FAQs
What is a clinical research study?
A clinical research study is a medical research study in people. The potential new treatment or device being studied only enters a clinical study after researchers test it in the laboratory. If it looks promising, scientists carefully test and collect data about the potential drug through clinical studies. A clinical study helps us learn how an investigational drug works in the body. Clinical studies must be reviewed by a regulatory agency. In the United States, it’s the Food and Drug Administration (FDA). In Europe, it’s the European Medicines Agency (EMA). Agencies vary by region. They decide whether to approve the investigational drug for doctors to prescribe.
The first step is discovering and developing a new investigational medicine to study. After that, clinical studies show if it is well-tolerated and effective and provide information on any side effects. Sometimes, researchers compare the potential medicine to a placebo. The placebo looks and is administered like the potential treatment but has no active ingredients. The potential treatment may also be compared to a standard treatment that is already approved and used for treatment. They compare it to current treatments, if available, to find out if the potential treatment is better or just as effective and well-tolerated.
Where can I learn more about EoG and find out more about my options?
Eosinophilic gastritis is a rare disease, but that doesn’t mean you’re alone. Patient advocacy groups exist to connect and support people with EoG.
American Partnership for Eosinophilic Disorders (APFED)
Why is diversity in clinical studies important?
Diversity in clinical studies ensures researchers learn how potential treatments work for everyone. To learn more about diversity in clinical studies and why it matters, please download the brochures below.
What is the Engage clinical research study?
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.
Am I eligible to take part in the Engage study?
Are ≥ 12 years old
How many people will be taking part in the Engage clinical research study?
Approximately 279 people globally are expected to take part in Engage.
What are my responsibilities if I take part?
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 undergoing an endoscopic biopsy.
How long will the study last?
Depending on whether you continue on to take part in Part C, your expected participation will be up to 70 weeks and will involve up to 20 visits.
What are potential benefits from joining?
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.
What are potential risks to joining?
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.
Where is the study taking place?
The Engage clinical study is taking place at many sites globally.
You can use our site finder tool to find the closest site to you.
What do I do if I have other questions?
If you have more questions about the Engage clinical study, please contact the site closest to you. You can find out which site is closest by using our site finder tool.