All studies
Active not recruitingPHASE3INTERVENTIONAL

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.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
GlaxoSmithKline
Enrolment target
163
Start
14 Jul 2022
Estimated completion
27 Oct 2026

What is this study about?

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.

Key takeaways

  • 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.
  • You can stop participating at any time.

Who may be eligible?

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.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  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?
Answer every question to see your result.

What does participation involve?

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.

Potential risks and benefits

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.

Locations (76)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • GSK Investigational Site
    Verified postcode
    Denver, United States
  • GSK Investigational Site
    Verified postcode
    Gainesville, United States
  • GSK Investigational Site
    Verified postcode
    Rochester, United States
  • GSK Investigational Site
    Verified postcode
    New York, United States
  • GSK Investigational Site
    Verified postcode
    Charlotte, United States
  • GSK Investigational Site
    Verified postcode
    Tulsa, United States
  • GSK Investigational Site
    Verified postcode
    Philadelphia, United States
  • GSK Investigational Site
    Verified postcode
    Pittsburgh, United States
  • GSK Investigational Site
    Verified postcode
    Norfolk, United States
  • GSK Investigational Site
    Verified postcode
    La Plata, Argentina
  • GSK Investigational Site
    Verified postcode
    San Miguel de Tucumán, Argentina
  • GSK Investigational Site
    Verified postcode
    Graz, Austria

Common questions

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.

Will I know which medicine I'm getting?

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.

How long will the study last?

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

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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