A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
This research study is investigating a new medication called inebilizumab for people with a condition known as IgG4-Related Disease (IgG4-RD). The main goal is to find out if inebilizumab can help prevent sudden worsenings or 'flares' of IgG4-RD and if it is safe for patients. Participants will receive either inebilizumab or a dummy treatment (placebo) through a drip. They will also receive a short course of steroids at the start. Researchers will carefully monitor participants for any flares and how they respond to treatment. The study also includes an optional longer-term treatment phase and a safety follow-up period.
At a glance
What is this study about?
IgG4-Related Disease (IgG4-RD) is a condition where your body's immune system mistakenly attacks its own organs and tissues. This can lead to swelling and damage in various parts of the body. We don't fully understand why this happens, but it can affect many different organs. Sometimes, the disease can suddenly get worse, which is called a 'flare'. Managing these flares and preventing them from happening is an important part of living with IgG4-RD.
This study is testing a new medicine called inebilizumab. Researchers want to see if this medicine can help prevent these flares in people with IgG4-RD. They also want to make sure the medicine is safe. By comparing inebilizumab with a dummy treatment (placebo), the study aims to get a clear picture of how effective and safe this new medicine might be.
Finding new ways to manage IgG4-RD is really important for people living with this condition. If inebilizumab proves to be effective, it could offer a new option to help people avoid flares and improve their quality of life. This research is a crucial step in understanding more about this medication.
Key takeaways
- This study investigates a new treatment, inebilizumab, for IgG4-Related Disease.
- The main goal is to see if inebilizumab can prevent disease flares and is safe.
- Participants will receive either inebilizumab or a placebo through an IV drip.
- Initial steroid treatment will be given to all participants.
- The study includes optional long-term treatment and safety monitoring.
- Participation involves regular visits and careful health monitoring.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. You need to have a clear diagnosis of IgG4-Related Disease (IgG4-RD) that meets specific medical standards. You should also have had a recent flare-up of your IgG4-RD that requires you to be on steroid treatment, or to restart it.
Your IgG4-RD must have affected at least two different organs in your body at some point. For women who could become pregnant, or men with a female partner who could become pregnant, effective birth control methods must be used throughout the study and for a period afterwards.
There are also some reasons why you might not be able to join. For example, if you've had an organ transplant or have certain immune system problems. If you have active cancer or a history of cancer within the last 10 years (with some specific exceptions for certain skin, cervical, or prostate cancers), you wouldn't be able to participate. You also can't have received certain types of strong immune-modifying drugs or B-cell targeting therapies within a few months before the study starts, or had certain infections like active tuberculosis or hepatitis. Finally, people with severe kidney problems or those who have had a live vaccine recently would not be suitable.
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.
- Are you 18 years old or older?
- Do you have a confirmed diagnosis of IgG4-Related Disease?
- Have you recently had an IgG4-Related Disease flare-up and are on (or starting) steroids?
- Has your IgG4-Related Disease affected at least two organs?
- Do you (or your partner) use effective contraception, if needed?
- Do you have any serious existing medical conditions like active cancer or certain infections?
What does participation involve?
If you decide to take part, the first step is a screening period, which can last up to 28 days. During this time, doctors will check if you're suitable for the study. If you qualify, you'll be randomly assigned to one of two groups: one will receive the study medication (inebilizumab) and the other will receive a dummy treatment (placebo). Both will be given through a drip (IV).
At the start, you'll also receive a course of steroid medication that will be gradually reduced. During the main part of the study, which lasts for 52 weeks, you'll have regular visits where you'll receive your assigned treatment and be monitored closely. If you experience any disease flares, they will be treated by the medical team.
After the main study, there's an optional extra 3-year period where eligible participants can receive the study medication openly. Everyone in the study will also have a safety follow-up period for up to 730 days to make sure there are no long-term problems. The total time you could be involved, including all parts, could be up to 2273 days (about 6 years and 3 months).
Potential risks and benefits
Locations (72)
- Viela Bio Investigative SiteVerified postcodePalo Alto, United States
- Viela Bio Investigative SiteVerified postcodeAtlanta, United States
- Viela Bio Investigative SiteVerified postcodeBaltimore, United States
- Viela Bio Investigative SiteVerified postcodeBoston, United States
- Viela Bio Investigative SiteVerified postcodeBuenos Aires, Argentina
- Viela Bio Investigative SiteVerified postcodeMendoza, Argentina
- Viela Bio Investigative SiteVerified postcodeAuchenflower, Australia
- Viela Bio Investigative SiteVerified postcodeAdelaide, Australia
- Viela Bio Investigative SiteVerified postcodeFitzroy, Australia
- Viela Bio Investigative SiteVerified postcodeSherbrooke, Canada
- Viela Bio Investigative Site 1Verified postcodeToronto, Canada
- Viela Bio Investigative Site 2Verified postcodeToronto, Canada
Common questions
What is IgG4-Related Disease?
It's a condition where your immune system attacks your own organs, causing swelling and damage. It can affect many different parts of your body.
What is a 'flare'?
A flare is when your IgG4-Related Disease suddenly gets worse, causing new or more severe symptoms.
What is a placebo?
A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers see if the actual medicine is working better than no treatment.
Will I know if I'm getting the real medicine or the placebo?
During the main part of the study, neither you nor your study doctor will know if you're receiving the real medicine or the placebo. This helps make the study results fair.
How long will I be in the study?
Your participation could last up to about 400 days for the main part, but if you choose to join the optional longer treatment and safety follow-up, it could be up to 6 years and 3 months in total.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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