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Ativo, mas não recrutandoFASE3INTERVENCIONISTA

A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo

Non-segmental vitiligo is an autoimmune condition where the body's immune system attacks pigment-making cells, causing pale white patches on the skin. This phase 3 study looks at whether a medicine called ritlecitinib can safely restore skin colour over a longer period. This trial is an extension study. It is only open to people aged 12 and older who have already finished 52 weeks in an earlier study of ritlecitinib. Participants will take a capsule once daily at home for up to 52 weeks. The capsule will contain either ritlecitinib or a dummy pill (placebo). Taking part lasts up to 60 weeks and involves 9 hospital or clinic visits. Doctors will monitor skin changes and overall health. The results will help doctors learn if keeping up treatment maintains skin colour, if a higher dose helps more, and how safe the medicine is long-term.

Em resumo

Status
Ativo, mas não recrutando
Fase
FASE3
Patrocinador
Pfizer
Meta de inscrição
394
Iniciar
19 de jan. de 2024
Conclusão estimada
31 Mar 2027

Sobre o que é este estudo?

Vitiligo is a long-term skin condition where areas of the skin lose their natural colour, leaving smooth, pale white patches. In non-segmental vitiligo, which is the most common form, the immune system mistakenly attacks the cells that produce skin pigment (melanin). These patches often appear symmetrically on both sides of the body, such as on the hands, face, or joints. While vitiligo is not dangerous to overall physical health, it can have a big emotional impact on people living with it.

Ritlecitinib is an oral medicine that works by calming down specific signals in the immune system. By turning down this inflammation, the medicine may allow the skin's pigment-producing cells to recover and bring back natural skin colour. Ritlecitinib is already approved in some countries for severe alopecia areata (an autoimmune hair loss condition), but researchers are still testing how well and safely it works for vitiligo.

This trial is an extension study, meaning it follows on directly from an earlier 52-week clinical study. Researchers want to find out what happens over another full year of treatment. They want to see whether the colour that returned during the first study stays the same, whether taking a higher dose brings back even more colour, or how quickly skin colour fades if someone switches to a dummy pill (placebo).

Pontos principais

  • This is a follow-on study testing ritlecitinib for non-segmental vitiligo.
  • Only people who completed 52 weeks in the earlier trial can take part.
  • Participants take one capsule daily by mouth for up to 52 weeks.
  • The study includes 9 clinic visits over a maximum of 60 weeks.
  • Treatment may be ritlecitinib (50 mg or 100 mg) or a dummy pill (placebo).

Quem pode ser elegível?

This study is only open to people who have already taken part in the earlier 'parent' study (Study B7981040). You must have completed the full 52 weeks of treatment in that first study for non-segmental vitiligo. Your first visit for this new trial must take place within 30 days of finishing the previous one.

Participants must be aged 18 or older, or aged 12 to 17 where local health authorities and ethics committees have approved adolescent participation. Both active vitiligo (patches that are still spreading) and stable vitiligo are included.

You will not be able to take part if you had to leave the earlier study early due to health or safety concerns. You also cannot join if you have serious blood test abnormalities or current thoughts of self-harm or suicide, as safety is the top priority.

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. I took part in and completed 52 weeks of the parent study (Study B7981040).
  2. It has been 30 days or fewer since my final week 52 visit in that study.
  3. I am aged 18 or older, or aged 12-17 with local adolescent approval.
  4. I have non-segmental vitiligo.
  5. I did not have to stop the earlier study because of safety issues or bad side effects.
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

Taking part in this study lasts for up to 60 weeks in total. During this time, you will visit the study clinic approximately 9 times. At these visits, the study team will carry out health checks, such as examining your skin patches, taking blood samples, and asking how you are feeling.

You will take one capsule by mouth every day at home for up to 52 weeks. Depending on which group you are placed in, your capsule will contain ritlecitinib (50 mg or 100 mg) or a placebo (a lookalike capsule with no active medicine). On the days you have a clinic appointment, you will need to wait and take your daily capsule at the clinic instead of at home. After finishing treatment, there will be a follow-up period to check on your health.

Riscos e benefícios potenciais

A potential benefit is that the study medicine may help restore skin colour or stop white patches from spreading, though this cannot be guaranteed. You will also receive close, regular health checks from skin specialists. However, there are risks of side effects from ritlecitinib, which the study doctor will explain in detail. There is also a chance you may receive a placebo, which contains no active medicine. Taking part is completely voluntary. You can choose to leave the study at any time without giving a reason, and your normal NHS care will not be affected.

Locations (73)

  • California Dermatology & Clinical Research Institute
    Código postal verificado
    Encinitas, United States
  • Marvel Clinical Research
    Código postal verificado
    Huntington Beach, Estados Unidos
  • Wallace Medical Group, Inc
    Código postal verificado
    Los Angeles, Estados Unidos
  • Encore Medical Research of Boynton Beach
    Código postal verificado
    Boynton Beach, Estados Unidos
  • Skin Care Research
    Código postal verificado
    Hollywood, Estados Unidos
  • ForCare Clinical Research
    Código postal verificado
    Tampa, Estados Unidos
  • Dawes Fretzin Clinical Research Group, LLC
    Código postal verificado
    Indianápolis, Estados Unidos
  • DelRicht Research
    Código postal verificado
    Baton Rouge, United States
  • Lawrence J. Green, MD LLC
    Código postal verificado
    Rockville, United States
  • Universidade de Michigan
    Código postal verificado
    Ann Arbor, Estados Unidos
  • University of New Mexico Health Sciences Center
    Código postal verificado
    Albuquerque, United States
  • SUNY Downstate Health Sciences University
    Código postal verificado
    Brooklyn, United States

Perguntas frequentes

Can I join this study if I did not take part in the first study?

No. This trial is only open to people who successfully finished all 52 weeks of the earlier vitiligo study (Study B7981040).

O que é um placebo?

A placebo looks and tastes like the real study drug, but it contains no active medicine. It helps researchers understand whether changes in skin colour are truly caused by the drug.

How is the medicine taken?

It is taken as a single capsule swallowed by mouth once a day at home, except on clinic visit days when you take it at the study site.

Will I have to pay for the study treatment?

No. The study medication, tests, and medical visits related to the trial are provided free of charge, and travel expenses are often covered.

What happens if I want to stop taking part?

You are free to leave the trial at any point. Your decision will not change how your doctors care for you in the future.

Como saber mais

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

Discussão

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