An Open-label Study of AZD0120 in Adults With Multiple Sclerosis
This study is looking at a new treatment called AZD0120 for adults living with multiple sclerosis (MS). It's quite an early stage of testing, known as 'Phase 1', which means the main goal is to check how safe the treatment is and if people can handle it without too many problems. Researchers will be carefully watching for any side effects and trying to find the best dose to use in future studies. The study involves a small number of participants, roughly 9-12 people for each type of MS being investigated. This treatment uses a clever approach involving special modified cells to target specific parts of the immune system that cause MS. The aim is to gather important information before moving on to larger studies.
Em resumo
Sobre o que é este estudo?
This study is about a new treatment, called AZD0120, for adults who have multiple sclerosis (MS). MS is a condition that affects your brain and spinal cord, which can lead to a wide range of symptoms. This new treatment, AZD0120, is a special type of cell therapy that works by targeting certain cells in your body that are thought to play a role in MS. It's a bit like giving your immune system a special instruction to help it work better and stop attacking itself.
Because this is a new treatment, the very first step in testing it is to make sure it's safe and that people can tolerate it well. This study is what's called a 'Phase 1' study, meaning that safety is the top priority. Doctors will be looking very closely for any side effects and trying to figure out the best amount of the treatment (the 'dose') to use. This information is really important because it helps scientists decide if and how to continue testing the treatment in larger groups of people.
The study is 'open-label', which means both you and your doctors will know which treatment you are receiving. It's also being carried out in several different hospitals or clinics (multi-center). By taking part, you would be helping researchers learn more about MS and potentially find new ways to treat it in the future. It's a vital step in medical research.
Pontos principais
- This study is for adults with multiple sclerosis (MS).
- It's testing a new treatment called AZD0120 to see if it's safe.
- The study aims to find the right dose of the treatment.
- It involves close monitoring by doctors and nurses.
- Você pode se retirar do estudo a qualquer momento.
Quem pode ser elegível?
To be able to take part in this study, you need to be an adult between 18 and 60 years old. You also need to be generally well enough to participate, meaning your body needs to be functioning adequately – your doctors will check this. You'd also need to agree to take part by giving your written permission, known as 'informed consent'.
The study is looking at different types of MS. If you have what's called 'Relapsing Multiple Sclerosis' (RMS) or 'active Secondary Progressive MS' (SPMS), you might be eligible if: your symptoms have varied over time, you meet specific diagnostic criteria, you have a certain level of disability (rated on a scale where lower numbers mean less disability), and your MS has shown recent activity or you haven't responded well to other strong treatments for at least six months.
If you have 'Primary Progressive MS' (PPMS) or 'non-relapsing Secondary Progressive MS' (SPMS), you might be eligible if: your symptoms have steadily worsened, you meet specific diagnostic criteria, your disability level falls within a certain range, and you haven't responded well to at least one strong MS treatment for at least six months. There are also reasons why you might not be able to join, such as having had similar cell therapies before, certain heart conditions, or other serious brain conditions like epilepsy or a history of stroke.
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.
- Are you between 18 and 60 years old?
- Do you have a diagnosis of Relapsing MS (RMS), active Secondary Progressive MS (SPMS), Primary Progressive MS (PPMS), or non-relapsing SPMS?
- Are you generally well enough for a study, as determined by a doctor?
- Have you not responded well to at least one strong MS treatment for 6 months or more, or shown recent MS activity?
- Have you never had a specific type of cell therapy (CAR-T or CAR-NK) before?
- Do you have any serious heart conditions or other major brain conditions like epilepsy or a history of stroke?
O que envolve a participação?
If you join this study, you would receive the investigational treatment, AZD0120. There are two different ways (regimens) in which it might be given, and the doctors will decide which one is most suitable for you. Because this is a safety study, you can expect to have a number of visits to the clinic so that doctors and nurses can closely monitor your health. They will perform health checks, blood tests, and scans to see how you are responding to the treatment and to check for any side effects.
The exact number of visits, tests, and the total duration of your participation would be explained in detail by the study team. They will let you know how long you would need to be involved and what each visit would entail. You would be fully informed about everything before making a decision.
Riscos e benefícios potenciais
Localizações (19)
- Site de PesquisaCódigo postal verificadoTucson, Estados Unidos· Retirado
- Site de PesquisaCódigo postal verificadoAurora, Estados Unidos· Ainda não recrutando
- Site de PesquisaCódigo postal verificadoWashington D.C., Estados Unidos· Recrutamento
- Site de PesquisaCódigo postal verificadoSt Louis, Estados Unidos· Recrutamento
- Site de PesquisaCódigo postal verificadoNova Iorque, Estados Unidos· Recrutamento
- Site de PesquisaCódigo postal verificadoNova Iorque, Estados Unidos· Recrutamento
- Site de PesquisaCódigo postal verificadoCleveland, Estados Unidos· Ainda não recrutando
- Site de PesquisaCódigo postal verificadoSeattle, Estados Unidos· Recrutamento
- Site de PesquisaCódigo postal verificadoMilwaukee, United States· Recrutamento
- Site de PesquisaCódigo postal verificadoLiverpool, Australia· Ainda não recrutando
- Site de PesquisaCódigo postal verificadoMelbourne, Austrália· Recrutamento
- Site de PesquisaCódigo postal verificadoMelbourne, Austrália· Ainda não recrutando
Perguntas frequentes
What is multiple sclerosis (MS)?
MS is a condition that affects your brain and spinal cord, which are parts of your central nervous system. It can cause a wide range of symptoms like tiredness, problems with walking, and changes in vision.
What is AZD0120?
AZD0120 is a new, experimental treatment being tested for MS. It's a type of cell therapy designed to target specific cells in your body that are involved in MS.
What does 'Phase 1' study mean?
A Phase 1 study is the first step in testing a new treatment in people. The main goal is to find out if the treatment is safe and what dose can be given without causing too many problems.
Will I know if I'm getting the treatment?
Yes, this is an 'open-label' study, which means both you and your doctors will know that you are receiving the AZD0120 treatment.
Posso sair do estudo a qualquer momento?
Yes, taking part in a study is always voluntary. You can choose to leave the study at any point, and your decision will not affect your future medical care.
Como saber mais
Centro de Informações de Estudos Clínicos da AstraZeneca
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
Interessado em participar?
Discussão
Discussão da comunidade
Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.