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.
Överblick
Vad handlar denna studie om?
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.
Viktiga punkter
- 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.
- Du kan sluta delta när som helst.
Vem kan vara berättigad?
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.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Är du 18 år eller äldre?
- Do you weigh at least 40 kilograms (6 stone 4 pounds)?
- Have you been diagnosed with EGPA for at least six months?
- Does your EGPA keep coming back or hasn't responded well to previous treatments?
- Are you taking a stable dose (7.5mg-50mg daily) of prednisolone or equivalent?
- Are you prepared to use highly effective contraception if you are a woman who could become pregnant?
Vad innebär deltagande?
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.
Potentiella risker och fördelar
Platser (63)
- GSK UndersökningsplatsVerifierat postnummerDenver, USA
- GSK UndersökningsplatsVerifierat postnummerGainesville, USA
- GSK UndersökningsplatsVerifierat postnummerRochester, USA
- GSK UndersökningsplatsVerifierat postnummerNew York, USA
- GSK UndersökningsplatsVerifierat postnummerCharlotte, USA
- GSK UndersökningsplatsVerifierat postnummerPittsburgh, USA
- GSK UndersökningsplatsVerifierat postnummerLa Plata, Argentina
- GSK UndersökningsplatsVerifierat postnummerSan Miguel de Tucumán, Argentina
- GSK UndersökningsplatsVerifierat postnummerGraz, Österrike
- GSK UndersökningsplatsVerifierat postnummerSanto André, Brazil
- GSK UndersökningsplatsVerifierat postnummerSão Paulo, Brasilien
- GSK UndersökningsplatsVerifierat postnummerToronto, Kanada
Vanliga frågor
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.
Kommer jag att veta vilken medicin jag får?
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.
Hur länge kommer studien att pågå?
The study team will tell you the exact duration, including how long you'll be taking the study medicine and the follow-up period.
Hur du får reda på mer
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
Diskussion
Gemenskapsdiskussion
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