A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD)
This research study is looking at a new medicine called JNJ-95475939 for adults who have troublesome eczema (moderate to severe atopic dermatitis). The aim is to find out how well this new medicine works compared to a 'dummy' medicine (placebo) in improving eczema symptoms. Some people will receive JNJ-95475939, others will receive an existing medicine called Dupilumab, and some will receive the placebo. The study will help us understand if JNJ-95475939 could be a helpful new treatment option for people whose eczema hasn't responded well to other treatments. Participants will be carefully monitored throughout the study.
Em resumo
Sobre o que é este estudo?
This study is about understanding how well a new medicine, JNJ-95475939, works for adults who have a skin condition called eczema, also known as atopic dermatitis. Eczema can make your skin very dry, itchy, and red, and for some people, it can be quite severe and impact their daily life. The study aims to compare JNJ-95475939 with a dummy medicine (placebo) and also with an existing treatment called Dupilumab. This helps researchers figure out if the new medicine is effective and safe.
The main goal is to see if JNJ-95475939 can improve the skin condition and reduce the intense itching that often comes with eczema. By comparing it to a placebo, researchers can be sure that any improvements are due to the medicine itself and not just chance. Comparing it to an existing medicine helps to understand if it could be a valuable new option for people who haven't found enough relief from current treatments.
Taking part in a study like this helps advance medical knowledge and could lead to new and better treatments for eczema in the future. It's a way for people with specific types of eczema to potentially access a new medicine that isn't widely available yet, while also contributing to important research.
Pontos principais
- This study is for adults with moderate to severe eczema that hasn't responded to previous treatments.
- It tests a new medicine (JNJ-95475939) against an existing one (Dupilumab) and a dummy medicine (placebo).
- The main goal is to see if the new medicine improves eczema symptoms and itching.
- Participation involves regular clinic visits, physical exams, and blood tests.
- You won't know which treatment you receive to ensure fair results.
- Você pode parar de participar a qualquer momento.
Quem pode ser elegível?
This study is looking for adults aged 18 or older who have had eczema (atopic dermatitis) for at least a year. Your eczema must be considered moderate to severe, meaning it affects a noticeable area of your body and is causing significant symptoms like itching.
To be considered, your eczema shouldn't have improved enough with creams or other medicines you've tried in the past. You should also be regularly using a moisturiser. Certain health conditions, like other skin problems or severe organ issues, would mean you couldn't take part. Also, if you are pregnant, breastfeeding, or planning to be, this study is not for you.
If you have previously had a significant bad reaction or no improvement from certain types of eczema medicines (like Dupilumab), you might also not be able to join. The study doctors will carefully check all your health information to make sure it's safe and appropriate for you to participate.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Você tem 18 anos ou mais?
- Have you had eczema (atopic dermatitis) for at least a year?
- Is your eczema considered moderate to severe and bothersome?
- Have creams or other eczema medicines not worked well enough for you?
- Are you currently not pregnant or breastfeeding, and not planning to be during the study?
- Do you use moisturiser at least once a day?
O que envolve a participação?
If you decide to take part, you'll have regular visits to the clinic. These visits will involve various checks to see how your eczema is progressing and how you are feeling generally. You'll have your skin examined, and doctors will ask you questions about your symptoms, especially about how much your skin itches. You'll also likely give blood samples at these visits.
You will receive either the study medicine (JNJ-95475939), Dupilumab, or a placebo (a dummy medicine with no active ingredients). Which one you receive will be decided by chance, like flipping a coin. You won't know which one you're getting, nor will the study team, to keep the results fair. You will be given instructions on how to take the medicine, which will likely be injections given by you or a nurse.
The study will last for several months, with regular check-ups and assessments during this time. There will also be follow-up appointments after you stop taking the study medicine to ensure your safety and monitor any long-term effects. The clinic staff will explain the full schedule of visits and procedures if you are interested.
Riscos e benefícios potenciais
Locations (71)
- First OC DermatologyCódigo postal verificadoFountain Valley, United States
- University of California Los Angeles - Division of DermatologyCódigo postal verificadoLos Angeles, Estados Unidos
- Hamilton Research LLCCódigo postal verificadoAlpharetta, United States
- DeNova ResearchCódigo postal verificadoChicago, Estados Unidos
- Dawes Fretzin Clinical Research Group LLCCódigo postal verificadoIndianápolis, Estados Unidos
- Indiana Clinical Trial CenterCódigo postal verificadoPlainfield, United States
- Red River Research Partners LLCCódigo postal verificadoFargo, United States
- Optima ResearchCódigo postal verificadoBoardman, United States
- Oregon Medical Research CenterCódigo postal verificadoPortland, Estados Unidos
- Arlington Center for DermatologyCódigo postal verificadoArlington, United States
- Center for Clinical StudiesCódigo postal verificadoHouston, Estados Unidos
- Progressive Clinical ResearchCódigo postal verificadoSan Antonio, United States
Perguntas frequentes
O que é dermatite atópica?
Atopic dermatitis is a common type of eczema that makes your skin dry, red, and very itchy. It's a long-lasting condition.
O que é um 'placebo'?
A placebo is a 'dummy' medicine that looks like the real thing but contains no active drug. It helps researchers see if the actual medicine is truly working.
Will I know if I'm getting the new medicine?
No, you won't know if you're getting the new medicine, Dupilumab, or the placebo. This is to ensure the study results are fair and unbiased.
Quanto tempo durará o estudo?
The study will involve several months of treatment and follow-up, with regular visits to the clinic during that time.
Posso sair do estudo se mudar de ideia?
Yes, you are free to leave the study at any time, for any reason, without affecting your medical care.
Como saber mais
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
Discussão
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Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.