"A PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS"
This research study is looking into a medicine called Cendakimab (also known as CC-93538) for a condition called Eosinophilic Esophagitis. This condition can affect the food pipe (oesophagus) and make it difficult to swallow. The main goal of this study is to understand how safe this medicine is over a long time. Researchers will keep a close eye on participants for any side effects, changes in lab tests like blood samples, and other health signs. This is a follow-up study, meaning participants usually would have been in an earlier trial for the same medicine. The aim is to gather more information about its safety when used for longer periods.
At a glance
What is this study about?
This study is about a challenging condition called Eosinophilic Esophagitis, often shortened to EoE. It's an allergic condition where a type of white blood cell, called eosinophils, builds up in the lining of the food pipe. This can cause inflammation and make it hard to swallow food, leading to pain and discomfort. Doctors are trying to find new and safe ways to manage this condition, and one of the medicines they are studying is called Cendakimab (you might also see it referred to as CC-93538).
This particular study is designed to learn more about the long-term safety of Cendakimab. It’s called an "open-label extension study," which means that everyone taking part will receive the Cendakimab medicine, and both you and the study team will know you're getting it. The main focus is to see if there are any unexpected or significant side effects that might only show up after taking the medicine for a longer time. Understanding long-term safety is a really important step before a new medicine can be widely used.
The information gathered from this study will help doctors understand if Cendakimab is a good and safe option for people with EoE to use over many months or even years. They'll be carefully checking lots of health signs, including any side effects, changes in routine blood tests, and overall well-being. They will also look at how your body reacts to the medicine and if it produces any antibodies against it, which is a normal process your immune system might do when it encounters a new substance.
Key takeaways
- This study is for adults with Eosinophilic Esophagitis (EoE).
- It's testing the long-term safety of a medicine called Cendakimab.
- All participants will receive the study medicine.
- Your health will be carefully watched for side effects over time.
- This research helps doctors understand if the medicine is safe for long-term use for EoE.
Who may be eligible?
This study is looking for adults who are at least 18 years old. People of all genders can take part.
It's important to know that this study is likely for people who have already been part of an earlier study looking at the same medicine. This is because it’s an "extension study" to understand the long-term effects, so participants would typically have started the treatment in a previous trial.
Specific medical details about your health and your EoE condition would need to be checked by the study team to see if you are a good fit. They will make sure the study is safe and appropriate for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have Eosinophilic Esophagitis?
- Have you previously taken part in a study for Cendakimab (CC-93538)?
- Are you able to attend regular clinic visits?
- Are you comfortable with regular health checks, including blood tests?
What does participation involve?
If you decide to take part, you would receive the study medicine, Cendakimab, regularly. The study team will schedule visits to the clinic where they will carefully monitor your health. These visits will involve various health checks, such as measuring your vital signs (like blood pressure and heart rate), routine physical examinations, and taking blood samples for lab tests. You'll also be asked about any side effects or changes you notice in your health.
The study is designed to look at the long-term use of the medicine, so it could last for an extended period. The exact number of visits and the total duration would be explained in detail by the study team if you are considered for participation. Throughout your time in the study, you'll have close contact with the medical staff who can answer your questions and address any concerns.
Potential risks and benefits
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Common questions
What is Eosinophilic Esophagitis (EoE)?
It's an allergic condition where specific white blood cells build up in the food pipe, causing inflammation and making it hard to swallow.
What is Cendakimab?
It's a new medicine being studied to treat Eosinophilic Esophagitis. It's also called CC-93538.
Why is this study important?
It helps doctors understand how safe Cendakimab is when used for a long time, which is key for potential future treatments.
Will I definitely get the study medicine?
Yes, in this type of study (open-label extension), all participants receive the Cendakimab medicine.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time without having to give a reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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