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.
Överblick
Vad handlar denna studie om?
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.
Viktiga punkter
- 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.
- Din hälsa kommer att övervakas noggrant under hela tiden.
- Du kan sluta delta när som helst.
Vem kan vara berättigad?
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.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Är du mellan 18 och 75 år gammal?
- 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?
Vad innebär deltagande?
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.
Potentiella risker och fördelar
Locations (115)
- GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003Verifierat postnummerSun City, USA· Rekrytering
- Bristol Hospital- Site Number : 8400017Verifierat postnummerBristol, USA· Rekrytering
- Novum Research- Site Number : 8400018Verifierat postnummerClermont, United States· Rekrytering
- Clinical Research of Osceola- Site Number : 8400012Verifierat postnummerKissimmee, United States· Rekrytering
- Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002Verifierat postnummerMiami Lakes, USA· Rekrytering
- GCP Clinical Research- Site Number : 8400016Verifierat postnummerTampa, USA· Rekrytering
- GI Alliance - Glenview- Site Number : 8400005Verifierat postnummerGlenview, USA· Rekrytering
- Illinois Gastroenterology Group- Site Number : 8400004Verifierat postnummerGurnee, United States· Rekrytering
- University of Michigan Health System - Ann Arbor- Site Number : 8400010Verifierat postnummerAnn Arbor, USA· Rekrytering
- Icahn School of Medicine at Mount Sinai- Site Number : 8400001Verifierat postnummerNew York, USA· Rekrytering
- Queens Village Primary Medical Center- Site Number : 8400011Verifierat postnummerQueens Village, United States· Rekrytering
- NexGen Research- Site Number : 8400020Verifierat postnummerLima, United States· Rekrytering
Vanliga frågor
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.
Vad är en 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.
Hur länge kommer jag att vara med i studien?
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.
Kan jag sluta delta i studien när som helst?
Yes, you are free to leave the study at any point, for any reason, without it affecting your medical care.
Hur du får reda på mer
Trial Transparency email recommended (Toll free for US & Canada)
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
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