A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis
This research study is testing a new drug called tulisokibart for adults aged 18 and over who have moderate to severe ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and ulcers in the large intestine. The study wants to find out if tulisokibart is safe to use and if it can help improve symptoms, such as reducing gut inflammation, bleeding, and frequent stools. Participants will either receive the new drug or a placebo (a dummy treatment) to see if there's a difference. Researchers will closely monitor participants' health, symptoms, and any side effects over 12 weeks to understand how well the treatment works.
At a glance
What is this study about?
Ulcerative colitis is a condition where the lining of your large intestine (colon and rectum) becomes inflamed and develops tiny sores, called ulcers. This can lead to symptoms like stomach pain, urgent trips to the toilet, bloody stools, and feeling very tired. Living with these symptoms can be challenging, and finding effective treatments is very important.
This study, called a Phase 2 trial, is exploring a new medicine called tulisokibart. "Phase 2" means it's an early-stage study to see if a treatment is safe and if it shows promise in treating the condition. Researchers want to understand if this new drug can help reduce the inflammation and symptoms for people with moderate to severe ulcerative colitis.
To do this, some participants will receive the new medicine, and others will receive a placebo (a look-alike medicine with no active drug) – this helps the researchers fairly compare the effects. The study will carefully check for any side effects and see how well the medicine improves symptoms like bleeding and stool frequency over a 12-week period. The aim is to find better ways to manage ulcerative colitis and improve the quality of life for those affected.
Key takeaways
- The study is testing a new medicine, tulisokibart, for moderate to severe ulcerative colitis.
- It's a Phase 2 trial, focusing on safety and how well the drug works.
- Participants will receive either the new drug or a placebo.
- The study lasts for 12 weeks of treatment, with regular check-ups.
- It aims to find better ways to manage ulcerative colitis symptoms like bleeding and stool frequency.
Who may be eligible?
This study is looking for adults aged 18 years and older. There is no upper age limit, meaning older adults are also welcome to participate.
Both men and women can take part in this research.
To be eligible, you must have been diagnosed with ulcerative colitis and your condition is currently considered moderate to severe. "Moderate to severe" means your symptoms are significantly affecting your daily life despite current treatments. Your doctor will be able to confirm if your condition meets these criteria.
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?
- Is your ulcerative colitis currently considered moderate to severe?
- Are you comfortable with regular clinic visits and possible endoscopic exams?
- Are you willing to potentially receive a placebo instead of the active drug?
What does participation involve?
If you decide to take part, you'll be involved in this study for 12 weeks of treatment. Throughout this time, you will have regular visits to the clinic so that the study team can monitor your health and progress closely. These visits will likely involve physical examinations, answering questions about your symptoms, and providing blood or stool samples.
Some assessments might involve endoscopic examinations, where a thin, flexible tube with a camera is used to look inside your colon. You will receive either the study drug, tulisokibart, or a placebo (a dummy drug) during this period. The study is "double-blind," meaning neither you nor your study doctor will know which treatment you are receiving until the study is over. There will also be a follow-up period after the 12 weeks of treatment to check on your well-being.
Potential risks and benefits
Locations (4)
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedHungary
Common questions
What is ulcerative colitis?
It's a long-term condition causing inflammation and sores (ulcers) in the lining of your large intestine (colon and rectum).
What does 'Phase 2' trial mean?
It means this is an early study to see if the new medicine, tulisokibart, is safe and shows promise in treating the condition, before larger studies begin.
What is 'tulisokibart'?
It's the name of the new experimental medicine being tested in this study for ulcerative colitis.
What is a placebo?
A placebo is a dummy treatment that looks like the real medicine but contains no active drug. It helps researchers compare the effects fairly.
How long does the study last?
The main treatment period for the study is 12 weeks, with follow-up appointments afterwards.
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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