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A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.

This study is for children with severe alopecia areata, a condition that causes significant hair loss. It's a long-term study to find out more about a medicine called ritlecitinib. The main goal is to see how safe the medicine is and how well it works over a longer period. Only children who have already taken part in one of Pfizer's earlier studies (B7981027 or B7981031) for alopecia areata can join this study. All participants will receive ritlecitinib, taken as a daily capsule. The study will last up to three years and involves regular visits to the clinic and phone calls to check on progress.

Em resumo

Status
Recrutamento
Fase
FASE3
Patrocinador
Pfizer
Meta de inscrição
140
Iniciar
10 Sep 2025
Conclusão estimada
26 Jun 2030
Severe Alopecia Areata

Sobre o que é este estudo?

This research study is looking into a medicine called ritlecitinib for children and young people who have severe alopecia areata. Alopecia areata is a condition where the body's immune system mistakenly attacks hair follicles, leading to hair loss, sometimes all over the head or body. Severe means a lot of hair loss, in this case, affecting at least half of the scalp.

The main aim of this study is to understand the long-term effects of ritlecitinib. We want to see how safe it is to take over a longer period and how well it helps with hair regrowth. The study is a continuation for children who have already taken part in a previous Pfizer study (named B7981027 or B7981031) looking at the same medicine. This means we're building on what we've already learned.

All participants will receive the study medicine, ritlecitinib, which is taken as a capsule once a day. Some participants will receive a higher dose, and others a lower dose. We hope this study will give us important information about how ritlecitinib can help children manage their alopecia areata in the long run.

Pontos principais

  • This study is for children with severe alopecia areata who were in prior Pfizer studies.
  • It aims to understand the long-term safety and effects of ritlecitinib.
  • Participants take a daily capsule of ritlecitinib (either a higher or lower dose).
  • The study lasts up to 3 years and involves clinic visits and phone calls.
  • It helps researchers learn more about how to treat alopecia areata.
  • Your health and safety will be carefully monitored throughout the study.

Quem pode ser elegível?

To be able to join this study, children must have previously taken part in one of Pfizer's earlier studies for alopecia areata (either B7981027 or B7981031). If they are joining from study B7981031, they need to have lost at least half of their scalp hair due to alopecia areata.

There are also some health requirements. Participants must have had the chickenpox vaccine (two doses) or have had chickenpox before, confirmed by a blood test. There are certain health conditions or past serious infections, including some types of cancer or long-term infections like TB or hepatitis, that would prevent someone from joining to ensure their safety.

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. Have I previously taken part in Pfizer's study B7981027 or B7981031?
  2. If I was in study B7981031, do I have at least 50% hair loss on my scalp?
  3. Have I had two chickenpox vaccinations or had chickenpox before?
  4. Do I have any current or past serious health issues like certain cancers or untreated infections (like TB or hepatitis)?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you join this study, you will take the study medicine, ritlecitinib, once a day as a capsule. You will be in the study for up to three years (36 months). During this time, you will have 17 visits to the study clinic for check-ups and assessments. The study team will also call you once a month to see how you are doing. These visits and calls help the doctors monitor your health and see how well the medicine is working. If the medicine isn't helping as expected after a certain time, or if there are safety concerns, your participation in the study medicine part might stop.

Riscos e benefícios potenciais

Taking part in this study could offer the potential benefit of continuing treatment for your alopecia areata with ritlecitinib, which may help with hair regrowth. However, like all medicines, ritlecitinib can have side effects, and the study will carefully monitor for any potential risks. You will be told about all known risks before you decide to join. Remember, participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (67)

  • University of California~ Irvine
    Código postal verificado
    Irvine, Estados Unidos· Recrutamento
  • Southern California Clinical Research
    Código postal verificado
    Santa Ana, United States· Recrutamento
  • Children's Hospital Colorado
    Código postal verificado
    Aurora, Estados Unidos· Recrutamento
  • Children's National Hospital
    Código postal verificado
    Washington D.C., Estados Unidos· Recrutamento
  • Pediatric Skin Research
    Código postal verificado
    Miami, Estados Unidos· Recrutamento
  • Endeavor Health Clinical Operations
    Código postal verificado
    Skokie, United States· Recrutamento
  • Dawes Fretzin Clinical Research Group, LLC
    Código postal verificado
    Indianápolis, Estados Unidos· Recrutamento
  • Kindred Hair and Skin Center
    Código postal verificado
    Marriottsville, United States· Ainda não recrutando
  • Michigan Dermatology Institute
    Código postal verificado
    Waterford, United States· Recrutamento
  • Ear, Nose & Throat Consultants, LLC
    Código postal verificado
    Omaha, Estados Unidos· Recrutamento
  • Skin Specialists, PC dba Schlessinger MD
    Código postal verificado
    Omaha, Estados Unidos· Recrutamento
  • University of New Mexico Health Sciences Center
    Código postal verificado
    Albuquerque, United States· Recrutamento

Perguntas frequentes

What is ritlecitinib?

Ritlecitinib is the name of the medicine being tested in this study. It's a type of drug that aims to help with hair loss caused by severe alopecia areata.

Quem pode participar deste estudo?

Only children who have already taken part in Pfizer's previous alopecia areata studies (B7981027 or B7981031) can join this study.

Quanto tempo durará o estudo?

The study will last for up to three years (36 months).

Will I have to take daily medicine?

Yes, all participants in this study will take the study medicine, ritlecitinib, as a capsule once a day.

What kind of visits will I have?

You will have regular visits to the study clinic (17 over three years) and monthly phone calls with the study team.

Como saber mais

Pfizer CT.gov Call Center

clinicaltrials.gov_inquiries@pfizer.com 1-800-718-1021 Registro oficial do julgamento

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

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