe asthma exacerbations in comparison to ICS dose escalation to high dose ICS-LABA in participants with uncontrolled asthma
- The duration of the study for a participant is approximately 58 weeks. The study is comprised of 3 periods: a screening period (2±1 weeks), a run in period (4+1 weeks), and a treatment period (52 weeks ± days). 9- will be clinical visits and 9 will be phone call visits.
Key Inclusion Criteria:
- Diagnosis of asthma for ≥12 months, Existing treatment with medium dose ICS/LABA (>250 to 500 μg/day of fluticasonepropionate DPI or equivalent, per GINA 2023 guidance document) for at least 3 months.
- History of ≥1 severe exacerbation(s) in the previous year before visit 1.
Key Exclusion Criteria:
- A participant with a diagnosis of COPD or other lung diseases.
- Weight is less than 30 kilograms
- Current smoker or cessation of smoking within 6 months prior to visit 1. Previous smokers with a smoking history ≥10 pack-years.
- Treatment with any biologic therapy/immunosuppressant/immunomodulator (including dupilumab) within 6 months.
Interested in This Research Study?
If you’d like to learn more or see whether you may be eligible to participate, please complete the brief interest form below. A member of our research team will follow up with next steps.
Research Study Interest Form
To learn more or express interest in this study, please complete the form below or contact our research team at 502-368-0732.