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REGENERON (AIM4) ADULTS AND ADOLESENTS 12-80 YEARS OF AGE. 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) 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:
- 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:
- 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.
Explore More About These Research Trials
An easy way to track when your study milestones, treatments, or updates are expected.
Interested in hearing more about these Research Trials?
Please contact one of our staff at 502.368.0732 or fill out the form below: