A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
This research study is looking into a new medicine, MK-8690, for adults aged 18 to 75 who have ulcerative colitis that is moderate to severe. Ulcerative colitis is a long-term condition affecting the large bowel. The main goal is to find out if MK-8690 is effective and safe compared to a placebo (a treatment with no active medicine) in helping people achieve clinical remission. This means seeing if symptoms improve significantly and the bowel shows signs of healing after 12 weeks. If you have been struggling with your current treatments or have been diagnosed with ulcerative colitis for at least three months, you might be suitable for this study.
At a glance
What is this study about?
This research study is focused on people who have ulcerative colitis, a condition that causes inflammation and ulcers in the large bowel. If your ulcerative colitis is considered 'moderately to severely active,' it means you're likely experiencing significant symptoms like frequent diarrhoea, tummy pain, and possibly blood in your poo. The study aims to test a new medicine, MK-8690, to see if it can help improve these symptoms and lead to what doctors call 'clinical remission.'
Clinical remission means your symptoms are much better, and there are signs that the inflammation in your bowel is healing. We want to compare MK-8690 against a 'placebo,' which looks just like the real medicine but contains no active ingredients. This comparison helps us understand if any improvements are genuinely due to MK-8690 or if they might happen anyway.
The overall goal is to find new and more effective treatments for ulcerative colitis. By taking part, you could contribute to medical knowledge that might help many other people living with this condition in the future.
Key takeaways
- This study is for adults with moderate to severe ulcerative colitis.
- It's testing a new medicine (MK-8690) against a dummy medicine (placebo).
- The main aim is to see if MK-8690 helps people achieve remission.
- Participation involves regular clinic visits and health checks.
- You won't know if you're getting the active medicine or placebo.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you need to be an adult between 18 and 75 years old and have been diagnosed with ulcerative colitis for at least three months. Your ulcerative colitis should currently be active, meaning you're experiencing symptoms that are moderate to severe. It's also important that you weigh at least 40 kg (about 6 stone 4 pounds).
Doctors will also look at your past treatments. You might be eligible if your previous treatments for ulcerative colitis haven't worked well, stopped working, or if you couldn't tolerate them because of side effects. You could also be considered if you rely on certain steroid medications for your condition.
However, there are some reasons why you wouldn't be able to join. For example, if you have Crohn's disease instead of ulcerative colitis, or if your ulcerative colitis is very severe (like fulminant colitis) or only affects the very end of your bowel (rectum). If you have other serious health conditions, certain infections like hepatitis B, C, or HIV, or a history of cancer within the last five years (except for certain treated skin cancers), you might not be able to participate. Also, if you've had major bowel surgery or plan to have one soon, you wouldn't be eligible.
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 between 18 and 75 years old?
- Do you have ulcerative colitis that is currently moderate to severe?
- Have you had ulcerative colitis for at least 3 months?
- Have your current or past ulcerative colitis treatments not worked well, stopped working, or caused bad side effects?
- Do you NOT have Crohn's disease or other types of colitis?
- Are you NOT currently dealing with a serious infection like hepatitis B, C, or HIV?
What does participation involve?
If you decide to take part in this study, you will be given either the new medicine, MK-8690, or a placebo (a dummy medicine). You won't know which one you are taking. You will have regular visits to the clinic where doctors and nurses will check your health, assess your symptoms, and take blood samples. These visits will help the research team monitor how you are responding to the treatment and ensure your safety. There will also be follow-up checks after your main treatment period. The total time you would be involved in the study is not specified in detail here, but these types of studies typically involve several months of regular checks and medication.
Potential risks and benefits
Locations (28)
- Clinnova Research ( Site 1042)Verified postcodeAnaheim, United States· Recruiting
- Southern California Research Center ( Site 1044)Verified postcodeCoronado, United States· Recruiting
- Peak Gastroenterology Associates ( Site 1052)Verified postcodeColorado Springs, United States· Recruiting
- South Denver Gastroenterology, PC ( Site 1068)Verified postcodeEnglewood, United States· Recruiting
- Nature Coast Clinical Research ( Site 1045)Verified postcodeInverness, United States· Recruiting
- Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)Verified postcodeMiami, United States· Recruiting
- Gastroenterology Associates of Central Georgia ( Site 1060)Verified postcodeMacon, United States· Recruiting
- University of Kansas Medical Center ( Site 1077)Verified postcodeKansas City, United States· Recruiting
- Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 1073)Verified postcodeNew Orleans, United States· Recruiting
- BVL Research - Kansas ( Site 1054)Verified postcodeLiberty, United States· Recruiting
- Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellín ( Site 1163)Verified postcodeMedellín, Colombia· Recruiting
- Clinica de la Costa S.A.S. ( Site 1161)Verified postcodeBarranquilla, Colombia· Recruiting
Common questions
What is ulcerative colitis?
Ulcerative colitis is a long-term condition where the lining of the large bowel (colon and rectum) becomes inflamed and develops tiny ulcers, causing symptoms like tummy pain and bloody diarrhoea.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the study medicine but contains no active ingredients. It helps researchers see if the real medicine is truly effective.
Will I know if I'm getting the real medicine or the placebo?
No, during the study, neither you nor your doctors will know whether you are receiving MK-8690 or the placebo. This helps make the study results fair and accurate.
How long does the study last?
The main part of the study involves receiving treatment and being monitored for 12 weeks. There will likely be follow-up visits after this period.
Can I leave the study at any time?
Yes, your participation is completely voluntary. You can choose to leave the study at any point, and it will not affect your future medical care.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.