A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
This research is looking into a new oral medicine called Icotrokinra for adults and teenagers (aged 12 and up) who have ulcerative colitis (UC). UC is a long-term condition where the lining of the large bowel becomes inflamed and develops small sores. Participants in this study have UC that is moderate to severe. The main goal is to find out if Icotrokinra is effective at treating UC symptoms, if it's safe to use, and if people find it tolerable, compared to a placebo (a dummy pill with no active medicine). This is a Phase 3 study, which means it's a large trial to confirm the medicine's benefits and safety before it can be considered for wider use.
At a glance
What is this study about?
This clinical trial is exploring a new treatment for ulcerative colitis, a condition that affects your large bowel. In ulcerative colitis, the lining of your bowel becomes inflamed and can develop small ulcers, leading to symptoms like tummy pain, urgent trips to the toilet, and sometimes blood in your poo. This study focuses on people whose ulcerative colitis is moderate to severe, meaning their symptoms are significant and impacting their daily lives.
The new medicine being tested is called Icotrokinra, and it's taken by mouth. The researchers want to understand a few key things: firstly, how effective it is at reducing the inflammation and improving symptoms compared to a placebo (a 'dummy' pill). Secondly, they're carefully checking for any side effects or problems that might come from taking it, looking at its safety. And finally, they want to see if people can comfortably take the medicine without too many bothersome effects – this is called tolerability.
Finding new and effective treatments for ulcerative colitis is really important. Existing treatments don't work for everyone, and some people experience side effects. This study aims to see if Icotrokinra could be another helpful option for patients who haven't responded well to other therapies or can't tolerate them.
Key takeaways
- This study is for adults and teenagers with moderate to severe ulcerative colitis.
- It's testing a new oral medicine called Icotrokinra against a dummy pill (placebo).
- The aim is to check how well Icotrokinra works, if it's safe, and if people can tolerate it.
- You might be eligible if other UC treatments haven't worked well or you couldn't tolerate them.
- There are specific health conditions and past surgeries that would prevent you from joining.
- You will receive close medical monitoring throughout the study.
Who may be eligible?
To join this study, you need to have a confirmed diagnosis of ulcerative colitis (UC) that was made at least 12 weeks ago. Your UC needs to be described as moderately to severely active – doctors will check this using a special score based on a camera investigation of your bowel. Teenagers aged 12 and up must weigh at least 40 kilograms (6 stone 4 pounds). If you're a female and could become pregnant, you'll need to have negative pregnancy tests and agree to further tests during the study.
An important part of who can join depends on your previous treatments. You must either not have responded well to or couldn't tolerate standard UC treatments, AND you haven't yet tried certain advanced therapies (like biologics). Or, if you have tried advanced therapies, they either didn't work initially, stopped working, or you couldn't tolerate them.
You cannot join if you have certain serious complications of UC, such as very severe inflammation known as fulminant colitis, or a very swollen bowel (toxic megacolon), or if you might need bowel surgery soon. You also can't take part if you have a stoma, a history of fistulas, or if you've had major bowel surgery recently (within the last 24 weeks) or other major surgery in the last 12 weeks. If you've had a lot of your bowel removed, or surgery that would make it hard to measure how well treatments are working, you also won't be able to participate.
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.
- I have been diagnosed with ulcerative colitis at least 12 weeks ago.
- My ulcerative colitis is currently moderately to severely active.
- If I am a teenager, I weigh at least 40 kilograms (about 6 stone 4 pounds).
- I have either tried other UC treatments that didn't work or I couldn't tolerate them.
- I do not have serious UC complications like toxic megacolon or a stoma.
- I haven't had major bowel surgery in the last 6 months or other big surgery in the last 3 months.
What does participation involve?
If you decide to take part, you'll be given either the new study medicine, Icotrokinra, or a placebo (a dummy pill) to take by mouth. You won't know which one you're receiving. You'll have regular visits to the study clinic where the research team will monitor your health, check for any side effects, and assess how your ulcerative colitis is responding to the treatment. This will involve physical examinations, blood tests, and potentially more camera investigations of your bowel. You will also be asked to report on your symptoms. The exact number of visits and the total duration of your involvement will be clearly explained by the study team, but clinical trials typically involve follow-up over several months.
Potential risks and benefits
Locations (385)
- AZ Gastro CareVerified postcodeChandler, United States· Recruiting
- Research Solutions of ArizonaVerified postcodeLitchfield Park, United States· Recruiting
- Mayo ClinicVerified postcodeScottsdale, United States· Recruiting
- Clinnova ResearchVerified postcodeAnaheim, United States· Recruiting
- Southern California Research CenterVerified postcodeCoronado, United States· Recruiting
- Om Research LLCVerified postcodeLancaster, United States· Recruiting
- TLC Clinical Research IncVerified postcodeLos Angeles, United States· Recruiting
- GastroIntestinal BioscienceVerified postcodeLos Angeles, United States· Recruiting
- Om Research LLC 2Verified postcodeOxnard, United States· Recruiting
- Clinical Applications Laboratories, IncVerified postcodeSan Diego, United States· Recruiting
- Medical Associates Research Group, Inc.Verified postcodeSan Diego, United States· Recruiting
- Peak Gastroenterology AssociatesVerified postcodeColorado Springs, United States· Recruiting
Common questions
What is ulcerative colitis?
Ulcerative colitis is a long-term condition where the lining of your large bowel (colon and rectum) becomes inflamed and develops tiny ulcers, causing symptoms like tummy pain, diarrhoea, and blood in your poo.
What is Icotrokinra?
Icotrokinra is a new medicine, taken as a pill, that is being tested to see if it can help treat moderate to severe ulcerative colitis.
What is a placebo?
A placebo is a 'dummy' pill that looks just like the study medicine but contains no active drug. It helps researchers compare the real medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving Icotrokinra or the placebo.
How long will I need to be in the study?
The study duration will be explained by the research team, but trials like this usually involve follow-up over several months to properly assess the treatment.
How to find out more
Study Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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