A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis
This research study is looking at a new medicine called KT-621 for people aged 12 to 75 who have moderate to severe atopic dermatitis (a common type of eczema). The main goals are to find out how well KT-621 works to clear up eczema, if it's safe to use, and how it affects the body. For the first 16 weeks, some participants will receive KT-621 and others will get a placebo (a dummy medicine), and neither you nor your doctor will know which you are receiving. After this, everyone will have the chance to receive KT-621 for a longer period. This will help us understand if KT-621 could be a helpful new treatment option for eczema.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
Atopic dermatitis, often called eczema, is a common skin condition that causes red, itchy, and inflamed patches on the skin. It can be uncomfortable and sometimes painful. When current treatments aren't enough, doctors and researchers look for new ways to help manage these symptoms.
This study is investigating a new medicine called KT-621. We want to see if this medicine can effectively reduce the itching, redness, and overall severity of eczema for people who have moderate to severe forms of the condition. We'll also be carefully checking for any side effects and learning how the medicine works inside the body.
This research is important because it could lead to a new treatment option for people living with eczema. Finding more effective and safer treatments can significantly improve the quality of life for many individuals affected by this condition.
النقاط الرئيسية
- This study tests a new medicine (KT-621) for moderate to severe eczema.
- It's for adults and teenagers (12-75 years old) whose current treatments aren't enough.
- The study aims to check if KT-621 is safe and effective by comparing it to a dummy pill.
- Participation involves regular clinic visits, taking the medicine by mouth, and using an e-diary.
- You'll be closely monitored by doctors and can leave the study at any time.
- It could lead to a new treatment option for people with eczema.
من قد يكون مؤهلاً؟
To join this study, you need to be between 12 and 75 years old. You should have had eczema for at least three years if you're an adult, or at least one year if you're under 18. Your eczema needs to be moderate to severe, covering at least 10% of your body, and causing significant itchiness.
It's important that your current eczema treatment, such as creams, hasn't been working well enough for at least six months, or you haven't been able to use them for other reasons. You'll also need to be using moisturiser regularly before and during the study.
You wouldn't be able to join if your eczema is getting rapidly better or worse, or if you have other skin conditions that might make it hard to tell if the new medicine is working. People with other serious health problems affecting major body systems could also be excluded.
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.
- Are you between 12 and 75 years old?
- Have you had moderate to severe eczema for at least a year (if under 18) or three years (if 18 or older)?
- Do your current eczema treatments not work well enough for you?
- Do you use moisturiser regularly on your skin?
- Is your eczema causing significant itchiness?
- Do you not have other serious skin conditions (like psoriasis) that could be confused with your eczema?
ماذا يتضمن المشاركة؟
If you decide to take part in this study, you would first go through a screening process to make sure you meet all the requirements. If you qualify, you'd be in the study for a total of about 68 weeks. The first 16 weeks involve regular visits to the clinic, where you might receive either the study medicine (KT-621) or a dummy medicine (placebo). Neither you nor the study team will know which you are receiving during this period. After these initial 16 weeks, all eligible participants will have the opportunity to take KT-621 for another 52 weeks.
During your visits, you'll have check-ups, blood tests, and we'll ask you questions about your eczema and how you're feeling. You'll also be asked to keep a record of your symptoms and how itchy you are using an electronic diary. All participants will take the study medicine by mouth, and you'll need to follow specific instructions on how and when to take it. There will be planned follow-up appointments and assessments throughout the study timeline.
المخاطر والفوائد المحتملة
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أسئلة شائعة
What is KT-621?
KT-621 is a new, investigational medicine that is being tested to see if it can help improve the symptoms of moderate to severe eczema.
What is atopic dermatitis (eczema)?
Atopic dermatitis is a long-lasting skin condition that causes patches of dry, itchy, and inflamed skin. It's often called eczema.
ماذا يعني "مزدوج التعمية، خاضع للتحكم بالدواء الوهمي"؟
It means for the first part of the study, some people will get KT-621 and some will get a dummy pill (placebo). Neither you nor your doctor will know which you are receiving, which helps us fairly assess the medicine's effects.
كم ستستغرق الدراسة إذا انضممت؟
If you meet the requirements and join, you'll be involved in the study for around 68 weeks in total.
هل يمكنني التوقف عن المشاركة في الدراسة في أي وقت؟
Yes, you can choose to leave the study at any point without it affecting your medical care.
كيفية معرفة المزيد
Kymera Medical Director
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
هل أنت مهتم بالمشاركة؟
نقاش
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