About Engage - Regeneron

What is the Engage clinical research study?

If you were diagnosed with eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD), please know that you are not alone in your medical journey. EoG is a chronic inflammatory disease in which large amounts of a type of white blood cell called eosinophils are found in the stomach, causing irritation and swelling. While EoG is rare, cases are on the rise, and it currently affects between 5-15 people in every 100,000 in the US.

Currently, we are working on developing potential treatments for EoG. Engage is a clinical research study that aims to assess the safety and efficacy of a study drug in treating EoG in adults and adolescents. Engage is made up of two study treatment periods. In the first period, you may receive either the study drug or a placebo. In the second period, all participants will receive the study drug.

What are the study drugs?

If you meet all the requirements to participate in this study, you may receive one of the following drugs:

The study drug: The study drug is a monoclonal antibody. Antibodies are proteins that your immune system produces and can be made in a lab to help you fight bacteria and viruses.

Placebo: A placebo is something that looks the same as the study drug and is given the same way but doesn’t have any active ingredients in it. Placebos are essential to clinical studies as they help test how effective an investigational drug may be. They help the researchers understand whether any changes seen during the study are due to the study drug or something else.

What can I expect if I participate?

Study participation is 100% voluntary (your choice). You will receive information on what to expect, as well as your role and responsibilities if you join the Engage clinical research study. You may leave the study at any time without it affecting your regular health care.

If you join the study, there are certain things you will be expected to do. This includes attending study visits and undergoing certain assessments and procedures, such as answering questions about your health and having an endoscopic biopsy. Depending on whether you continue on to participate in the second study period, your expected participation will last up to 70 weeks and will involve up to 20 visits.

The study drug, assessments, and procedures will be provided at no cost to you. The study team will discuss all of this with you.

In an endoscopic biopsy, a long, flexible, lighted tube called an endoscope is used to view the stomach, small intestine, and esophagus. During the endoscopy, small samples of the stomach, small intestine, and esophagus (in participants who also have eosinophilic esophagitis) are taken and then sent to a laboratory to be examined under a microscope.

How can I take part?

If you wish to take part in Engage, you can fill in a short pre-screener questionnaire to see if you may be eligible

What else should I know?

As with all medicines, there are possible risks when taking the study drug. If you qualify and choose to participate, you will be provided with an Informed Consent Form that explains any possible risks and side effects. It is also possible that the study drug may affect you in unknown ways. Your health and safety are our top priorities and will be closely monitored throughout your participation.

You may benefit from additional check-ups on top of your regular care and have access to EoG specialists. There is no guarantee that you will receive a medical benefit from participating in this study. Your condition may get better, stay the same, or may even get worse. You are free to withdraw from the study for any reason and at any time.

Find a study site near you

To find out more about Engage, and whether it may be right for you, please contact your closest study site – they will be more than happy to help.

Find your nearest study site