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RecrutementPharmacologie Humaine (Phase I) - AutreInterventionnel

Multiple Ascending Doses of BMS-986326 in Participants with Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, or Systemic Lupus Erythematosus

This early-stage study is looking into a new medication called BMS-986326. It's for adults (18 years and older) who have different types of lupus, specifically discoid lupus erythematosus (DLE), subacute cutaneous lupus erythematosus (SCLE), or systemic lupus erythematosus (SLE). The main goal is to understand how different amounts (doses) of this new medicine behave in the body and what effects it might have. This includes checking how safe it is and if there are any common side effects. This kind of study helps researchers learn important information about new medicines before they are tested in more people, moving towards finding potential new treatments for lupus. It's a key first step in developing new medicines.

En un coup d'œil

Statut
Recrutement
Phase
Pharmacologie Humaine (Phase I) - Autre
Sponsor
Bristol-Myers Squibb Services Unlimited Company
Objectif d'inscription
37
Démarrer
20 nov. 2023

De quoi parle cette étude ?

This research study is about exploring a new medication known as BMS-986326. It's designed for people living with certain types of lupus, including discoid lupus, subacute cutaneous lupus, or systemic lupus. Lupus is a long-term condition that can cause inflammation and a range of symptoms, often affecting the skin, joints, and internal organs. The aim of studies like these is to find new and more effective ways to manage the condition and improve the lives of those affected.

This particular study is in its very early stages, often called a 'Phase I' study. This means it's one of the first times the new medication is being tested in humans. The main purpose is to learn how the medicine works in the body, such as how it's absorbed, distributed, broken down, and removed. Researchers will be giving different doses of the medicine to see how the body reacts to each amount. This helps them find a safe and effective dose to study further.

By taking part, individuals would be helping scientists gather crucial information. This early insight into the medicine's safety and how it behaves in the human body is essential. It helps determine if the medicine is promising enough to continue into larger studies, ultimately moving closer to potentially offering another treatment option for people with lupus.

Points clés

  • Tests a new medicine (BMS-986326) for lupus.
  • Early stage study (Phase I) focused on safety and dose.
  • For adults (18+) with discoid, subacute cutaneous, or systemic lupus.
  • Involves regular clinic visits and health checks.
  • Participation helps advance lupus research.
  • Vous pouvez arrêter de participer à tout moment.

Qui peut être éligible ?

Pour participer à cette étude, vous devez être un adulte âgé de 18 ans ou plus. L'étude est ouverte aux hommes et aux femmes.

Crucially, you must have been diagnosed with one of the specific types of lupus the study is focusing on: discoid lupus erythematosus, subacute cutaneous lupus erythematosus, or systemic lupus erythematosus. Your medical team will be able to confirm whether your diagnosis fits these criteria.

There will also be other specific health requirements and medical checks to make sure the study is safe for you and that the results will be clear. For example, they will check your overall health and any other medications you might be taking. A doctor from the study team will discuss all these details with you.

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. Have you been diagnosed with discoid lupus, subacute cutaneous lupus, or systemic lupus?
  3. Are you able to attend regular appointments at a clinic?
  4. Are you willing to discuss your full medical history with the study team?
Répondez à chaque question pour voir votre résultat.

En quoi consiste la participation ?

If you decide to take part in this study, you would first have a screening visit to make sure you meet all the health requirements. If eligible, you would then receive the study medication, BMS-986326, at different dose levels. The study involves a series of visits to the clinic where doctors and nurses will monitor your health closely, perform examinations, take blood and urine samples, and ask about any new symptoms or side effects you might experience. They will be checking how the medicine affects your body and how your lupus symptoms change. The total duration of your participation, including follow-up appointments after you stop taking the study drug, would be clearly explained by the research team.

Risques et avantages potentiels

Participating in a study like this may offer some potential benefits, such as contributing to scientific knowledge and potentially helping develop new treatments for lupus. You will also receive careful medical monitoring from the study team throughout your participation. However, there are also potential risks involved. Since this is a new medication, not all side effects are known, and you might experience unexpected reactions. There's also no guarantee that the medication will improve your lupus. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Emplacements (6)

Certains emplacements de site sont approximatifs. Nous améliorons cela — veuillez vérifier avec l'équipe d'essai avant de vous déplacer.
  • —
    Non vérifié
    Pays-Bas
  • —
    Non vérifié
    Pologne
  • —
    Non vérifié
    Roumanie
  • —
    Non vérifié
    Allemagne
  • —
    Non vérifié
    Espagne
  • —
    Non vérifié
    Bulgarie

Questions fréquentes

What kind of new medicine is BMS-986326?

It's a new medicine being tested for people with lupus. We're in the early stages of understanding how it works in the body and if it's safe.

Qui peut participer à cette étude ?

Adults aged 18 and over who have been diagnosed with discoid lupus, subacute cutaneous lupus, or systemic lupus.

What is a 'Phase I' study?

It's an early stage where a new medicine is first tested in humans. The main goals are to check its safety and understand how the body handles different doses.

Will I definitely get the new medicine if I join?

Yes, if you meet the eligibility criteria and join this specific study, you would receive the investigational medicine BMS-986326.

What happens if I change my mind during the study?

You can leave the study at any time you wish, and it won't affect the medical care you receive for your lupus.

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 "Multiple Ascending Doses of BMS-986326 in Participants with … vous contactera si vous êtes éligible. Consultez toujours votre médecin avant d'accepter de participer.

Discussion

Discussion communautaire

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