A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
This study is testing a new medicine, mirikizumab, for children and teenagers aged 2 to 17 years who have Crohn's disease. Researchers want to see if mirikizumab can help manage the condition when other treatments haven't worked well enough. They will also check its safety, how well bodies cope with it, and how much of the medicine gets into the body. Participants will be carefully screened and then randomly assigned to receive either mirikizumab or another treatment. The study will last about 74 weeks and involve regular check-ups, helping doctors understand if this new medicine could be a good option for young people with Crohn's.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
Crohn's disease is a long-term condition where parts of the digestive system become inflamed. This can cause various symptoms like tummy pain, diarrhoea, and weight loss. For many young people with Crohn's, finding a treatment that works well and has manageable side effects can be a challenge. That's why researchers are studying new medicines like mirikizumab.
This particular study, officially called A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease, aims to understand if mirikizumab is a safe and effective option for children and teenagers with Crohn's disease. They are specifically looking at young people whose Crohn's hasn't responded well to other treatments they've tried. The study will carefully check how well the medicine works to reduce symptoms, how safe it is, and how the body handles the medicine.
By taking part, children and their families can help doctors learn more about mirikizumab. This research is important because it could lead to new ways to help young people with Crohn's disease feel better and lead more comfortable lives, especially if their current treatments aren't working as well as hoped.
النقاط الرئيسية
- Tests a new medicine (mirikizumab) for children and teenagers with Crohn's disease.
- Aims to help those whose Crohn's hasn't responded well to other treatments.
- Studies the medicine's safety, effectiveness, and how the body uses it.
- Lasts about 74 weeks with up to 19 clinic visits.
- المشاركة طوعية، ويمكنك الانسحاب في أي وقت.
من قد يكون مؤهلاً؟
To be considered for this study, your child must have been diagnosed with Crohn's disease, including specific types like active colitis or ileocolitis. Their Crohn's disease must also be considered moderately to severely active when they join the study, as shown by certain medical scores and an endoscopy (a procedure to look inside the digestive system) within one month of starting the medicine.
It's also important that your child has already tried and not responded well to, or couldn't tolerate, at least one other treatment for Crohn's disease. This could include medicines like immunomodulators, steroids, certain biologic therapies, or JAK inhibitors.
However, your child cannot join the study if they have certain complications of Crohn's, such as narrowings in the bowel that cause problems, or if they've recently had surgery on their bowel or tummy. They also cannot have any abscesses (pockets of infection) at the time of screening. The study is open to both boys and girls aged between 2 and 17 years.
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.
- Is your child aged between 2 and 17 years?
- Does your child have a confirmed diagnosis of Crohn's disease?
- Is your child's Crohn's disease currently moderately to severely active?
- Has your child tried at least one other Crohn's medicine that didn't work well or caused problems?
- Does your child NOT have complications like bowel blockages or abscesses?
- Has your child NOT had recent bowel surgery within the last 6 months?
ماذا يتضمن المشاركة؟
If your child takes part in this study, they would be carefully checked to make sure they are suitable. Then, they would be randomly assigned to receive either mirikizumab or another treatment. This is like flipping a coin to decide, making sure the comparison between the treatments is fair.
The study starts with a 12-week 'induction period' where the medicine aims to bring symptoms under control. After this, there's a 'maintenance period' lasting until week 52, where the medicine helps keep symptoms settled. Finally, there's a safety follow-up period for up to 16 weeks to ensure everything is okay. In total, the study will last about 74 weeks (around 1 year and 5 months) and could involve up to 19 visits to the clinic for check-ups and assessments. These visits will help the doctors monitor your child's health and how the medicine is working.
المخاطر والفوائد المحتملة
المواقع (81)
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أسئلة شائعة
What exactly is Crohn's disease?
Crohn's disease is a lifelong condition that causes parts of your digestive system to become inflamed, leading to symptoms like tummy pain, diarrhoea, and tiredness.
ما هو الميريكيزوماب؟
Mirikizumab is a new medicine being tested to see if it can help reduce inflammation and symptoms in children and teenagers with Crohn's disease.
كم ستستغرق مدة الدراسة؟
The study will last for about 74 weeks (around 1 year and 5 months), including treatment and follow-up periods.
Will my child definitely receive mirikizumab?
Not necessarily. Participants will be randomly assigned to either receive mirikizumab or another intervention, like drawing lots, to ensure a fair comparison.
Can we stop participating at any time?
Yes, you have the right to withdraw your child from the study at any time, for any reason, without affecting their future medical care.
كيفية معرفة المزيد
أسئلة التجارب أو أسئلة المشاركة: 1-877-CTLILLY (1-877-285-4559) أو
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
هل أنت مهتم بالمشاركة؟
نقاش
مناقشة المجتمع
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