A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
This study is for adults aged 18 to 75 with coeliac disease that doesn't improve with a gluten-free diet. It aims to see if a new medicine, amlitelimab, can help. Participants will either receive the new medicine or a dummy medicine (placebo) alongside their gluten-free diet. Some will also have planned, controlled exposure to small amounts of gluten. The study will check how the medicine affects the gut lining (using tiny samples taken from the gut), gut symptoms like tummy pain or bloating, and overall safety. The aim is to find out if amlitelimab can make a difference for people still struggling with coeliac symptoms.
במבט חטוף
על מה המחקר הזה?
You've probably heard of coeliac disease, a condition where eating gluten damages the lining of your gut. For many, following a strict gluten-free diet helps a lot. However, for some adults, even with careful dieting, symptoms like tummy pain, bloating, and diarrhoea can continue. This is sometimes called 'non-responsive coeliac disease'. This study is really important because it's looking into a new treatment called amlitelimab that might help people in this situation.
The study wants to find out two main things about amlitelimab: how well it works and if it's safe. Specifically, it will look at changes in the gut lining itself, as well as checking if common coeliac symptoms get better. Some participants will receive the active medicine, while others will get a placebo (a dummy medicine with no active ingredients). This is standard practice in medical research to fairly compare the new treatment's effects. Researchers will also be checking how the body handles the medicine and any side effects.
By taking part, you could be helping to find a new way to manage coeliac disease for those who aren't fully helped by a gluten-free diet alone. The information gathered from this study will be used to understand if amlitelimab could become a useful treatment option in the future, potentially improving the quality of life for many people.
נקודות עיקריות
- The study is for adults with coeliac disease not fully responding to a gluten-free diet.
- It tests a new medicine called amlitelimab alongside a dummy medicine (placebo).
- Participation involves regular visits and two gut examinations (gastroscopies).
- The study aims to improve gut health and reduce coeliac symptoms.
- אתה יכול לפרוש מהמחקר בכל עת.
- Findings could offer new treatment options for coeliac disease.
מי עשוי להיות זכאי?
This study is looking for adults between 18 and 75 years old who have been officially diagnosed with coeliac disease. You'll need to have a clear history of this diagnosis, confirmed by your doctor or medical records. Importantly, you should have been following a gluten-free diet for at least a year and are willing to continue doing so throughout the study. The study is for those whose coeliac disease symptoms haven't fully improved with the gluten-free diet alone. During the screening process, you'll need to show you have at least one moderate or severe gut symptom (like diarrhoea, tummy pain, bloating, or feeling sick) most days, which your doctor believes is linked to your coeliac disease.
There are some reasons why you might not be able to join. For example, if you have very severe forms of coeliac disease, such as refractory coeliac disease types 1 or 2, or other serious gut conditions like inflammatory bowel disease (Crohn's or ulcerative colitis), you wouldn't be eligible. Also, if you've had a recent serious gut problem like a perforation (a hole in the gut) or need certain immune-suppressing medicines for coeliac disease complications, you wouldn't be able to take part.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- האם אתה בין גיל 18 ל-75?
- Do you have a confirmed diagnosis of coeliac disease?
- Have you been strictly gluten-free for at least a year?
- Do you still experience moderate to severe gut symptoms (like tummy pain or bloating) most days, despite your gluten-free diet?
- Are you able to attend regular appointments and have two gut examinations (gastroscopies)?
- Do you NOT have severe forms of coeliac disease (like refractory coeliac disease type 1 or 2) or other serious gut conditions?
מה כרוך בהשתתפות?
If you decide to take part, you'll be assigned to one of six different groups, some receiving the active medication (amlitelimab) and others a placebo (dummy medicine). The medicine will be given as an injection under the skin. You'll need to continue your usual gluten-free diet throughout the study. Some groups will also experience planned, small exposures to gluten, to help researchers understand the medicine's effect when gluten is accidentally eaten.
The study involves regular visits. If you don't choose to participate in a longer-term part of the study, you'll have up to 10 visits over about 48 weeks (just under a year). This includes a check-up period after you finish taking the study medicine. If you do join the longer-term part, you could be in the study for up to 172 weeks (over 3 years) with 22 visits. During these visits, there will be various assessments, including questionnaires about your symptoms and two procedures called gastroscopies (where a tiny camera looks inside your gut, and small tissue samples are taken) to check for changes in your gut lining.
סיכונים ותועלות פוטנציאליים
Locations (118)
- One of a Kind Clinical Research Center - Scottsdale- Site Number : 8400055מיקוד מאומתסקוטסדייל, ארצות הברית
- FOMAT Medical Research - inSite Digestive Health Care - Arcadia- Site Number : 8400052מיקוד מאומתArcadia, United States
- Om Research- Site Number : 8400001מיקוד מאומתלנקסטר, ארצות הברית
- United Medical Doctors - Los Alamitos- Site Number : 8400014מיקוד מאומתלוס אלאמיטוס, ארצות הברית
- Om Research- Site Number : 8400010מיקוד מאומתאוקסנארד, ארצות הברית
- Advanced Research Institute - Denver- Site Number : 8400048מיקוד מאומתדנוור, ארצות הברית
- Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400040מיקוד מאומתמיאמי לייקס, ארצות הברית
- Center for Digestive Health- Site Number : 8400013מיקוד מאומתאורלנדו, ארצות הברית
- GCP Clinical Research- Site Number : 8400007מיקוד מאומתטמפה, ארצות הברית
- Treasure Valley Medical Research- Site Number : 8400006מיקוד מאומתבויסי, ארצות הברית
- Hutchinson Clinic- Site Number : 8400020מיקוד מאומתHutchinson, United States
- University of Kansas Medical Center- Site Number : 8400041מיקוד מאומתקנזס סיטי, ארצות הברית
שאלות נפוצות
מהו אמליטלימאב?
Amlitelimab is a new medicine being tested in this study to see if it can help adults with coeliac disease that hasn't fully responded to a gluten-free diet.
מהו פלצבו?
A placebo is a 'dummy' treatment that looks like the study medicine but doesn't contain any active ingredients. It helps researchers compare the new medicine's effects fairly.
Will I have to eat gluten?
Some groups in the study will have planned, small exposures to gluten under controlled conditions, while continuing their gluten-free diet. This helps researchers understand the medicine's effect.
כמה זמן יימשך המחקר?
The study could last up to about 48 weeks (just under a year) with 10 visits, or up to 172 weeks (over 3 years) with 22 visits if you choose to join a longer-term part.
What is a gastroscopy?
A gastroscopy is a procedure where a thin, flexible tube with a camera is passed down your throat to look at your stomach and the first part of your small intestine. Small tissue samples (biopsies) are taken from your gut lining.
כיצד לגלות עוד
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
דיון
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