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RecrutamentoFASE3INTERVENCIONISTA

A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa

This study is investigating a new medicine called Bimekizumab for younger people, specifically children and teenagers aged 9 to 17, who have hidradenitis suppurativa (HS). HS is a chronic skin condition causing painful bumps and boils. Researchers want to understand how Bimekizumab moves through the body of these young patients and how safe it is for them. This is a late-stage study, meaning the medicine has already been through earlier testing. The aim is to see if Bimekizumab could be a new treatment option for young people living with moderate to severe HS.

Em resumo

Status
Recrutamento
Fase
FASE3
Patrocinador
UCB Biopharma SRL
Meta de inscrição
40
Iniciar
07 Apr 2025
Conclusão estimada
06 Mar 2029

Sobre o que é este estudo?

This study is designed to explore a new medicine called Bimekizumab for children and teenagers who have a skin condition called Hidradenitis Suppurativa (HS). HS causes painful lumps, boils, and sometimes tunnels under the skin, often in areas like the armpits or groin. It can be quite severe, and current treatments don't always work for everyone, especially younger patients.

The main goals of this study are twofold. Firstly, researchers want to understand how Bimekizumab behaves in the bodies of young people – how much medicine gets into the bloodstream, how long it stays there, and how it's handled by the body. This is important to ensure the right dose is given. Secondly, they want to check the safety of Bimekizumab for this age group. They will carefully monitor participants for any side effects or unwanted reactions.

By gathering this information, the study aims to see if Bimekizumab could become a safe and effective new treatment option for young people aged 9 to 17 living with moderate to severe HS. It's a phase 3 study, which means it’s a later stage of research, often done before a medicine can be considered for wider use.

Pontos principais

  • This study investigates a new medicine (Bimekizumab) for moderate to severe HS.
  • It's for children and teenagers aged 9-17.
  • The study will check how safe the medicine is and how it works in the body.
  • It's a Phase 3 study, meaning it's a late-stage test.
  • Participation involves regular clinic visits and close monitoring.
  • Você pode se retirar do estudo a qualquer momento.

Quem pode ser elegível?

This study is looking for young people aged 9 to 17 years old who have Hidradenitis Suppurativa (HS). To be considered, you must have been diagnosed with HS for at least six months and have moderate to severe HS with at least five inflamed bumps (abscesses or painful lumps). Your HS should affect at least two different body areas, with at least one area being moderately or severely affected (known as Hurley Stage II or III). You also need to weigh at least 30 kilograms (about 4 stone 10 pounds) and have tried a course of antibiotics for your HS that didn't work well enough.

There are also some reasons why you might not be able to join. For example, if you have more than 20 draining tunnels from your HS, or if you've already tried certain biologic medicines (like brodalumab, ixekizumab, or secukinumab) for HS and they didn't help at all. You also can't join if you've been in this study before or have taken Bimekizumab previously. Other reasons include a history of certain bowel conditions (like Inflammatory Bowel Disease), active or untreated tuberculosis, or ongoing serious infections.

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. Are you between 9 and 17 years old?
  2. Have you been diagnosed with HS for at least 6 months?
  3. Do you have moderate to severe HS affecting at least two body areas?
  4. Does your HS include at least 5 active bumps (abscesses or inflamed lumps)?
  5. Have you tried antibiotics for your HS that didn't work well enough?
  6. Do you weigh at least 30 kilograms (around 4 stone 10 pounds)?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to take part in this study, you will receive doses of Bimekizumab, likely given as an injection under the skin. You will have regular visits to the clinic where the study team will monitor your health, assess your HS, and check for any side effects. This will involve physical examinations, blood tests, and potentially other procedures to see how the medicine is working and how you are feeling. The study will involve a number of visits over a period that isn't fully detailed here, but will be explained to you by the study team. You'll need to follow specific instructions about other medicines you might be taking. The study team will provide all the necessary medication and care related to the trial.

Riscos e benefícios potenciais

Taking part in this study could potentially offer some benefits, such as access to a new medicine for your HS that isn't widely available yet, which might help improve your condition. However, there are also potential risks, as with any new medicine. Bimekizumab might cause side effects, which will be carefully explained to you by the study team. They will monitor you closely for any unwanted reactions. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Localizações (18)

  • Hs0006 50175
    Código postal verificado
    Phoenix, Estados Unidos· Recrutamento
  • Hs0006 50708
    Código postal verificado
    Roseville, United States· Recrutamento
  • Hs0006 50684
    Código postal verificado
    Sacramento, Estados Unidos· Ativo, mas não recrutando
  • Hs0006 50707
    Código postal verificado
    Washington D.C., Estados Unidos· Recrutamento
  • Hs0006 50199
    Código postal verificado
    Miami, Estados Unidos· Recrutamento
  • Hs0006 50178
    Código postal verificado
    Clarkston, United States· Recrutamento
  • Hs0006 50710
    Apenas cidade
    Fort Gratiot, United States· Recrutamento
  • Hs0006 50711
    Código postal verificado
    Troy, Estados Unidos· Recrutamento
  • Hs0006 50712
    Código postal verificado
    Nova Iorque, Estados Unidos· Recrutamento
  • Hs0006 50706
    Código postal verificado
    Chapel Hill, United States· Recrutamento
  • Hs0006 50202
    Código postal verificado
    Fairborn, United States· Recrutamento
  • Hs0006 50201
    Código postal verificado
    Arlington, United States· Recrutamento

Perguntas frequentes

O que é Hidradenite Supurativa (HS)?

HS is a long-term skin condition that causes painful, inflamed bumps, boils, and sometimes tunnels to form under the skin, often in places where skin rubs together like armpits or groin.

What is Bimekizumab?

Bimekizumab is a new medication being tested. It's a type of 'biologic' medicine that targets specific parts of the immune system that cause inflammation in conditions like HS.

O que significa 'Fase 3' para um estudo?

Phase 3 means this is a later stage of testing. The medicine has already been studied for safety and basic effectiveness, and now it's being tested in a larger group of people to confirm its benefits and risks.

Eu terei que pagar para participar do estudo?

No, all study-related treatments and assessments are provided free of charge if you qualify and choose to participate.

Can I continue my usual HS treatment while in the study?

Some existing treatments might need to be stopped or changed during the study. The study team will discuss this with you and explain which medications are allowed or not allowed.

Como saber mais

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