About the Amagine Clinical Trial
Doctors and researchers want to learn more about brodalumab when it is given to individuals with moderate to severe plaque psoriasis.
Because current psoriasis treatments do no provide relief for all patients, investigational medication options are being studied today. The Amagine psoriasis clinical trial is evaluating brodalumab as an investigational medication for moderate to severe plaque psoriasis.
Through this study, doctors hope to learn more about the safety and effectiveness of brodalumab when given to subjects with moderate to severe plaque psoriasis. The results of Amagine will provide doctors with more information about brodalumab and whether it could one day be used to treat psoriasis.
About the Treatment Medication
Brodalumab is a type of protein that is designed to block the interaction of other proteins in the body that can cause inflammation and symptoms related to psoriasis.
By preventing the interaction of these proteins related to psoriasis, brodalumab is being investigated to see if it may be able to help treat psoriasis.
About Participating in the Amagine Clinical Trial
If you are eligible and agree to participate, you will be randomly placed (like the flip of a coin) into 1 of 4 study groups for the first 3 months of the study. Two groups will receive brodalumab, a third group will receive ustekinumab (also known as Stelara®, a marketed drug used to treat psoriasis), and the fourth group will receive placebo, which contains no active ingredients. Because of the way the study is designed, you will have a 1 in 6 chance of receiving placebo during the first 3 months.
After the first three months, if you were previously receiving brodalumab, you will be randomly placed to receive brodalumab at various frequencies. If you were previously receiving placebo, you will receive brodalumab, and if you were previously on ustekinumab (Stelara®), you will remain on ustekinumab (Stelara®) until you have been receiving it for approximately 1 year, then you will receive brodalumab thereafter.
The study is blinded for the first year. That means that you, the study site, the study doctor and the sponsor will not know which treatment you are on.
You will need to visit the clinic regularly throughout the 5-year duration of the study. During these visits, study doctors will provide you with your study medication and will also evaluate your health and progress through various study-related tests and assessments.
If you choose to participate, you may leave Amagine at any time and for any reason. You do not have to participate in Amagine. There are treatment options available for psoriasis that you can discuss with your doctor.
Benefits of Participating in the Amagine Clinical Trial
Pharmaceutical companies use clinical research studies like this one to learn more about investigational medications to see if they can be made available to the public. The results of these studies provide them with more information about the safety and effectiveness of the investigational medications being evaluated.
By taking part in Amagine, you will be making an important contribution to psoriasis research.
To sign up for a plaque psoriasis study and talk to a study coordinator, please fill out the Sign Up for a Study form or call Advanced Clinical Care at 508-755-0201.