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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.

Auf einen Blick

Status
Aktiv, aber nicht rekrutierend
Phase
PHASE2
Sponsor
Insmed Incorporated
Einschreibeziel
214
Starten
16. Dez 2024
Geschätzte Fertigstellung
17 Nov 2026
Hidradenitis Suppurativa

Worum geht es in dieser Studie?

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.

Wichtige Erkenntnisse

  • 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.

Wer könnte berechtigt sein?

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.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. Sind Sie zwischen 18 und 80 Jahre alt?
  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?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

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.

Potenzielle Risiken und Vorteile

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
    Verifizierte Postleitzahl
    Phoenix, Vereinigte Staaten
  • USA007
    Verifizierte Postleitzahl
    Sacramento, Vereinigte Staaten
  • USA026
    Verifizierte Postleitzahl
    Coral Gables, Vereinigte Staaten
  • USA027
    Verifizierte Postleitzahl
    Hollywood, Vereinigte Staaten
  • USA021
    Verifizierte Postleitzahl
    Margate, Vereinigte Staaten
  • USA018
    Verifizierte Postleitzahl
    Miami, Vereinigte Staaten
  • USA025
    Verifizierte Postleitzahl
    Ocala, United States
  • USA004
    Verifizierte Postleitzahl
    Tampa, Vereinigte Staaten
  • USA010
    Verifizierte Postleitzahl
    Weston, United States
  • USA028
    Verifizierte Postleitzahl
    Atlanta, Vereinigte Staaten
  • USA011
    Verifizierte Postleitzahl
    Sandy Springs, Vereinigte Staaten
  • USA003
    Verifizierte Postleitzahl
    Plainfield, United States

Häufige Fragen

Was ist 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.

Was bedeutet 'Placebo'?

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.

Werde ich wissen, ob ich das echte Medikament oder das Placebo erhalte?

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.

Kann ich die Studie jederzeit verlassen?

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

Was ist der Zweck dieser Studie?

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

Wie Sie mehr erfahren können

Offizielles Gerichtsprotokoll

Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.

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