Why is This Study Being Conducted?
The purpose of this study is to evaluate the safety, tolerability and effectiveness of Dupilumab, the investigational medication, compared to placebo, for moderate to severe, uncontrolled asthma. Dupilumab or placebo will be given by injection under the skin every 2 weeks (every 14 days) for 24 weeks. The placebo looks like Dupilumab, but does not contain the real drug.
You will be randomly (by chance, similar to a flip of a coin) assigned to receive one of four different doses and regimens of Dupilumab or placebo. You will receive an injection under the skin every 2 weeks for 24 weeks. During the entire study, you will continue to use your asthma control inhaler and your asthma relief inhaler as instructed by your study doctor.
Why Participate In a Clinical Research Study?
Millions of people enroll in clinical studies every year. The reasons they choose to take part are as unique and varied as the people themselves. Some people enroll to help find a potential future treatment or to support medical science. Others enroll to learn new information about their medical condition. The reasons you may consider participating are yours alone. You should only decide once you have learned all about the clinical research study.
If you enroll in the asthma study, you will see the study doctor regularly. You will also receive counseling on ways to avoid asthma triggers and promote better breathing.
Description of the Study
This study is a double-blind study, meaning that neither you nor the study doctor or staff will know who is receiving Dupilumab or placebo.
Patients enrolling in this study must meet certain requirements. The study doctor will review all of the restrictions and requirements of the study with you, to determine if you qualify to be in the study and to answer your questions.
How Long Will I Be In The Study?
You can expect to spend 42 to 43 weeks in the study.
May I Withdraw From The Study If I Change My Mind?
Yes, your participation in the asthma study is voluntary. You may withdraw from the study before study completion if you decide to do so, at any time and regardless of the reason. If you come to this decision, please let your study team know. If possible, you will be assessed using the procedure normally planned for the End-of-Study Dosing Visit and the four Post-Dosing Visits.
May I Continue to Use My Primary Care Provider While I'm In The Study?
Yes. Having your primary healthcare provider work with the study team helps to ensure other treatments will not conflict with the study drug.
Please inform the study team about all prescription and over-the-counter drugs you take or intend to take while in the study. This includes vitamins and herbal supplements.
If you are interested in participating, prequalify online here.
