A randomized, double-blind, multicenter phase 3 study in patients with moderately to severely active ulcerative colitis (UC) to compare the efficacy, safety and immunogenicity of PB016 and Entyvio® for the induction and maintenance of clinical response and remission. (UCESIVE)
This research study is for adults in the UK who have ulcerative colitis that isn't well controlled. It's a 'Phase 3' study, which means it's a key step in testing a new medicine called PB016. The study will compare PB016 with an existing treatment called Entyvio® to see how well they help improve symptoms like rectal bleeding and how safe they are. Doctors want to find out if the new medicine can lead to clinical response and long-term remission, meaning your symptoms get much better and stay better. This type of research helps doctors find new and better ways to treat ulcerative colitis.
At a glance
What is this study about?
This study is looking into a condition called ulcerative colitis, which is a long-term problem where your large intestine (colon) becomes inflamed and develops tiny ulcers. This can cause symptoms like tummy pain, bloody stools, and needing to go to the toilet urgently. If you have moderate to severe ulcerative colitis, it means your symptoms are quite noticeable and can really affect your daily life.
Doctors are testing a new medicine, called PB016, and comparing it to a treatment that's already used, called Entyvio®. They want to see if PB016 is as good as, or even better than, Entyvio® at helping people feel better and reducing their symptoms. They're also checking how safe PB016 is and if your body reacts to it in any unexpected ways. This is a "Phase 3" study, which means it's one of the final and most important steps before a new medicine can be considered for wider use.
The main goal is to find out if PB016 can lead to a 'clinical response' – meaning your symptoms significantly improve – and ultimately, 'clinical remission', where your symptoms nearly or completely disappear. They'll be checking this at different times over a year. The results of this study will help us understand if PB016 could become another helpful option for people living with ulcerative colitis.
Key takeaways
- This study evaluates a new treatment for moderate to severe ulcerative colitis.
- It compares a new medicine (PB016) to an established one (Entyvio®).
- The main goals are to assess how well the treatments work and their safety.
- Participation involves regular clinic visits and receiving study medication via infusion.
- You will be randomly assigned to one of the two treatments, and it will be 'blinded'.
Who may be eligible?
This study is looking for adults aged 18 or older who have been diagnosed with ulcerative colitis. Your ulcerative colitis should be considered 'moderately to severely active', meaning your symptoms are currently causing you significant problems.
Both men and women can take part in this research. The study will need to check your medical history to make sure there are no other health conditions or medicines you're taking that would prevent you from safely participating.
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 ulcerative colitis?
- Are your ulcerative colitis symptoms currently considered moderate to severe?
- Are you able to attend regular clinic appointments for about a year?
What does participation involve?
If you decide to join this study, you might receive either the new medicine (PB016) or the existing one (Entyvio®). This will be decided randomly, like flipping a coin, and neither you nor your study doctor will know which one you're getting — this is called 'double-blind'. You will receive the study medicine as an infusion, which means it's given directly into your vein.
You'll have regular visits to the clinic for assessments over about a year. These visits will involve checks on your symptoms, physical exams, blood tests, and sometimes other tests to see how your condition is responding to the treatment. This will help the study doctors understand how well the medicine is working and if there are any side effects. After the main part of the study, there will also be follow-up checks. The total duration of your participation will be explained in detail by the study team.
Potential risks and benefits
Locations (7)
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedRomania
- —UnverifiedHungary
- —UnverifiedSlovakia
- —UnverifiedLatvia
- —UnverifiedBulgaria
Common questions
What is ulcerative colitis?
Ulcerative colitis is a long-term condition where the large intestine (colon) becomes inflamed and develops small sores or ulcers, causing symptoms like abdominal pain and bloody stools.
What does 'Phase 3 study' mean?
A Phase 3 study is a major and final step in medical research. It tests a new treatment on a larger group of people to confirm its effectiveness and safety compared to existing treatments.
What is Entyvio®?
Entyvio® is a medicine already available and approved for treating ulcerative colitis. This study is comparing the new medicine (PB016) against it.
Will I know which treatment I'm receiving?
No, this is a 'double-blind' study, meaning neither you nor your doctor will know if you're getting the new medicine (PB016) or Entyvio® until the study is over. This helps make the study results fair.
How long will I be in the study?
The study will involve regular visits and check-ups over approximately one year, plus potential follow-up checks after that.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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