Considering treatment options for a recent type 1 diabetes diagnosis?

The investigational drug is designed to stop the immune system from attacking cells in the body that produce insulin. By stopping or limiting the immune system’s attack, the investigational drug may be able to help insulin production in patients who are in the early stage of type 1 diabetes.

Pharmaceutical companies conduct such studies to learn more about investigational drugs before they are made available to the public. The results of this study will provide more information about the drug’s safety. By taking part in this study, you will make an important contribution to research on early-stage type 1 diabetes.

Imcyse is a clinical-stage biotech company headquartered in Liège, Belgium, created in 2010 as a spin-off of the Catholic University of Leuven (KULeuven). Imcyse’s mission is to develop novel, disease-specific immune therapies to cure and prevent severe, chronic auto-immune, inflammatory and allergic diseases.

What is a clinical study?

• A clinical study is a scientific study on how a new or existing medicine, product, procedure or treatment works in people.
• Through clinical studies, doctors can find new and better ways to prevent, detect, diagnose, control and treat illnesses.
• All clinical studies are carefully monitored and regulated to ensure participant well-being.
• Participating in a clinical study is completely voluntary and will not affect the normal standard of care you receive.

What is the study about?

As someone who has been recently diagnosed with type 1 diabetes, you’re likely learning about treatment options that will help manage your disease. Your diabetes has developed because your body’s immune system began attacking certain cells in your pancreas that help make insulin. Currently, there is no cure or treatment that can alter the effects of your type 1 diabetes, which means you need insulin shots to help control your blood sugar. 

One option to consider is this research study of an investigational drug that is being evaluated as a ‘therapeutic vaccine’. This type of product has the potential to positively affect the body’s erroneous immune system response which has caused a medical condition or disease, in your case type 1 diabetes.

In this study, doctors primarily want to evaluate the safety of three different doses of the investigational drug in patients who have recently been diagnosed with type 1 diabetes. They also want to collect first evidence of the efficacy of this new approach. They want to compare these doses with a placebo, which looks like the investigational drug, but contains no active medication.

Eligible patients will receive a total of 4 injections over 6 weeks. The results of this study will provide more information about the investigational drug and its effect on recently diagnosed type 1 diabetes.

What will happen during this study?

Before you can participate in this study, you will be screened for eligibility. If you are eligible, and you agree to participate, you will be randomly assigned (like flipping a coin) to receive injections of either the investigational drug or the placebo. You have a 75% chance of receiving the investigational drug and a 25% chance of receiving the placebo.

You will also continue to take your daily insulin, which is currently the standard therapy. Your participation in the study will last approximately 24 weeks in total, which includes screening, treatment, and a follow-up visit.

During your clinic visits for the study, doctors and the study staff will also conduct various tests and assessments to evaluate your health and progress. Some of these tests and assessments include, but are not limited to:

• Review of your type 1 diabetes and general medical history
• Vital signs measurements
• Physical exams
• Blood and urine sample collections
• Injection site exams
• Reviews of your insulin use
• Reviews of medication you are taking
• Reviews of any side effects

If you join the study, you can stop taking part at any time. If you choose to leave the study, doctors and the study staff will ask you to undergo some tests and assessments so they can evaluate your safety.

What are the risks and benefits related to this study?

As with any research study, your type 1 diabetes may or may not improve as a result of your participation in this study. The investigational drug used has not been evaluated in humans before as part of a research study. Therefore, not all side effects are known. 

It is possible you could experience a side effect while in this study. Some of the most common side effects related to injections are redness, inflammation, and swelling at the injection site; very similar to what happens with classical vaccinations. The study staff will provide you with a complete list of known side effects related to this product.

Because research studies can affect the health and safety of participants, you will be closely monitored during this study. Researchers designed a protocol for this study, which explains all of the study procedures in complete detail. An independent review board responsible for participant safety reviewed and approved this protocol and requires that it be followed exactly.

What if I have questions?

The study staff is always available to answer any questions or concerns you may have about the study or the investigational drug.