A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infections in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy ("PROTECT")
This study is called "PROTECT" and it's looking for a better way to prevent serious infections in people who have specific autoimmune or rheumatic conditions. These conditions are health problems where your body's immune system accidentally attacks itself. People in the study are also receiving a special treatment that can make them more likely to get infections. We want to find out if a medicine called Panzyga can help protect these patients from getting very sick. Some people in the study will get Panzyga, while others will receive a simple salt solution, all given through a drip. We will carefully compare how many serious infections happen in both groups to see if Panzyga is effective and safe.
At a glance
What is this study about?
This research study, known by its short name "PROTECT," is investigating a new approach to prevent serious infections. Many people with long-term conditions where their immune system mistakenly attacks their own body (called autoimmune or rheumatic conditions) need special treatments. These treatments, while helpful for their main condition, can sometimes weaken the immune system, making them more prone to getting infections.
The main goal of this study is to see if a medicine called Panzyga can help protect these vulnerable patients from serious infections. We want to understand if Panzyga can reduce the number of serious infections or even prevent deaths compared to not receiving this specific protection. To do this fairly, some patients will receive Panzyga through an intravenous drip, and others will receive a simple salt solution (a placebo) that looks exactly the same, given in the same way. Neither the patients nor their doctors will know who is getting which, to keep the results unbiased.
Throughout the study, we will be carefully tracking any major infections that occur, noting what type they are, how severe they become, and how long it takes for a person to recover. An independent group of expert doctors will review every potential infection to make sure the findings are consistent and accurate. By comparing the groups, we hope to find out if Panzyga is a safe and effective way to help people with these conditions stay healthier and avoid dangerous infections.
Key takeaways
- The study tests a medicine called Panzyga to prevent serious infections.
- It's for adults with certain autoimmune conditions and weakened immune systems.
- Participants receive either Panzyga or a non-active salt solution.
- Serious infections will be carefully monitored to see if Panzyga helps.
- An independent expert group will review all infection reports.
Who may be eligible?
To be part of this study, you need to be an adult, aged 18 or older. We are looking for both men and women to participate.
You would be a good fit if you have hypogammaglobulinemia, which means your body doesn't make enough antibodies to fight off infections. You also need to have an autoimmune or rheumatic condition, like rheumatoid arthritis or lupus, and be receiving, or about to receive, a specific type of treatment that can lower your immune system and make you more prone to infections. This treatment is often called B-cell depletion therapy.
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 condition where your body doesn't make enough antibodies (hypogammaglobulinemia)?
- Do you have an autoimmune or rheumatic condition (like arthritis or lupus)?
- Are you currently receiving, or about to receive, treatment that might weaken your immune system?
- Are you able to attend regular clinic appointments for infusions and check-ups?
What does participation involve?
If you decide to take part in this study, you will receive regular infusions (drips) of either the study medicine, Panzyga, or a salt solution. You will have regular appointments at the clinic for these infusions and for various health checks. These checks might include physical examinations to see how you are doing, and blood tests to monitor your health and how your body is responding to the treatment. The study team will keep a close eye on any infections you might develop and will record how severe they are and how long it takes for them to clear up. We will also monitor any side effects you might experience. The total duration of your participation, including how often you need to visit the clinic and for how long, will be clearly explained by the study team before you make any decisions.
Potential risks and benefits
Locations (8)
- —UnverifiedCzechia
- —UnverifiedLithuania
- —UnverifiedGreece
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedLatvia
- —UnverifiedBulgaria
- —UnverifiedItaly
Common questions
What is Panzyga?
Panzyga is a medicine given through a drip that aims to help your immune system fight off infections.
What is 'hypogammaglobulinemia'?
This means your body isn't making enough important immune proteins (antibodies) to protect against infections.
What are 'autoimmune or rheumatic conditions'?
These are conditions where your body's immune system mistakenly attacks your own tissues, like in rheumatoid arthritis or lupus.
Will I know if I'm getting the real medicine or the salt solution?
No, neither you nor your doctor will know during the study. This helps us get fair and accurate results.
What happens if I get an infection during the study?
The study team will carefully monitor any infections, assess their severity, and track your recovery, while ensuring you receive appropriate medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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