A Study Evaluating TRIV-509 in Atopic Dermatitis
This research study is looking into a new medicine called TRIV-509 for people aged 18 to 75 who have moderate to severe eczema, also known as atopic dermatitis. The main goals are to find out if TRIV-509 can effectively treat eczema and if it's safe for patients to use. Participants will receive either TRIV-509 or a 'dummy' treatment (placebo) for 16 weeks. Afterwards, they will switch and receive the other treatment for another 16 weeks. This helps researchers compare the effects of the new medicine to the placebo directly in each person. The study will last for up to 57 weeks for each participant, including an initial check-up period.
במבט חטוף
על מה המחקר הזה?
This study is a medical research project focused on a new potential treatment for eczema, specifically moderate to severe atopic dermatitis, in adults. Atopic dermatitis is a common skin condition that causes dry, itchy, and inflamed skin. The new medicine being tested is called TRIV-509.
The main purpose of this study is to understand two important things: first, if TRIV-509 can help reduce the symptoms of moderate to severe eczema; and second, to check if the medicine is safe and doesn't cause too many side effects. By carefully studying the effects of TRIV-509, doctors hope to find better ways to manage this challenging skin condition.
In this type of study, some people will receive the new medicine, TRIV-509, while others will receive a 'placebo.' A placebo looks just like the real medicine but contains no active ingredients. This comparison is very important because it helps researchers know if any changes people experience are truly due to the new medicine or if they might have happened anyway. After a set period, participants will switch treatments, so everyone gets a chance to take both the active medicine and the placebo at different times.
נקודות עיקריות
- Testing a new medicine (TRIV-509) for moderate to severe eczema in adults.
- Aims to check if it works and is safe.
- Participants will try both the new medicine and a dummy treatment (placebo) over time.
- The study lasts up to 57 weeks.
- Open to adults aged 18-75 with active eczema.
- Close medical monitoring throughout the study.
מי עשוי להיות זכאי?
To be part of this study, you need to be an adult between 18 and 75 years old. You must have eczema (atopic dermatitis) that is considered moderate to severe, meaning it's causing significant symptoms and is active at the time of the study.
There are certain reasons why you might not be able to join. For example, if you have other serious or uncontrolled health problems. Also, if you've recently used certain treatments for your eczema, such as strong creams, light therapy, or specific medicines that affect your immune system, you might need to wait a certain period before you can participate. This 'waiting period' is to make sure that any effects seen in the study are from TRIV-509 and not from previous treatments.
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 moderate to severe eczema (atopic dermatitis) that is active right now?
- Do you have any other serious or uncontrolled health conditions?
- Have you recently used strong eczema treatments like special creams, light therapy, or certain immune-modifying medicines?
מה כרוך בהשתתפות?
If you decide to take part in this study, the total time commitment will be up to 57 weeks. This includes an initial check-up period that could last up to 30 days to make sure you meet all the requirements. During the main part of the study, you will receive either TRIV-509 or a dummy treatment (placebo) for 16 weeks, taking 4 doses of that treatment. Then, you will switch to the other treatment (the one you didn't get first) for another 16 weeks, also taking 4 doses. You will have regular visits to the clinic for assessments, which will likely include physical examinations, blood tests, and discussions about how you're feeling and how your eczema is changing. All study-related medication and assessments will be provided.
סיכונים ותועלות פוטנציאליים
Locations (32)
- Triveni Bio Site #11מיקוד מאומתפאונטיין ואלי, ארצות הברית
- Triveni Bio Site #4מיקוד מאומתסן דייגו, ארצות הברית
- Triveni Bio Site #3מיקוד מאומתמיאמי, ארצות הברית
- Triveni Bio Site #6מיקוד מאומתאינדיאנפוליס, ארצות הברית
- Triveni Bio Site #10מיקוד מאומתSouth Bend, United States
- Triveni Bio Site #1מיקוד מאומתCamp Hill, United States
- Triveni Bio Site #16מיקוד מאומתBellaire, United States
- Triveni Bio Site #5מיקוד מאומתדאלאס, ארצות הברית
- Triveni Bio Site #8מיקוד מאומתSpokane, United States
- Triveni Bio Site #38מיקוד מאומתPleven, Bulgaria
- Triveni Bio Site #39מיקוד מאומתSofia, Bulgaria
- Triveni Bio Site #13מיקוד מאומתAjax, Canada
שאלות נפוצות
What is atopic dermatitis?
Atopic dermatitis is a common type of eczema that causes dry, itchy, and irritated skin. It often starts in childhood but can affect adults too.
What does 'moderate to severe' atopic dermatitis mean?
This means your eczema is causing significant symptoms that affect your daily life, and it's active when you join the study.
מהו פלצבו?
A placebo is a 'dummy' treatment that looks just like the real medicine but doesn't contain any active ingredients. It helps researchers compare the new medicine's effects.
האם אדע אם אני מקבל את התרופה האמיתית או את הפלצבו?
No, neither you nor the study doctors will know who is getting which treatment during the main part of the study. This is called 'blinding' and helps keep the study fair.
כמה זמן אהיה במחקר?
Your total time in the study will be up to 57 weeks, including an initial check-up period of up to 30 days.
כיצד לגלות עוד
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
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