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Aktiv, aber nicht rekrutierendPHASE3INTERVENTIONELL

Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)

This research study is for adults who have a rare and sometimes serious condition called Eosinophilic Granulomatosis with Polyangiitis (EGPA). If you have EGPA that keeps coming back or hasn't responded well to other treatments, this study might be for you. We are comparing two medications, Depemokimab and Mepolizumab, to see which one works better and is safer. Both medicines are given while you continue your usualEGPA care. The aim is to find effective ways to manage EGPA and improve people's lives.

Auf einen Blick

Status
Aktiv, aber nicht rekrutierend
Phase
PHASE3
Sponsor
GlaxoSmithKline
Einschreibeziel
163
Starten
14. Juli 2022
Geschätzte Fertigstellung
27 Oct 2026

Worum geht es in dieser Studie?

This study is looking closely at a condition called Eosinophilic Granulomatosis with Polyangiitis, or EGPA. It's a rare illness where your immune system mistakenly attacks healthy tissues, causing inflammation in different parts of your body. This can lead to problems like asthma, nerve damage, rashes, and issues with your heart or lungs.

We want to find out if new treatments can help people with EGPA whose condition keeps coming back or hasn't improved with other medicines. The study is comparing two drugs, Depemokimab and Mepolizumab, to see which one is more effective and has fewer side effects. Both of these drugs are given alongside the standard treatments you might already be receiving for EGPA.

By taking part, you would help doctors and scientists understand EGPA better and potentially discover new ways to manage the condition. This could lead to a better quality of life for people living with EGPA in the future.

Wichtige Erkenntnisse

  • This study is for adults with EGPA that is relapsing or difficult to treat.
  • It compares two potential new treatments, Depemokimab and Mepolizumab.
  • Participants will continue their usual EGPA care alongside the study medicine.
  • It aims to find safer and more effective ways to manage EGPA.
  • Participation involves regular check-ups and assessments.
  • Sie können die Teilnahme jederzeit beenden.

Wer könnte berechtigt sein?

To join this study, you need to be an adult (18 years or older) and weigh at least 40 kilograms (about 6 stone 4 pounds). You must have a clear diagnosis of EGPA that has been present for at least six months, and your EGPA must either keep coming back or not respond well to current treatments.

You also need to be taking a stable dose of a specific steroid medicine (prednisolone or prednisone, between 7.5mg and 50mg per day) for at least four weeks before the study starts. If you're on other immune-suppressing medicines (but not cyclophosphamide), their dose also needs to be stable. If you are a woman who could become pregnant, you'll need to be using a very reliable form of contraception.

There are some reasons you might not be able to join. For example, if you have a different but similar condition called Granulomatosis with Polyangiitis (Wegener's) or Microscopic Polyangiitis, you wouldn't be able to take part. Also, if your EGPA is severely affecting your organs in a life-threatening way, you would not be eligible for this study.

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 18 Jahre alt oder älter?
  2. Do you weigh at least 40 kilograms (6 stone 4 pounds)?
  3. Have you been diagnosed with EGPA for at least six months?
  4. Does your EGPA keep coming back or hasn't responded well to previous treatments?
  5. Are you taking a stable dose (7.5mg-50mg daily) of prednisolone or equivalent?
  6. Are you prepared to use highly effective contraception if you are a woman who could become pregnant?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

The specific details of what taking part involves, such as the total number of visits, how often you'll need to attend the clinic, and for how long, would be fully explained by the study team. You would likely have regular appointments for check-ups, blood tests, and other assessments to monitor your health and how the treatment is working. The study involves taking either Depemokimab, Mepolizumab, or a placebo (a dummy medicine) alongside your current EGPA treatment. You wouldn't know which one you're receiving. There would also be follow-up appointments after you finish taking the study medicine. The total duration of your participation, from your first visit to your last follow-up, would be clearly outlined before you decide to join.

Potenzielle Risiken und Vorteile

Taking part in any medical study has potential benefits and risks. You might benefit from closer medical monitoring and possibly receive a new treatment that could help your EGPA. However, there's no guarantee the study medicine will help you, and you might experience side effects, just like with any medication. The study will thoroughly explain all known or potential risks before you decide to join. It is very important to remember that participating is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Standorte (63)

  • GSK Untersuchungsstelle
    Verifizierte Postleitzahl
    Denver, Vereinigte Staaten
  • GSK Untersuchungsstelle
    Verifizierte Postleitzahl
    Gainesville, Vereinigte Staaten
  • GSK Untersuchungsstelle
    Verifizierte Postleitzahl
    Rochester, Vereinigte Staaten
  • GSK Untersuchungsstelle
    Verifizierte Postleitzahl
    New York, Vereinigte Staaten
  • GSK Untersuchungsstelle
    Verifizierte Postleitzahl
    Charlotte, Vereinigte Staaten
  • GSK Untersuchungsstelle
    Verifizierte Postleitzahl
    Pittsburgh, United States
  • GSK Untersuchungsstelle
    Verifizierte Postleitzahl
    La Plata, Argentina
  • GSK Untersuchungsstelle
    Verifizierte Postleitzahl
    San Miguel de Tucumán, Argentina
  • GSK Untersuchungsstelle
    Verifizierte Postleitzahl
    Graz, Österreich
  • GSK Untersuchungsstelle
    Verifizierte Postleitzahl
    Santo André, Brazil
  • GSK Untersuchungsstelle
    Verifizierte Postleitzahl
    São Paulo, Brazil
  • GSK Untersuchungsstelle
    Verifizierte Postleitzahl
    Toronto, Kanada

Häufige Fragen

What is EGPA?

EGPA is a rare condition where your immune system causes inflammation in different parts of your body, often affecting the lungs, nerves, and heart.

What are Depemokimab and Mepolizumab?

These are the two medicines being tested in this study. They are types of treatments that aim to calm down the overactive immune system in EGPA.

Werde ich wissen, welches Medikament ich bekomme?

No, in this type of study, you won't know if you're receiving Depemokimab, Mepolizumab, or a placebo (a dummy medicine) to make sure the results are fair.

Will I still take my regular EGPA medication?

Yes, you will continue your usual EGPA treatment, including your steroid medicine, while taking part in this study.

Wie lange wird die Studie dauern?

The study team will tell you the exact duration, including how long you'll be taking the study medicine and the follow-up period.

Wie Sie mehr erfahren können

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

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