LY4268989 chez les adultes atteints de colite ulcéreuse modérément à sévèrement active
This research study is investigating a new oral medication, LY4268989, for adults who have ulcerative colitis (UC) that is active and ranges from moderate to severe. Ulcerative colitis is a long-term condition that causes inflammation in the large bowel. The main goal of this study is to check if LY4268989 is safe to use and if it works better than a placebo (a dummy pill with no active medicine) in reducing UC symptoms and improving a person's health. Participants will take the study medicine or placebo by mouth. The study will last for about 108 weeks, which is just over two years, plus a screening period to see if you can take part.
En un coup d'œil
De quoi parle cette étude ?
This study is focused on finding new and better ways to treat ulcerative colitis (UC). UC is a type of inflammatory bowel disease where the lining of your large intestine (colon and rectum) becomes inflamed and develops tiny ulcers. This can cause symptoms like tummy pain, diarrhoea, and blood in your poo. When UC is active, it means your symptoms are flaring up and can range from moderate to severe.
The researchers want to test a new medicine, LY4268989, to see if it can safely and effectively help people with moderately to severely active UC. They will compare it to a placebo, which looks just like the study medicine but doesn't contain any active drug. This comparison helps scientists understand if the new medicine is genuinely having an effect.
The findings from this type of study (called a Phase 2 trial) are very important. They help determine if a new medicine shows enough promise to move on to larger studies and potentially become available as a treatment option in the future. Participating in a study like this helps advance our understanding of UC and could lead to new treatments for others.
Points clés
- This study is testing a new oral medicine (LY4268989) for adults with active moderate to severe ulcerative colitis.
- It aims to check the safety and effectiveness of the new medicine compared to a placebo (dummy pill).
- Participation involves taking pills and regular check-ups over about two years.
- You might receive the new medicine or a placebo; neither you nor your doctor will know which.
- The study is for people whose current UC treatments are not working well or who had problems with them.
- You can leave the study at any time without impacting your regular medical care.
Qui peut être éligible ?
To join this study, you generally need to be an adult between 18 and 80 years old and have had a confirmed diagnosis of ulcerative colitis (UC) for at least three months. Your UC symptoms should be active and classed as moderate to severe by your doctor, confirmed by a scope examination. Your UC must also affect parts of your bowel beyond just the rectum.
It's important that your current UC treatment isn't working as well as it should be, or you've had problems with previous treatments like corticosteroids, biologics (like infliximab or adalimumab), or other advanced therapies. If you've had a colonoscopy recently, or regularly as advised, to check for any changes in your bowel, that's also something they'll look at.
There are also some reasons why you might not be able to join. For example, if you have Crohn's disease instead of UC, or certain other serious bowel conditions. You also can't have had cancer in the last five years, or be scheduled for bowel surgery. They will also check if you have certain infections or other serious health problems. It's best to discuss all your medical history with the study team.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- Avez-vous entre 18 et 80 ans ?
- Do you have a confirmed diagnosis of ulcerative colitis (UC)?
- Is your UC currently active and considered moderate to severe?
- Have your previous UC treatments not worked well enough, or caused problems?
- Have you had a recent colonoscopy or follow guidelines for checks?
- Do you not have Crohn's disease or certain other serious bowel conditions?
En quoi consiste la participation ?
If you decide to join this study, it will involve several visits to a clinic over a period of about 108 weeks, which is roughly two years. First, there will be a screening stage to see if you meet all the requirements. If you do, you'll start taking either the study medicine (LY4268989) or a placebo, both given as pills you swallow. You won't know which one you are taking, and neither will your study doctor, as this helps make the results fair.
Throughout the study, you'll have regular check-ups, which will likely include physical exams, blood tests, and possibly follow-up colonoscopies to monitor your UC and how you're responding to the treatment. The research team will explain all the tests and procedures to you in detail. After the main treatment period, there will be follow-up appointments to ensure your well-being. You can withdraw from the study at any time if you change your mind.
Risques et avantages potentiels
Locations (253)
- Valleywise Health Medical CenterCode postal vérifiéPhoenix, États-Unis· Pas encore en recrutement
- One of a Kind Clinical Research CenterCode postal vérifiéScottsdale, États-Unis· Pas encore en recrutement
- Clinnova ResearchCode postal vérifiéAnaheim, United States· Recrutement
- GMC Clinical ResearchCode postal vérifiéFolsom, United States· Recrutement
- Om Research LLCCode postal vérifiéTemple City, United States· Recrutement
- Om Research LLCCode postal vérifiéVictorville, United States· Recrutement
- Peak Gastroenterology AssociatesCode postal vérifiéColorado Springs, United States· Recrutement
- Advanced Research Institute - DenverCode postal vérifiéDenver, United States· Suspended
- Rocky Mountain Gastroenterology Associates - LakewoodCode postal vérifiéLakewood, United States· Recrutement
- Medical Research Center of ConnecticutCode postal vérifiéHamden, United States· Pas encore en recrutement
- K2 Medical Research - Daytona BeachCode postal vérifiéDaytona Beach, United States· Recrutement
- Clinical Research of OsceolaCode postal vérifiéKissimmee, United States· Recrutement
Questions fréquentes
What is ulcerative colitis (UC)?
Ulcerative colitis is a long-term condition that causes inflammation and sores (ulcers) in the lining of your large intestine (colon and rectum).
What does 'moderately to severely active' mean for UC?
This means your UC symptoms are currently flaring up and are affecting your daily life, and a doctor has confirmed the inflammation is moderate or severe, often through a colonoscopy.
Qu'est-ce qu'un placebo ?
A placebo is a 'dummy pill' that looks exactly like the study medicine but contains no active drug. It's used to fairly compare the new medicine's effects.
Combien de temps vais-je participer à l'étude ?
The study itself will last for approximately 108 weeks, which is about two years, not including the first screening period to check if you can join.
Puis-je arrêter de participer à l'étude si je le souhaite ?
Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your current or future medical care.
Comment en savoir plus
Questions sur les essais ou questions de participation : 1-877-CTLILLY (1-877-285-4559) ou
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Intéressé à participer ?
Discussion
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