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A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)

This research study is looking at a new medicine called brensocatib for adults who have hidradenitis suppurativa (HS). HS is a long-term skin condition causing painful lumps and abscesses. We want to find out if brensocatib can help reduce these symptoms and if it's safe to use. Some participants will receive the new medicine, while others will receive a placebo (a dummy medicine with no active ingredients). This helps us compare the effects directly. The study is particularly for those with moderate to severe HS that has been present for at least six months. This type of research is an important step in finding new and better treatments for HS.

Em resumo

Status
Ativo, mas não recrutando
Fase
FASE2
Patrocinador
Insmed Incorporated
Meta de inscrição
214
Iniciar
16 Dez 2024
Conclusão estimada
17 Nov 2026
Hidradenitis Suppurativa

Sobre o que é este estudo?

This study is about a new medicine called brensocatib and how it might help people with hidradenitis suppurativa, often called HS. HS is a long-term skin condition that causes painful, inflamed lumps and abscesses, mainly in areas where skin rubs together, like the armpits or groin. These can sometimes burst and form tunnels under the skin, which can be very uncomfortable.

The main goal of this research is to see if brensocatib works better than a placebo, which is a dummy medicine that looks the same but contains no active ingredients. Giving some participants the active medicine and some the placebo helps doctors understand if any changes or improvements are truly due to brensocatib or if they might happen naturally. We also want to make sure the medicine is safe to use and doesn't cause too many side effects.

Finding new ways to treat HS is really important because it can be a challenging condition to live with. This study could help us learn more about brensocatib and whether it could become a useful treatment option for people with moderate to severe HS in the future. Studies like this are how new treatments are discovered and approved to help patients.

Pontos principais

  • This study is testing a new medicine for moderate to severe HS.
  • It aims to see if brensocatib is safe and effective compared to a dummy pill (placebo).
  • Participation involves regular clinic visits and close monitoring of your health.
  • You might receive the active medicine or a placebo, and you won't know which one.
  • The study could help find new treatments for HS. You can leave the study at any time.

Quem pode ser elegível?

To join this study, you need to be an adult between 18 and 80 years old, and you must have hidradenitis suppurativa (HS) that a skin doctor has confirmed. Your HS needs to have been present for at least six months and be considered moderate to severe, meaning you have at least six active painful lumps or pus-filled spots.

Your HS also needs to affect at least two different body areas, and at least one of these areas should be quite severe (what doctors call Hurley Stage II or III). You won't be able to join if you have many draining tunnels (20 or more) or if you've had surgery or laser treatment for your HS recently.

There are also some medical conditions and recent treatments that might prevent you from joining, such as certain blood conditions, active liver disease, or if you've recently taken certain strong antibiotics or other medicines for HS. This is to make sure the study is safe for everyone involved and that the results are clear.

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 entre 18 e 80 anos?
  2. Has a skin doctor confirmed you have HS, and have you had it for at least 6 months?
  3. Do you currently have at least 6 active HS lumps or pus-filled spots?
  4. Does your HS affect at least two different body areas, with at least one being quite severe?
  5. Have you avoided surgery or laser treatment for HS in the last few weeks?
  6. Have you recently stopped or changed certain HS medications (like strong antibiotics or biologics) as per the study rules?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to take part, you'll be assigned either to receive the study medicine (brensocatib) or a dummy medicine (placebo). You won't know which one you're getting, and neither will your study doctor. You'll need to visit the clinic regularly for check-ups, where the study team will monitor your HS, take blood samples, and ask about your health and any side effects. You might also need to keep a diary of your symptoms. The study will involve taking the medicine for a set period, followed by follow-up visits. The total duration of your involvement in the study will be explained in detail by the study team.

Riscos e benefícios potenciais

Taking part in any medical study has potential benefits and risks. A potential benefit could be that the new medicine helps improve your HS symptoms. Even if you receive the placebo, your condition will be closely monitored by medical professionals. On the other hand, there might be side effects from the medicine, or it might not help your HS. All potential risks will be fully explained to you before you decide to join. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (72)

  • USA001
    Código postal verificado
    Phoenix, Estados Unidos
  • USA007
    Código postal verificado
    Sacramento, Estados Unidos
  • USA026
    Código postal verificado
    Coral Gables, Estados Unidos
  • USA027
    Código postal verificado
    Hollywood, Estados Unidos
  • USA021
    Código postal verificado
    Margate, United States
  • USA018
    Código postal verificado
    Miami, Estados Unidos
  • USA025
    Código postal verificado
    Ocala, Estados Unidos
  • USA004
    Código postal verificado
    Tampa, Estados Unidos
  • USA010
    Código postal verificado
    Weston, United States
  • USA028
    Código postal verificado
    Atlanta, Estados Unidos
  • USA011
    Código postal verificado
    Sandy Springs, United States
  • USA003
    Código postal verificado
    Plainfield, United States

Perguntas frequentes

O que é hidradenite supurativa (HS)?

HS is a long-term skin condition that causes painful lumps, abscesses, and sometimes tunnels under the skin, usually in areas like the armpits, groin, or under the breasts.

What does 'placebo' mean?

A placebo is a dummy medicine that looks like the real study drug but contains no active ingredients. It helps researchers see if the real medicine has a genuine effect.

Saberei se estou recebendo o medicamento real ou o placebo?

No, during the study, neither you nor the doctors will know whether you are receiving brensocatib or the placebo. This is to keep the study fair and unbiased.

Posso sair do estudo a qualquer momento?

Yes, taking part is voluntary, and you can withdraw from the study at any time, for any reason, without affecting your regular medical care.

What is the purpose of this study?

The main purpose is to see if brensocatib is safe and effective in treating moderate to severe HS compared to a placebo.

Como saber mais

Registro oficial do julgamento

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.