A study of JNJ-95475939 in the treatment of participants with moderate to severe atopic dermatitis
This study is looking into a new medicine called JNJ-95475939 for people with moderate to severe eczema, also known as atopic dermatitis. Eczema causes itchy, dry, and red skin. The new medicine aims to calm down the body's overactive immune response that causes these symptoms. Researchers want to compare this new drug to a dummy treatment (placebo) and an existing eczema medication called dupilumab, to see how well it works and if it's safe. It's a Phase II trial, meaning it's still in the earlier stages of testing. Adults aged 18 and over who have moderate to severe eczema may be able to take part.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This study is investigating a new medication called JNJ-95475939, which is being tested for people who have moderate to severe eczema, medically known as atopic dermatitis. Eczema is a very common skin condition that causes skin to become itchy, dry, and red. It can be quite uncomfortable and sometimes leads to a lot of itching and scratching, which can make the skin worse.
We know that eczema often happens because the body's immune system is a bit overactive, leading to inflammation in the skin. This new medicine, JNJ-95475939, is designed to block certain signals in the body that cause this inflammation and the constant itching. By doing so, it's hoped that the medicine could help improve eczema symptoms.
The main goal of this study is to find out how effective JNJ-95475939 is and if it has any side effects, especially when compared to a dummy treatment (placebo) and another medicine already used for eczema called dupilumab. The researchers hope that the results will help them understand if this new medicine could be a good treatment option for people with eczema in the future.
النقاط الرئيسية
- Tests a new medicine (JNJ-95475939) for moderate to severe eczema.
- Compares the new medicine to a dummy treatment and an existing eczema drug.
- Involves adults (18+) with active eczema that hasn't responded well to other treatments.
- Participation lasts up to 41 weeks, including screening, treatment, and follow-up.
- Potential benefits include improved eczema and helping future patients.
- Possible risks include side effects, some of which are not yet fully known.
من قد يكون مؤهلاً؟
This study is looking for adult volunteers, aged 18 or older, who have moderate to severe eczema. Your eczema needs to have started at least a year ago and be affecting a noticeable part of your body (at least 10%). Also, your skin condition will be checked using specific scores to make sure it's moderate to severe at the start of the study, and your itching needs to be at a certain level.
You might be suitable if previous treatments, like creams or other medications, haven't worked well enough for you. You also need to be regularly using moisturiser.
However, you won't be able to join if you've previously had a poor response or serious side effects to similar types of eczema medications (like dupilumab, lebrikizumab, or tralokinumab). Pregnant or breastfeeding individuals, or those planning to become pregnant, cannot take part. If you have other significant skin infections or serious underlying health conditions, you might also not be eligible.
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 18 سنة أو أكثر؟
- Have you been diagnosed with eczema (atopic dermatitis) for at least a year?
- Is your eczema currently moderate to severe and affecting at least 10% of your body?
- Are you regularly using moisturiser at least once a day?
- Have other eczema treatments (creams or medications) not worked well enough for you?
- Are you not pregnant, breastfeeding, or planning to become pregnant?
ماذا يتضمن المشاركة؟
If you join this study, it will last for a total of up to 41 weeks. There are three main parts:
First, there's a 'screening period' of up to 5 weeks. During this time, you'll have checks to see if you're suitable for the study. If you are, you'll move to the next stage.
Then comes the 'treatment period' which lasts up to 24 weeks. You'll be placed into one of five groups by chance, like drawing numbers from a hat. This means you might receive the new medicine (JNJ-95475939) in one of three different doses, an existing medicine (dupilumab), or a dummy treatment (placebo) for the first 12 weeks, before switching to the new medicine for the remaining 12 weeks. All study medicines are given as an injection just under the skin.
Finally, there's a 'follow-up period' of up to 12 weeks. During this time, you won't receive the study medicine, but the team will monitor your health. Throughout the study, you'll have regular checks like physical exams, weight measurements, blood pressure, heart checks (ECG), blood tests, and pregnancy tests (if applicable) to make sure you're safe and to track any changes.
المخاطر والفوائد المحتملة
المواقع (13)
- Guys and St Thomas NHS Foundation Trustغير مؤكدلندن، إنجلترا
- Northwick Park Hospitalغير مؤكدهارو، إنجلترا
- Salford Royal NHS Foundation Trustغير مؤكدSalford, England
- The Queen Elizabeth Hospital, King's Lynn, NHS Foundation Trustغير مؤكدKing's Lynn, England
- Royal London Hospitalغير مؤكدلندن، إنجلترا
- INAER - Investigación en Alergias y Enfermedades Respiratoriasغير مؤكدبوينس آيرس، الأرجنتين
- CETI - Centro de Estudos em Terapias Inovadoras Ltdaغير مؤكدكوريتيبا، البرازيل
- Dermatology Research Institute Incغير مؤكدكالجاري، كندا
- Studienzentrum Dr Schwarz Germanyغير مؤكدLangenau, Germany
- Nomura Dermatology Clinicغير مؤكدYokohama, Japan
- Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilnaغير مؤكدكراكوف، بولندا
- GRUPO DERMATOLOGICO Y ESTETICO PEDRO JAENغير مؤكدمدريد، إسبانيا
أسئلة شائعة
What is atopic dermatitis (eczema)?
It's a common skin condition that makes your skin very itchy, dry, and red. It's often linked to the immune system being overactive.
What does 'Phase II' mean for a trial?
Phase II means the new medicine is being tested in a small group of people to see if it works and to check for potential side effects. It's still an early stage of testing.
هل سأعرف أي علاج سأحصل عليه؟
No, you won't know directly. You'll be randomly assigned to one of five groups, which could be the new medicine, an existing medicine, or a dummy treatment (placebo) at first. This helps ensure the study results are fair.
هل يجب علي الدفع للمشاركة في الدراسة؟
No, there are no costs for participating. The study drug and tests are paid for, and you'll receive reasonable reimbursement for travel and other study-related expenses.
هل يمكنني مغادرة الدراسة في أي وقت؟
نعم، يمكنك الانسحاب من الدراسة في أي وقت ولأي سبب، دون أن يؤثر ذلك على رعايتك الطبية المعتادة.
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