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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.

Em resumo

Status
Ativo, mas não recrutando
Fase
FASE2
Patrocinador
Triveni Bio
Meta de inscrição
95
Iniciar
26 de ago de 2025
Conclusão estimada
01 Jun 2027

Sobre o que é este estudo?

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.

Pontos principais

  • 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.

Quem pode ser elegível?

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.

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.

  1. Você tem entre 18 e 75 anos?
  2. Do you have moderate to severe eczema (atopic dermatitis) that is active right now?
  3. Do you have any other serious or uncontrolled health conditions?
  4. Have you recently used strong eczema treatments like special creams, light therapy, or certain immune-modifying medicines?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

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.

Riscos e benefícios potenciais

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available and closer monitoring of your health by medical professionals. However, there are also potential risks, including side effects from the new medicine, the possibility that the medicine might not help your condition, or the inconvenience of study visits. You will be fully informed of all known and potential risks before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locais (32)

  • Triveni Bio Site #11
    Código postal verificado
    Fountain Valley, United States
  • Triveni Bio Site #4
    Código postal verificado
    San Diego, Estados Unidos
  • Triveni Bio Site #3
    Código postal verificado
    Miami, Estados Unidos
  • Triveni Bio Site #6
    Código postal verificado
    Indianápolis, Estados Unidos
  • Triveni Bio Site #10
    Código postal verificado
    South Bend, United States
  • Triveni Bio Site #1
    Código postal verificado
    Camp Hill, United States
  • Triveni Bio Site #16
    Código postal verificado
    Bellaire, Estados Unidos
  • Triveni Bio Site #5
    Código postal verificado
    Dallas, Estados Unidos
  • Triveni Bio Site #8
    Código postal verificado
    Spokane, United States
  • Triveni Bio Site #38
    Código postal verificado
    Pleven, Bulgaria
  • Triveni Bio Site #39
    Código postal verificado
    Sofia, Bulgaria
  • Triveni Bio Site #13
    Código postal verificado
    Ajax, Canada

Perguntas frequentes

O que é dermatite atópica?

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.

O que é um placebo?

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.

Saberei se estou recebendo o medicamento real ou o placebo?

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.

Quanto tempo estarei no estudo?

Your total time in the study will be up to 57 weeks, including an initial check-up period of up to 30 days.

Como saber mais

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

Discussão

Discussão da comunidade

Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.