A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS MAINTENANCE THERAPY FOR MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE
This study is investigating a new drug called Ozanimod for individuals living with Crohn's disease that is moderately to severely active. Crohn's is a long-term condition that causes inflammation in the digestive system. The main goal is to find out if Ozanimod, taken as a capsule, can help people stay well and keep their symptoms, like stomach pain and frequent bowel movements, under control for a whole year. Researchers are also checking if the medication can reduce inflammation in the gut lining, which they'll look at using special procedures. The study is a Phase 3 trial, meaning it's one of the final steps to see if the medicine is safe and effective before it can be considered for wider use.
At a glance
What is this study about?
This research study is focused on people who have Crohn's disease that is currently troubling them quite a bit, meaning it's 'moderately to severely active.' Crohn's is a type of inflammatory bowel disease (IBD) that causes inflammation, swelling, and irritation in different parts of your digestive system. This can lead to symptoms like stomach pain, diarrhoea, tiredness, and weight loss. Doctors are always looking for better ways to manage Crohn's and help people live more comfortably.
The study is testing a new medication called Ozanimod, which comes in a capsule form. The main things the doctors want to find out are whether Ozanimod can help keep Crohn's symptoms under control for a long time – specifically, for 52 weeks (about a year). They'll be looking to see if your symptoms improve enough so that you feel much better. They also want to understand if the medication can help reduce the inflammation and damage in your intestines, which is a key part of managing Crohn's disease.
This is a 'Phase 3' study, which means it's a large and important step. It compares Ozanimod to a 'placebo,' which looks exactly like the real medicine but doesn't contain any active drug. This helps the researchers understand if any improvements are genuinely due to Ozanimod or if they might happen anyway. If this study shows that Ozanimod is safe and works well, it could become a new treatment option for people with Crohn's disease in the future.
Key takeaways
- Tests a new Crohn's drug, Ozanimod, for active disease.
- Aims to control symptoms and reduce gut inflammation over one year.
- Compares Ozanimod to a dummy pill (placebo).
- Requires regular clinic visits and health checks.
- Open to adults (18+) with moderate to severe Crohn's.
Who may be eligible?
To take part in this study, you must be at least 18 years old. Both men and women can join. The study is specifically for people who have been diagnosed with Crohn's disease that is currently active and causing you significant problems, rather than a mild form.
While the study accepts a wide range of ages, there are other important health details that the study doctors will check to make sure the trial is safe and suitable for you. These can include your medical history, any other health conditions you might have, and medications you are currently taking.
It’s important to talk to your GP or Crohn's specialist if you are interested in this study, as they can help determine if it matches your individual health situation and if you meet all the specific requirements.
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 Crohn's disease?
- Is your Crohn's disease currently 'moderately to severely active'?
- Are you able to attend regular clinic appointments for about one year?
What does participation involve?
If you decide to take part in this study, you would receive either the new drug Ozanimod or a matching dummy pill (placebo) in capsule form. You would take this medication regularly over approximately one year. Throughout this time, you would have regular visits to the study clinic. These visits would involve various assessments, such as physical examinations, blood tests, and discussions about your symptoms and how you are feeling.
To check the health of your gut and how the treatment is working, you would also have specific procedures, likely including endoscopies (where a small camera is used to look inside your digestive system). These assessments help the researchers understand if the medication is reducing inflammation. The total duration of active participation in the study, including treatment and assessments, would be around 52 weeks, with potentially some follow-up after that.
Potential risks and benefits
Locations (14)
- —UnverifiedFrance
- —UnverifiedBulgaria
- —UnverifiedCzechia
- —UnverifiedCroatia
- —UnverifiedSlovakia
- —UnverifiedLatvia
- —UnverifiedRomania
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedIreland
- —UnverifiedItaly
- —UnverifiedHungary
Common questions
What is Ozanimod?
Ozanimod is a new medication being tested in capsule form, aimed at helping people with active Crohn's disease.
What is a 'placebo'?
A placebo is a fake medicine that looks just like the real drug but contains no active ingredients. It helps researchers see if the real drug is truly effective.
How long will the study last?
Active participation in the study, including taking medication and having assessments, will last for about one year (52 weeks).
Will I know if I'm getting the real drug or the placebo?
No, this is a 'double-blind' study, meaning neither you nor the study doctors will know who is receiving Ozanimod and who is receiving the placebo until the study is over.
Who can join the study?
The study is for adults aged 18 and over who have moderately to severely active 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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