A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
This research is an ongoing study exploring a medicine called ozanimod for adults living with moderate to severe Crohn's disease. Participants have already taken part in a previous study with ozanimod and are continuing to receive the treatment. The main goal is to understand how well ozanimod helps to improve symptoms like tummy pain and frequent bowel movements, and to see if it helps the gut to heal over time. Doctors will be checking various health markers, including looking inside the gut, and monitoring general well-being. Additionally, the study will investigate how having had COVID-19 or the COVID-19 vaccine might affect people taking ozanimod for Crohn's disease, by checking for COVID-19 antibodies regularly.
At a glance
What is this study about?
This study is an important project looking into a medicine called ozanimod for people who have Crohn's disease that is moderate to severe. Crohn's disease is a long-term condition where parts of the digestive system become inflamed, which can cause symptoms like tummy pain, diarrhoea, and feeling very tired. The main aim of this study is to see how well ozanimod helps to manage these symptoms and improve the health of the gut over a long time.
Researchers will be carefully tracking many different things. They want to see if people feel better, have less pain, and fewer bowel movements. They will also look at how much the inflammation in the gut improves, sometimes by doing tests that show what the inside of the digestive system looks like. This helps them understand if the medicine is not just making symptoms better, but also helping the gut to heal. The study is called an "open-label extension," which means participants already know they are receiving ozanimod because they were part of an earlier study.
Another interesting part of this research is that it will also look at how COVID-19 might affect people with Crohn's disease who are taking ozanimod. They will regularly check for antibodies to COVID-19 in participants to see if having had the virus or the vaccine has any connection to how the medicine works or how Crohn's disease progresses. This will help doctors understand more about treating Crohn's disease in the context of other health concerns like COVID-19.
Key takeaways
- This study is an ongoing look at ozanimod for moderate to severe Crohn's disease.
- It's for people already in a previous study on ozanimod.
- The main goals are to check if symptoms improve and gut health gets better over time.
- Researchers will also monitor COVID-19 antibody levels.
- Regular clinic visits and assessments will be part of taking part.
- The study aims to understand the long-term effects of the medicine.
Who may be eligible?
To be part of this study, you need to be an adult, aged 18 or older. Both men and women can take part. You must also have been diagnosed with moderate to severe Crohn's disease.
Crucially, this study is for people who have already taken part in a previous study with ozanimod for Crohn's disease. It's designed to continue monitoring your health and the effects of the medicine for a longer period. If you haven't been in the earlier study, you won't be able to join this particular one.
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?
- Have you been diagnosed with moderate to severe Crohn's disease?
- Have you already participated in an earlier study involving ozanimod?
- Are you able to attend regular clinic visits for health checks?
What does participation involve?
If you take part in this study, you will continue to receive the medicine ozanimod, usually taken by mouth. You will have regular visits to the clinic where doctors and nurses will check on your health and how you are feeling. These checks will include answering questions about your symptoms, like tummy pain and how often you need to use the toilet. You might also have blood tests, stool (poo) samples, and sometimes procedures to look inside your gut to see how it's healing, such as an endoscopy.
During your visits, they will also take blood samples to check for COVID-19 antibodies. The study aims to follow participants for a long time – with checks every 48 weeks – to see the long-term effects of ozanimod. The total duration of your participation will depend on how long you continue to benefit from and want to remain on the study drug, as this is an extension study.
Potential risks and benefits
Locations (15)
- —UnverifiedGermany
- —UnverifiedHungary
- —UnverifiedSlovakia
- —UnverifiedItaly
- —UnverifiedNetherlands
- —UnverifiedIreland
- —UnverifiedRomania
- —UnverifiedPortugal
- —UnverifiedCzechia
- —UnverifiedCroatia
- —UnverifiedPoland
- —UnverifiedSpain
Common questions
What is ozanimod?
Ozanimod is a medicine being studied for moderate to severe Crohn's disease to help reduce inflammation and symptoms.
Who can join this study?
Adults (18+) with moderate to severe Crohn's disease who have already taken part in a previous ozanimod study are eligible.
Will I know if I'm getting the real medicine?
Yes, this is an 'open-label' study, meaning all participants know they are receiving ozanimod.
How often will I need to visit the clinic?
You'll have regular check-ups, usually every 48 weeks, to monitor your health and the medicine's effect.
What's the purpose of checking for COVID-19 antibodies?
Researchers want to understand how previous COVID-19 infection or vaccination might affect people taking ozanimod for Crohn's disease.
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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