A 14-Week Phase 2b, RandomizEd, Double-BLind, Dose-Ranging Study to Determine the PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (RELIEVE UCCD)
This research study, called RELIEVE UCCD, is investigating a new medication, TEV-48574, for people aged 18 and over who have moderate to severe Crohn's disease or ulcerative colitis. It's a phase 2 study, meaning we're still in the earlier stages of understanding the new medicine's effects. Participants will be randomly given either the new medicine or a 'dummy' medicine (placebo) without knowing which one they receive. The main goals are to find out if the medicine helps improve symptoms, how safe it is, and how the body uses and gets rid of it. This information is crucial for deciding if the medicine should be studied further to help people with these conditions.
At a glance
What is this study about?
This study is a clinical trial, which is a type of research carried out with people to test new treatments. The treatment being tested here is a medicine called TEV-48574. It's for adults who have either Crohn's disease or ulcerative colitis, specifically if their condition is considered moderate to severe. Both of these are long-term conditions that affect the gut and can cause a lot of discomfort and other symptoms.
The main aim of this study is to see how well TEV-48574 works in improving symptoms and helping people feel better. Researchers also want to understand if it's safe to use and what effects it might have on the body. To do this fairly, some participants will receive the actual medicine, while others will receive a placebo – a substance that looks exactly like the medicine but contains no active drug. This helps researchers compare the treatment's effects against doing nothing, so they can be sure any improvements are due to TEV-48574.
This is a 'Phase 2' study, which means it's an earlier stage of drug testing. Researchers are still exploring the best dose and how effective the medicine might be. The information gathered from this study will help decide if TEV-48574 shows enough promise to move on to larger studies and potentially become a widely available treatment in the future.
Key takeaways
- This study is testing a new medicine (TEV-48574) for Crohn's and ulcerative colitis.
- It's for adults with moderate to severe forms of these conditions.
- Participants will receive either the new medicine or a dummy medicine.
- The study lasts 14 weeks and involves regular clinic visits.
- The goal is to check how well the medicine works and if it's safe.
- This is an early-stage study (Phase 2).
Who may be eligible?
This study is looking for adult volunteers to take part. To be eligible, you must be 18 years old or older. There is no upper age limit mentioned.
Participants can be male or female.
The study is specifically for people who have been diagnosed with either Crohn's disease or ulcerative colitis, and their condition is currently considered moderate to severe.
- Are you 18 years old or older?
- Do you have a diagnosis of Crohn's disease?
- Do you have a diagnosis of ulcerative colitis?
- Is your condition currently considered moderate to severe?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, it will last for 14 weeks. Throughout this time, you will receive either the study medication (TEV-48574) or a placebo, given as an injection under the skin. Both the medicine and the placebo are carefully prepared to look and feel the same. Neither you nor your study doctor will know which one you are receiving – this is known as 'double-blind' and helps ensure the study results are unbiased. You will have regular visits to the clinic for check-ups. During these visits, the study team will monitor your health, ask about your symptoms (like how often you go to the toilet or if you have any bleeding), and may perform examinations, including some to look inside your bowel. They will also take blood samples to see how your body is reacting to the treatment.
Potential risks and benefits
Locations (12)
- —Slovakia
- —France
- —Austria
- —Bulgaria
- —Hungary
- —Norway
- —Czechia
- —Germany
- —Italy
- —Spain
- —Belgium
- —Poland
Common questions
What is TEV-48574?
TEV-48574 is a new medicine being tested to see if it can help adults with moderate to severe Crohn's disease or ulcerative colitis.
What does 'randomised' mean?
Randomised means that whether you get the new medicine or the dummy medicine is decided by chance, like flipping a coin. This makes sure the study is fair.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active ingredients. It helps researchers compare the real medicine's effects.
How long will the study last?
The main part of this study will last for 14 weeks.
Can I leave the study if I want to?
Yes, you are free to stop participating in the study at any time, for any reason, and it will not affect your 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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