Phase IIa Study Evaluating AZD7798 in Crohn's Disease
This study is looking at a new medicine called AZD7798 for people in the UK aged 18-80 who have moderate to severe Crohn's disease. Half the participants will get the new medicine, and the other half will get a dummy medicine (placebo). No one will know who is getting which. The aim is to find out if AZD7798 is safe and effective in reducing Crohn's symptoms. This is an important step in developing new treatments for this condition. We're looking for individuals who haven't responded well to other treatments or who rely on steroids.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
Crohn's disease is a condition that causes inflammation in your digestive system. This can lead to symptoms like tummy pain, diarrhoea, tiredness, and weight loss. For some people, these symptoms can be difficult to manage with current treatments, or their illness might be quite severe.
This study is designed to test a new medicine called AZD7798. It's a 'Phase IIa' study, which means it's an early-stage study to see if the medicine works and is safe. The main goal is to find out if AZD7798 can help reduce the inflammation and improve symptoms in people with moderate to severe Crohn's disease.
We'll be comparing AZD7798 against a 'placebo', which is a dummy medicine that looks just like the real one but has no active ingredients. This helps scientists understand if any changes are due to the new medicine or other factors. Both you and your study doctor won't know whether you're receiving AZD7798 or the placebo, which helps make the study results as fair and accurate as possible.
النقاط الرئيسية
- This study is for adults with moderate to severe Crohn's disease.
- It's testing a new medicine, AZD7798, against a dummy medicine (placebo).
- It aims to see if AZD7798 is safe and helps improve Crohn's symptoms.
- You might be eligible if other treatments haven't worked well or if you depend on steroids.
- Both you and your doctor won't know if you're getting the active medicine or placebo.
- سيتم مراقبة صحتك عن كثب طوال فترة الدراسة.
من قد يكون مؤهلاً؟
This study is looking for adults aged between 18 and 80 years old who have been diagnosed with Crohn's disease. Your Crohn's disease needs to be active and either moderate or severe. This means it's causing significant symptoms even with current treatments.
We are particularly interested in people whose Crohn's affects their small bowel, large bowel, or both. You should also have tried other treatments (like steroids, azathioprine, or other advanced therapies) which haven't worked well enough, or you might rely on steroids to keep your symptoms under control.
There are also some reasons why you might not be able to join. For example, if you have other types of inflammatory bowel disease, very narrow or blocked parts of your bowel, or certain complications of Crohn's disease. You also can't be pregnant or breastfeeding. The study team will check all these details carefully to make sure the study is right and safe for you.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- هل عمرك بين 18 و 80 سنة؟
- Have you been diagnosed with Crohn's disease that is currently active and moderate to severe?
- Have your usual Crohn's treatments not worked well enough, or do you rely on steroids?
- Do you have Crohn's disease affecting your small bowel, large bowel, or both?
- Do you not have any other severe bowel conditions or complications that would prevent you from joining?
ماذا يتضمن المشاركة؟
If you decide to join the study, you'll be regularly seen by the study team. This will involve visits to the clinic where you might have physical examinations, blood tests, and perhaps some scans or endoscopies (where a tiny camera looks inside your gut.) These tests help us monitor your health and see how the medicine is working.
You'll be given the study medicine (either AZD7798 or the placebo) as directed by the medical team. It's really important to take the medicine exactly as prescribed. You'll also be asked about your symptoms and how you're feeling throughout the study. The total time you'd be involved in the study would depend on the study design, and the research team will explain this fully during the consent process.
المخاطر والفوائد المحتملة
Locations (149)
- موقع البحثالرمز البريدي المؤكدفينيكس، الولايات المتحدة
- موقع البحثالرمز البريدي المؤكدEscondido, United States
- موقع البحثالرمز البريدي المؤكدلا جولا، الولايات المتحدة
- موقع البحثالرمز البريدي المؤكدVictorville, United States
- موقع البحثالرمز البريدي المؤكدHamden, United States
- موقع البحثالرمز البريدي المؤكدأورلاندو، الولايات المتحدة
- موقع البحثالرمز البريدي المؤكدتامبا، الولايات المتحدة
- موقع البحثالرمز البريدي المؤكدشلالات أيداهو، الولايات المتحدة
- موقع البحثالرمز البريدي المؤكدكانساس سيتي، الولايات المتحدة
- موقع البحثالرمز البريدي المؤكدClinton Township, United States
- موقع البحثالرمز البريدي المؤكدLiberty, United States
- موقع البحثالرمز البريدي المؤكدسانت لويس، الولايات المتحدة
أسئلة شائعة
What is a 'Phase IIa' study?
It's an early-stage study that tests a new medicine on a smaller group of people to see if it's safe and if it shows promise in treating the condition.
ماذا يعني مصطلح "مزدوج التعمية"؟
It means neither you nor your study doctor will know whether you are receiving the new medicine or the dummy medicine (placebo). This helps make the study results fair.
ما هو "العلاج الوهمي"؟
A placebo is a dummy medicine that looks just like the real medicine but contains no active ingredients. It's used to compare against the new medicine.
Will I still receive my regular Crohn's treatment?
This will depend on the study protocol and your current medications. The study team will discuss all your current medicines with you before you start.
هل يمكنني مغادرة الدراسة في أي وقت؟
Yes, your participation is completely voluntary. You can choose to stop being part of the study at any time, for any reason, without affecting your medical care.
كيفية معرفة المزيد
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
نقاش
مناقشة المجتمع
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