A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
This research study is testing a new medication, SAR441566, for adults aged 18 to 75 who have moderate to severe ulcerative colitis. The main goal is to find out if this medication can help reduce symptoms and lead to remission, which means your symptoms greatly improve or disappear. Scientists also want to check if the medication is safe to use. Some participants will receive the active medication, while others will get a placebo (a dummy drug with no active ingredients). This helps researchers fairly compare how well the new medication works. The study will last around 59 weeks, with medication being given for up to 52 weeks.
Em resumo
Sobre o que é este estudo?
If you have ulcerative colitis, you know it can be a challenging condition to live with. Researchers are continuously working to find new and better treatments to help people feel better and improve their quality of life. This particular study is focusing on a new investigational medication called SAR441566.
The main purpose of this study is to see how well SAR441566 works in adults who have moderate to severe ulcerative colitis, especially if their current treatments haven't been effective enough. They also want to understand if it's a safe medication to use. To do this, some participants will receive the new medication, while others will receive a 'placebo', which looks identical but doesn't contain any active drug. This is a standard way to test new medicines fairly, making sure that any improvements seen are truly due to the study medication.
The study involves different doses of SAR441566 to figure out which dose might be most effective. After starting the medication, there will be a period to see if symptoms improve (called the 'induction period'), followed by a longer period to see if those improvements can be maintained. If you decide to take part, your health will be carefully monitored throughout the study to make sure it's safe for you and to track how your ulcerative colitis responds to the treatment.
Pontos principais
- This study is for adults (18-75) with moderate to severe ulcerative colitis.
- It tests a new medication, SAR441566, for its safety and effectiveness.
- Some participants will receive the active drug, others a placebo.
- The study involves regular clinic visits over about a year, possibly longer.
- Your health will be closely monitored throughout.
- Você pode parar de participar a qualquer momento.
Quem pode ser elegível?
This study is looking for men and women between the ages of 18 and 75 who have been diagnosed with ulcerative colitis for at least three months. Importantly, your ulcerative colitis needs to be considered 'active' and 'moderate to severe' by the study doctors through specific checks, including a camera test (endoscopy).
You might be suitable if your current treatments for ulcerative colitis haven't worked well enough, or if you couldn't tolerate them. This includes people who haven’t tried newer, advanced treatments yet, as well as those who have tried one or more advanced treatments (like biologics or certain small molecule drugs) and they haven't been effective enough or caused you problems.
However, some conditions would mean you couldn't join. For example, if you have other bowel conditions like Crohn's disease, or if you have serious complications of ulcerative colitis such as a severely swollen colon (toxic megacolon). The study team will review all your medical information carefully to see if this study is right for you.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Você tem entre 18 e 75 anos?
- Have you been diagnosed with ulcerative colitis for at least 3 months?
- Are your ulcerative colitis symptoms currently active and considered moderate to severe?
- Have your current or past ulcerative colitis treatments not worked well enough, or caused problems?
- Do you NOT have other serious bowel conditions like Crohn's disease or complications like toxic megacolon?
O que envolve a participação?
If you decide to join this study, your journey will involve a few different stages. First, there's a 'screening period' lasting up to 28 days where tests will be done to confirm you meet all the study requirements. After screening, the main treatment period will last about 52 weeks. During this time, you'll receive either the study medication SAR441566 or a placebo (dummy drug).
This 52-week period is split into an initial 12 weeks to see how your body responds, followed by a 40-week period to maintain any improvements. Throughout this main treatment phase, you'll have about 12 visits to the clinic. After your treatment finishes, there will be a 2-week follow-up to check on your health.
Some participants who complete the main treatment period might also have the option to enter an 'Open Label' period for up to 40 additional weeks. In an open-label study, everyone knows they are receiving the active medication. If you join this part, you would have about 8 extra clinic visits. In total, the study could last up to 59 weeks.
Riscos e benefícios potenciais
Locations (115)
- GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003Código postal verificadoSun City, Estados Unidos· Recrutamento
- Bristol Hospital- Site Number : 8400017Código postal verificadoBristol, United States· Recrutamento
- Novum Research- Site Number : 8400018Código postal verificadoClermont, United States· Recrutamento
- Clinical Research of Osceola- Site Number : 8400012Código postal verificadoKissimmee, United States· Recrutamento
- Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002Código postal verificadoMiami Lakes, United States· Recrutamento
- GCP Clinical Research- Site Number : 8400016Código postal verificadoTampa, Estados Unidos· Recrutamento
- GI Alliance - Glenview- Site Number : 8400005Código postal verificadoGlenview, United States· Recrutamento
- Illinois Gastroenterology Group- Site Number : 8400004Código postal verificadoGurnee, United States· Recrutamento
- University of Michigan Health System - Ann Arbor- Site Number : 8400010Código postal verificadoAnn Arbor, Estados Unidos· Recrutamento
- Icahn School of Medicine at Mount Sinai- Site Number : 8400001Código postal verificadoNova Iorque, Estados Unidos· Recrutamento
- Queens Village Primary Medical Center- Site Number : 8400011Código postal verificadoQueens Village, United States· Recrutamento
- NexGen Research- Site Number : 8400020Código postal verificadoLima, United States· Recrutamento
Perguntas frequentes
What is SAR441566?
SAR441566 is a new medication being tested in this study to see if it can help people with ulcerative colitis. It's currently an investigational drug, meaning it's not yet approved for general use.
O que é um placebo?
A placebo is a 'dummy drug' that looks exactly like the study medication but doesn't contain any active ingredients. It's used to fairly compare the new medication's effects against no active treatment.
Will I know if I'm getting the real medication or the placebo?
For most of the study (the 'double-blind' period), neither you nor your study doctor will know if you're receiving SAR441566 or the placebo. This helps ensure unbiased results.
Quanto tempo estarei no estudo?
The study could last up to 59 weeks in total, including screening, treatment for up to 52 weeks, and follow-up. Some participants might have the option to join an additional open-label period.
Posso parar de participar do estudo a qualquer momento?
Sim, você é livre para deixar o estudo a qualquer momento, por qualquer motivo, sem que isso afete seu atendimento médico.
Como saber mais
Trial Transparency email recommended (Toll free for US & Canada)
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
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