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.
במבט חטוף
על מה המחקר הזה?
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.
נקודות עיקריות
- 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.
מי עשוי להיות זכאי?
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.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- האם אתה בין גיל 18 ל-80?
- Has a skin doctor confirmed you have HS, and have you had it for at least 6 months?
- Do you currently have at least 6 active HS lumps or pus-filled spots?
- Does your HS affect at least two different body areas, with at least one being quite severe?
- Have you avoided surgery or laser treatment for HS in the last few weeks?
- Have you recently stopped or changed certain HS medications (like strong antibiotics or biologics) as per the study rules?
מה כרוך בהשתתפות?
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.
סיכונים ותועלות פוטנציאליים
Locations (72)
- USA001מיקוד מאומתפניקס, ארצות הברית
- USA007מיקוד מאומתסקרמנטו, ארצות הברית
- USA026מיקוד מאומתCoral Gables, United States
- USA027מיקוד מאומתHollywood, United States
- USA021מיקוד מאומתMargate, United States
- USA018מיקוד מאומתמיאמי, ארצות הברית
- USA025מיקוד מאומתאוקלה, ארצות הברית
- USA004מיקוד מאומתטמפה, ארצות הברית
- USA010מיקוד מאומתWeston, United States
- USA028מיקוד מאומתאטלנטה, ארצות הברית
- USA011מיקוד מאומתSandy Springs, United States
- USA003מיקוד מאומתPlainfield, United States
שאלות נפוצות
What is hidradenitis suppurativa (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.
מה המשמעות של 'פלצבו'?
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.
האם אדע אם אני מקבל את התרופה האמיתית או את הפלצבו?
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.
האם אני יכול לעזוב את המחקר בכל עת?
Yes, taking part is voluntary, and you can withdraw from the study at any time, for any reason, without affecting your regular medical care.
מה מטרת המחקר הזה?
The main purpose is to see if brensocatib is safe and effective in treating moderate to severe HS compared to a placebo.
כיצד לגלות עוד
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
דיון
דיון קהילתי
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