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An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).

This research is looking into a new medication, PIT565, for individuals living with Systemic Lupus Erythematosus (SLE). The main goals are to find out if PIT565 is safe to use, how well your body tolerates it, and how it moves through and leaves your system. Researchers also want to discover the right amount of medicine to give. This is a very early study (Phase 1), meaning it's one of the first times this medicine is being tested in people. The medicine will be given as an injection under the skin. As the study progresses, the dose may slowly increase to find the most effective and safest amount, while carefully checking for any side effects.

Em resumo

Status
Recrutamento
Fase
FASE1
Patrocinador
Novartis Farmacêutica
Meta de inscrição
54
Iniciar
08 Oct 2024
Conclusão estimada
17 Nov 2027

Sobre o que é este estudo?

This study is about a new medicine called PIT565 for Systemic Lupus Erythematosus (SLE), or lupus. Lupus is a long-term condition that causes the body's immune system to mistakenly attack its own tissues and organs. Researchers are trying to find new ways to treat it.

In this study, the medicine PIT565 will be given as an injection just under the skin. This is an early-stage study, which means it's one of the first times PIT565 is being tried in people. The main aims are to see how safe it is, how your body reacts to it, and how much of it is needed to be effective. The dose of the medicine may be gradually increased for different groups of participants, but only if it's considered safe to do so.

The study will start with small groups of people, and if the medicine seems safe and shows some helpful effects, more people might join later at specific dose levels. This careful approach helps researchers understand the new medicine step-by-step, ensuring participant safety is always the top priority.

Pontos principais

  • This is an early study (Phase 1) looking at a new lupus medicine called PIT565.
  • The main goals are to check the medicine's safety, how it's handled by the body, and the right dose.
  • PIT565 is given as an injection under the skin.
  • Participants must have active lupus that isn't responding well to current treatments.
  • Careful monitoring and safety checks are a big part of the study.

Quem pode ser elegível?

To join this study, you must be between 18 and 75 years old and have been diagnosed with lupus (SLE) using specific medical guidelines. Your lupus should also be active, meaning you are currently experiencing symptoms, and your current lupus treatments should not be working well enough.

You would not be able to join if you have very severe lupus that has caused significant organ damage or is life-threatening, or if you are having a serious flare-up that needs immediate treatment. Also, if you have severe kidney problems related to lupus that require strong medication, you might not be suitable. Other conditions like serious heart problems, certain severe infections (like HIV or hepatitis), or other serious medical illnesses could also prevent you from taking part.

Women who could become pregnant would need to be using very reliable birth control methods to be considered for the study.

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 a confirmed diagnosis of lupus (SLE)?
  3. Is your lupus currently active, despite your usual treatments?
  4. Have you been vaccinated against common infections like flu and COVID-19?
  5. Do you have any severe organ damage or life-threatening lupus flares?
  6. If you are a woman, are you able to use effective birth control?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to take part, you would receive the study medicine, PIT565, as an injection under your skin. Before each dose, you might receive other medicines to help prevent any reactions. The study involves different groups of people, and the dose of PIT565 might be different for each group, starting low and possibly increasing if it's safe.

The researchers will closely monitor your health and any effects of the medicine. This will involve regular visits to the clinic for check-ups, blood tests, and other assessments. The total time you would be involved in the study is not specified, but early-stage studies like this often involve several weeks or months of close monitoring.

Riscos e benefícios potenciais

Participating in a study like this may offer potential benefits, such as access to a new experimental treatment for lupus before it's widely available, and helping advance medical knowledge for others with the condition. However, there are also potential risks; the medicine PIT565 is new, and not all its side effects are known. You might experience new or unexpected side effects, or it might not help your condition. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

  • Site de Investigação da Novartis
    Código postal verificado
    Sofia, Bulgaria· Retirado
  • Site de Investigação da Novartis
    Código postal verificado
    Pequim, China· Recrutamento
  • Site de Investigação da Novartis
    Código postal verificado
    Pequim, China· Recrutamento
  • Site de Investigação da Novartis
    Código postal verificado
    Berlim, Alemanha· Recrutamento
  • Site de Investigação da Novartis
    Código postal verificado
    Mainz, Germany· Recrutamento
  • Site de Investigação da Novartis
    Código postal verificado
    Budapest, Hungary· Recrutamento
  • Site de Investigação da Novartis
    Código postal verificado
    Szeged, Hungary· Recrutamento
  • Site de Investigação da Novartis
    Código postal verificado
    Leiden, Países Baixos· Recrutamento
  • Site de Investigação da Novartis
    Apenas cidade
    Santiago Compostela, Spain· Recrutamento
  • Site de Investigação da Novartis
    Código postal verificado
    Barcelona, Espanha· Recrutamento
  • Site de Investigação da Novartis
    Código postal verificado
    Madrid, Espanha· Recrutamento
  • Site de Investigação da Novartis
    Código postal verificado
    Bern, Switzerland· Recrutamento

Perguntas frequentes

O que é PIT565?

PIT565 is a new medicine being tested for people with lupus (SLE). It's in the early stages of development.

Por que este estudo é importante?

This study helps researchers understand if PIT565 is safe and how it works in the body, which could lead to a new treatment option for lupus.

Saberei se estou recebendo o medicamento real?

Yes, everyone in this study will receive PIT565. There isn't a placebo (dummy medicine) group.

Como o medicamento será administrado?

The medicine PIT565 will be given as an injection just under the skin.

E se eu me sentir mal durante o estudo?

Your health will be closely monitored, and you can withdraw from the study at any time if you feel unwell or for any other reason.

Como saber mais

Novartis Farmacêutica

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

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