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A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2

This research study is investigating an oral medicine, ritlecitinib, for vitiligo, a condition where the skin loses its colour in patches. The study aims to understand how safe and effective ritlecitinib is for adults with nonsegmental vitiligo, which can affect both sides of the body. Currently, there are no approved oral medications for this type of vitiligo. Participants will be randomly given ritlecitinib or a dummy capsule (placebo) in one part of the study, lasting about 26 months, or receive only ritlecitinib in another part, lasting about 14 months. The study will involve various health checks, questionnaires, and photographs to monitor progress and safety.

Em resumo

Status
Ativo, mas não recrutando
Fase
FASE3
Patrocinador
Pfizer
Meta de inscrição
1,571
Iniciar
08 Nov 2023
Conclusão estimada
30 Jul 2027
Stable Nonsegmental VitiligoActive Nonsegmental Vitiligo

Sobre o que é este estudo?

This study is called Tranquillo 2, and it's looking into a new oral medicine called ritlecitinib. The main goal is to find out if ritlecitinib is a safe and effective treatment for nonsegmental vitiligo in adults. Vitiligo is a skin condition where the cells that give your skin its colour are destroyed, leading to white patches. Nonsegmental means these patches can appear on both sides of your body, for example, on both knees or both hands.

Ritlecitinib has been tested in earlier studies and has shown a promising safety profile. It’s important to remember that at the moment, there aren't any approved medicines that you can take by mouth specifically to treat nonsegmental vitiligo. This study hopes to provide more information on whether ritlecitinib could fill this gap.

The study is divided into two main parts. In Part I, some participants will receive different doses of ritlecitinib, while others will receive a placebo – a capsule that looks like the study medicine but contains no active ingredient. This helps researchers compare the effects. In Part II, everyone will receive ritlecitinib. By comparing the experiences of people taking ritlecitinib with those who don't, the researchers can learn if the medicine is safe and if it helps improve vitiligo.

Pontos principais

  • This study is testing ritlecitinib for nonsegmental vitiligo.
  • It's for adults aged 18 and over with a vitiligo diagnosis of at least 3 months.
  • Participants will either be given ritlecitinib or a placebo, or only ritlecitinib depending on the study part.
  • The study lengths vary from about 14 to 26 months, with regular clinic visits.
  • Various health checks, photos, and questionnaires will be part of the process.
  • Você pode se retirar do estudo a qualquer momento.

Quem pode ser elegível?

This study is looking for adult volunteers, aged 18 or older. To be considered, you must have been diagnosed with nonsegmental vitiligo for at least three months.

Your vitiligo also needs to cover a certain amount of your body, including some areas on your face, but not include the palms of your hands or soles of your feet. You might have 'active' vitiligo (meaning it's currently changing or spreading) or 'stable' vitiligo (where it's not changing much).

If you're currently using other treatments for your vitiligo, you'll need to be ready to stop them if you join the study. The study team will be able to tell you if the study is right for you after checking all your health details.

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 nonsegmental vitiligo for at least 3 months?
  3. Are you willing to stop any other vitiligo treatments?
  4. Does your vitiligo affect a certain amount of your body, including some on your face (but not just palms/soles)?
  5. Are you able to attend regular study visits for over a year (up to 26 months)?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you join the study, you'll be assigned by chance to one of the treatment groups – like drawing names from a hat. In Part I, you could receive one of two different doses of ritlecitinib or a dummy capsule (placebo) once a day. If you're in the placebo group and your vitiligo hasn't responded after 52 weeks, you'll then switch to taking ritlecitinib for the rest of the study. In Part II, all participants will receive a specific dose of ritlecitinib.

Participation in Part I will last about 26 months, involving at least 17 visits to the study site. If you're in Part II, it will be around 14 months with at least 11 visits. During these visits, you'll have various health checks, such as physical exams, blood tests, hearing tests, an X-ray, and an ECG (heart check). They'll also take photographs of your vitiligo patches and ask you to complete questionnaires about your condition.

Riscos e benefícios potenciais

Like all medicines and research studies, there could be potential benefits and risks. The potential benefit is that ritlecitinib might help improve your vitiligo symptoms, as there are currently no approved oral treatments. However, there's also the chance the medicine might not work for you, or you might experience side effects. The study team will carefully monitor your health and any side effects throughout. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (229)

  • Center for Dermatology and Plastic Surgery/CCT Research
    Código postal verificado
    Scottsdale, Estados Unidos
  • Dermatology Trial Associates
    Código postal verificado
    Bryant, United States
  • First OC Dermatology Research Inc
    Código postal verificado
    Fountain Valley, United States
  • Seaside Audiology Vertigo & Ear Specialists
    Código postal verificado
    Huntington Beach, Estados Unidos
  • Wallace Medical Group, Inc
    Código postal verificado
    Los Angeles, Estados Unidos
  • Kaiser Permanente
    Código postal verificado
    Oakland, Estados Unidos
  • Cura Clinical Research - Oxnard
    Código postal verificado
    Oxnard, United States
  • Mission Dermatology Center
    Código postal verificado
    Rancho Santa Margarita, United States
  • Peninsula Research Associates
    Código postal verificado
    Rolling Hills Estates, United States
  • Integrative Skin Science and Research
    Código postal verificado
    Sacramento, Estados Unidos
  • University of California San Diego - La Jolla
    Código postal verificado
    San Diego, Estados Unidos
  • Wolverine Clinical Trials
    Código postal verificado
    Santa Ana, United States

Perguntas frequentes

What is nonsegmental vitiligo?

It's a skin condition causing white patches when colour-making cells are destroyed, and it can affect both sides of your body.

O que é um placebo?

A placebo is a dummy capsule that looks like the actual medicine but doesn't contain any active drug. It helps researchers compare effects.

Quanto tempo dura o estudo?

It depends on which part of the study you're in; it's either about 26 months (Part I) or 14 months (Part II).

Will I have to stop other vitiligo treatments?

Yes, if you're taking other treatments for vitiligo, you'll need to be willing to stop them to join the study.

What kind of tests will I have?

You'll have physical exams, blood tests, hearing tests, X-rays, ECGs, and photos of your vitiligo, plus questionnaires.

Como saber mais

Registro oficial do julgamento

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

Discussão

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