Todos os estudos
Ativo, mas não recrutandoFASE3INTERVENCIONISTA

A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines

This study is investigating a new medication called zasocitinib for adults living with psoriatic arthritis. Psoriatic arthritis is a long-term condition that affects your joints and skin, especially if you have psoriasis. The main goal is to find out how effective zasocitinib is in people with active psoriatic arthritis, regardless of whether they've used other specific treatments in the past. Participants will either receive zasocitinib or a placebo (a dummy drug). The study will last for up to 60 weeks. This research hopes to provide more options for managing psoriatic arthritis symptoms.

Em resumo

Status
Ativo, mas não recrutando
Fase
FASE3
Patrocinador
Takeda
Meta de inscrição
601
Iniciar
10 Mar 2025
Conclusão estimada
26 Jan 2028

Sobre o que é este estudo?

This study is all about a new potential medicine called zasocitinib. It's being tested for adults diagnosed with psoriatic arthritis. Psoriatic arthritis is a condition that causes inflammation in your joints and can affect your skin if you also have psoriasis. The idea is to see if zasocitinib can help reduce the symptoms of this condition.

The main question the researchers want to answer is: how well does zasocitinib work for people who have active psoriatic arthritis? They're especially interested in how it affects people who have or haven't tried certain other treatments for their condition before. To test this, some people will receive zasocitinib, while others will receive a placebo. A placebo looks like the real medicine but contains no active drug, which helps researchers understand if any improvements are truly due to the new drug.

Taking part in a study like this helps doctors learn more about new treatments. This information is really important because it could lead to new ways to help people manage their psoriatic arthritis in the future. The study will last for just over a year, around 60 weeks, to properly assess the effects of the treatment.

Pontos principais

  • The study is for adults with active psoriatic arthritis.
  • It's testing a new drug called zasocitinib against a dummy drug (placebo).
  • It includes people who have tried other psoriatic arthritis treatments and those who haven't.
  • Participation lasts about 60 weeks and involves regular clinic visits.
  • The aim is to find out how well zasocitinib helps manage psoriatic arthritis symptoms.

Quem pode ser elegível?

To join this study, you need to be an adult, aged 18 or older, and have received a diagnosis of psoriatic arthritis. Your psoriatic arthritis should have been active for at least three months, with a certain number of tender and swollen joints. You'll also need to have at least one active patch of psoriasis on your skin or changes to your nails typical of psoriasis.

The study is looking for people who haven't responded well to other common treatments for psoriatic arthritis. This could mean treatments like NSAIDs (painkillers), or standard disease-modifying drugs, or even up to two different biologic treatments.

However, you wouldn't be able to join if you have other conditions that might make it hard to tell if zasocitinib is working, such as rheumatoid arthritis, lupus, or gout. Also, if you have certain types of psoriasis that are not the ‘plaque’ type, or if your doctor thinks another skin condition might interfere with the study, you might not be suitable.

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. Do you have a diagnosis of psoriatic arthritis that's been active for at least 3 months?
  3. Do you have some tender and swollen joints?
  4. Do you have a patch of psoriasis or changes to your nails characteristic of psoriasis?
  5. Have you tried and not responded well to certain other psoriatic arthritis medicines in the past?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to take part, you'll be in the study for up to 60 weeks (about 14 months). During this time, you'll either receive the new drug, zasocitinib, or a placebo (a dummy drug). You won't know which one you're getting, and neither will your study doctor, until the study is over. You'll have regular visits to the clinic where doctors will assess your joints, skin, and overall health to see how you're responding. There will also be follow-up appointments to monitor your progress and safety. All instructions for taking the medication will be given to you by the study team.

Riscos e benefícios potenciais

Taking part in a clinical trial can offer potential benefits, such as access to a new treatment before it's widely available and closer monitoring of your health. However, there are also potential risks, as any new drug can have side effects that aren't fully known yet. You might not receive the active drug and could be given a placebo, meaning your symptoms might not improve. The research team will explain all known risks to you. Remember, joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (120)

  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
    Código postal verificado
    Mesa, Estados Unidos
  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
    Código postal verificado
    Phoenix, Estados Unidos
  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
    Código postal verificado
    Tucson, Estados Unidos
  • Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA
    Código postal verificado
    Covina, United States
  • RASF- Clinical Research Center
    Código postal verificado
    Boca Raton, United States
  • Direct Helpers Medical Center
    Código postal verificado
    Hialeah, Estados Unidos
  • IRIS Research and Development | Plantation, FL
    Código postal verificado
    Plantation, United States
  • BayCare Medical Group
    Código postal verificado
    São Petersburgo, Estados Unidos
  • North Georgia Rheumatology Group PC
    Código postal verificado
    Lawrenceville, United States
  • Clinic of Robert Hozman
    Código postal verificado
    Skokie, United States
  • Graves Gilbert Clinic
    Código postal verificado
    Bowling Green, United States
  • Johns Hopkins Hospital
    Código postal verificado
    Baltimore, Estados Unidos

Perguntas frequentes

O que é artrite psoriática?

Psoriatic arthritis is a type of arthritis that affects some people who have psoriasis. It causes joint pain, stiffness, and swelling.

O que é um placebo?

A placebo is a 'dummy' treatment that looks just like the study drug but doesn't contain any active medicine. It helps doctors see if the real drug is truly effective.

Quanto tempo estarei no estudo?

You will be in the study for up to 60 weeks, which is about 14 months.

Will I have to pay for the treatment or visits?

No, all study-related treatments, tests, and visits are provided at no cost to you.

Posso sair do estudo a qualquer momento?

Yes, your participation is voluntary, and you can withdraw from the study whenever you want to, without giving a reason.

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.