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RecrutamentoFarmacologia Humana (Fase I) - OutrosIntervencionista

Multiple Ascending Doses of BMS-986326 in Participants with Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, or Systemic Lupus Erythematosus

This early-stage study is looking into a new medication called BMS-986326. It's for adults (18 years and older) who have different types of lupus, specifically discoid lupus erythematosus (DLE), subacute cutaneous lupus erythematosus (SCLE), or systemic lupus erythematosus (SLE). The main goal is to understand how different amounts (doses) of this new medicine behave in the body and what effects it might have. This includes checking how safe it is and if there are any common side effects. This kind of study helps researchers learn important information about new medicines before they are tested in more people, moving towards finding potential new treatments for lupus. It's a key first step in developing new medicines.

Em resumo

Status
Recrutamento
Fase
Farmacologia Humana (Fase I) - Outros
Patrocinador
Bristol-Myers Squibb Services Unlimited Company
Meta de inscrição
37
Iniciar
20 Nov 2023

Sobre o que é este estudo?

This research study is about exploring a new medication known as BMS-986326. It's designed for people living with certain types of lupus, including discoid lupus, subacute cutaneous lupus, or systemic lupus. Lupus is a long-term condition that can cause inflammation and a range of symptoms, often affecting the skin, joints, and internal organs. The aim of studies like these is to find new and more effective ways to manage the condition and improve the lives of those affected.

This particular study is in its very early stages, often called a 'Phase I' study. This means it's one of the first times the new medication is being tested in humans. The main purpose is to learn how the medicine works in the body, such as how it's absorbed, distributed, broken down, and removed. Researchers will be giving different doses of the medicine to see how the body reacts to each amount. This helps them find a safe and effective dose to study further.

By taking part, individuals would be helping scientists gather crucial information. This early insight into the medicine's safety and how it behaves in the human body is essential. It helps determine if the medicine is promising enough to continue into larger studies, ultimately moving closer to potentially offering another treatment option for people with lupus.

Pontos principais

  • Tests a new medicine (BMS-986326) for lupus.
  • Early stage study (Phase I) focused on safety and dose.
  • For adults (18+) with discoid, subacute cutaneous, or systemic lupus.
  • Involves regular clinic visits and health checks.
  • Participation helps advance lupus research.
  • Você pode parar de participar a qualquer momento.

Quem pode ser elegível?

To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

Crucially, you must have been diagnosed with one of the specific types of lupus the study is focusing on: discoid lupus erythematosus, subacute cutaneous lupus erythematosus, or systemic lupus erythematosus. Your medical team will be able to confirm whether your diagnosis fits these criteria.

There will also be other specific health requirements and medical checks to make sure the study is safe for you and that the results will be clear. For example, they will check your overall health and any other medications you might be taking. A doctor from the study team will discuss all these details with you.

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 18 anos ou mais?
  2. Have you been diagnosed with discoid lupus, subacute cutaneous lupus, or systemic lupus?
  3. Are you able to attend regular appointments at a clinic?
  4. Are you willing to discuss your full medical history with the study team?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to take part in this study, you would first have a screening visit to make sure you meet all the health requirements. If eligible, you would then receive the study medication, BMS-986326, at different dose levels. The study involves a series of visits to the clinic where doctors and nurses will monitor your health closely, perform examinations, take blood and urine samples, and ask about any new symptoms or side effects you might experience. They will be checking how the medicine affects your body and how your lupus symptoms change. The total duration of your participation, including follow-up appointments after you stop taking the study drug, would be clearly explained by the research team.

Riscos e benefícios potenciais

Participating in a study like this may offer some potential benefits, such as contributing to scientific knowledge and potentially helping develop new treatments for lupus. You will also receive careful medical monitoring from the study team throughout your participation. However, there are also potential risks involved. Since this is a new medication, not all side effects are known, and you might experience unexpected reactions. There's also no guarantee that the medication will improve your lupus. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Localizações (6)

Algumas localizações dos sites são aproximadas. Estamos melhorando isso — por favor, verifique com a equipe de teste antes de viajar.
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    Não verificado
    Países Baixos
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    Não verificado
    Polônia
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    Não verificado
    Romênia
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    Não verificado
    Alemanha
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    Não verificado
    Espanha
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    Não verificado
    Bulgária

Perguntas frequentes

What kind of new medicine is BMS-986326?

It's a new medicine being tested for people with lupus. We're in the early stages of understanding how it works in the body and if it's safe.

Quem pode participar deste estudo?

Adults aged 18 and over who have been diagnosed with discoid lupus, subacute cutaneous lupus, or systemic lupus.

What is a 'Phase I' study?

It's an early stage where a new medicine is first tested in humans. The main goals are to check its safety and understand how the body handles different doses.

Will I definitely get the new medicine if I join?

Yes, if you meet the eligibility criteria and join this specific study, you would receive the investigational medicine BMS-986326.

O que acontece se eu mudar de ideia durante o estudo?

You can leave the study at any time you wish, and it won't affect the medical care you receive for your lupus.

Como saber mais

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

Interessado em participar?

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