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RecrutementPhase II et Phase III (Intégrée)Interventionnel

Lunsayil LTE : Un essai d'extension évaluant le traitement à long terme par spesolimab chez les patients atteints de Hidradenitis Suppurativa (HS)

This study, called Lunsayil LTE, is an important research project for people with a skin condition called Hidradenitis Suppurativa (HS). HS causes painful lumps and boils, and can be very challenging. This study is testing a new medicine called spesolimab to see if it can help. It's an ‘extension’ study, which means it builds on earlier research. Researchers are particularly interested in understanding the long-term effects of spesolimab, especially focusing on any side effects that might come up while people are taking the medicine. They want to know if it's safe and how well it helps over a longer period. Both men and women aged 18 and over can potentially take part.

En un coup d'œil

Statut
Recrutement
Phase
Phase II et Phase III (Intégrée)
Sponsor
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Objectif d'inscription
99
Démarrer
03 Jun 2024

De quoi parle cette étude ?

Imagine a special research project looking at a new way to treat a skin condition called Hidradenitis Suppurativa, or HS. HS causes painful, pus-filled lumps under the skin, often in areas where skin rubs together, like armpits or groin. It can be a very uncomfortable condition and difficult to manage.

This particular study is called Lunsayil LTE, and it's trying to understand more about a medicine called spesolimab. Think of it as a deeper dive into how this medicine works over a longer time. Researchers want to see if spesolimab can help reduce the symptoms of HS and improve people's quality of life. An important part of this research is carefully watching for any side effects people might experience while taking the medicine.

This study is an 'extension' study. This often means that some participants might have already been part of an earlier study looking at spesolimab. Now, the researchers want to continue to follow these patients, and possibly new ones, for a longer period to get a more complete picture of spesolimab's safety and how well it works when used for an extended time. This helps doctors and scientists understand if it could be a good long-term treatment option for HS.

Points clés

  • This study is testing a new medicine, spesolimab, for Hidradenitis Suppurativa (HS).
  • It's an 'extension' study, focusing on the long-term safety and effects of the treatment.
  • Participants must be 18 years or older, both men and women are included.
  • You might receive the active medicine or a placebo.
  • Close monitoring for side effects is a key part of the study.
  • La participation est volontaire, et vous pouvez vous retirer à tout moment.

Qui peut être éligible ?

To be considered for this study, you need to be at least 18 years old. There's no upper age limit, meaning older adults can also take part if they meet other requirements.

Both men and women are welcome to participate in this study. The researchers want to understand how the treatment works for everyone, regardless of gender.

Because this is an 'extension' study for Hidradenitis Suppurativa, it's likely that participants will have a confirmed diagnosis of HS. There might be other specific health requirements or conditions that would make someone suitable or unsuitable, which a doctor involved in the study would discuss with you in detail.

Cet étude pourrait-elle vous convenir ?

Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.

  1. Avez-vous 18 ans ou plus ?
  2. Do you have a diagnosis of Hidradenitis Suppurativa (HS)?
  3. Êtes-vous capable d'assister à des rendez-vous d'étude réguliers ?
  4. Are you comfortable with the possibility of receiving a placebo?
  5. Are you willing to have your health closely monitored?
Répondez à chaque question pour voir votre résultat.

En quoi consiste la participation ?

If you decide to take part in this study, you might receive either the study medicine, spesolimab, or a placebo. A placebo looks just like the real medicine but contains no active drug. This helps researchers understand if the medicine itself is causing any changes. You won't know if you're getting the active medicine or the placebo, and neither will your study doctor, until the study is over.

Taking part will involve regular visits to the study clinic. During these visits, the study team will carry out various checks and assessments. This might include physical exams, blood tests, and questions about your health and how you're feeling. They will also keep a close eye on your HS symptoms and any side effects you might experience.

The total length of time you'd be involved in the study can vary, but because it’s an 'extension' study focused on long-term effects, it will likely involve a commitment over several months, or potentially even longer. There will also be follow-up appointments after you've finished taking the study medicine to ensure your health is alright.

Risques et avantages potentiels

Participating in a clinical trial may offer potential benefits, such as receiving a new investigational treatment for your HS that is not yet widely available, and having very close monitoring of your health. However, there are also potential risks; you might experience side effects from the study medicine, or the medicine might not be effective for you. You will also need to commit your time for study visits. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Emplacements (14)

Certains emplacements de site sont approximatifs. Nous améliorons cela — veuillez vérifier avec l'équipe d'essai avant de vous déplacer.
  • —
    Non vérifié
    Espagne
  • —
    Non vérifié
    Slovaquie
  • —
    Non vérifié
    France
  • —
    Non vérifié
    Finlande
  • —
    Non vérifié
    Bulgarie
  • —
    Non vérifié
    Pologne
  • —
    Non vérifié
    Belgique
  • —
    Non vérifié
    Tchéquie
  • —
    Non vérifié
    Grèce
  • —
    Non vérifié
    Danemark
  • —
    Non vérifié
    Italie
  • —
    Non vérifié
    Lituanie

Questions fréquentes

Qu'est-ce que l'Hidradénite Suppurée (HS) ?

HS is a long-term skin condition that causes painful lumps, boils, and abscesses, often in areas where skin rubs together.

What is spesolimab?

Spesolimab is an investigational medicine being tested to see if it can help treat HS symptoms.

What is an 'extension' trial?

An extension trial means it follows earlier research, looking to understand how the medicine works over a longer period, especially regarding safety.

Will I definitely get the active medicine?

No, you might receive the active medicine or a 'placebo' (a dummy medicine) to help researchers understand if the drug is truly effective.

What does 'treatment emergent adverse events' mean?

This refers to any health problems or side effects that happen to a patient while they are part of the study and taking the medicine.

Comment en savoir plus

Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.

Intéressé à participer ?

Inscrivez votre intérêt

Partagez vos coordonnées et l'équipe de recherche pour "Lunsayil LTE: An extension trial assessing long-term spesoli… vous contactera si vous êtes éligible. Consultez toujours votre médecin avant d'accepter de participer.

Discussion

Discussion communautaire

Propulsé par notre forum à community.patient.info. Veuillez être respectueux — ceci n'est pas un avis médical.