A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
This study is testing a new drug called rilzabrutinib for adults who have a condition called IgG4-related disease. Doctors want to see if this new medication is better than a dummy pill (placebo) at stopping flare-ups and keeping the disease under control. The study will last for 52 weeks, with some patients getting rilzabrutinib and others getting the placebo. Researchers will carefully watch for any changes in the disease and any side effects. This is a "Phase 3" study, meaning it's a key step in deciding if the drug could become a new treatment option for people with IgG4-related disease.
At a glance
What is this study about?
Imagine your body's immune system, which usually fights off germs, sometimes gets confused and causes inflammation in different parts of your body. This is what happens in IgG4-related disease (IgG4-RD). It can affect various organs like the pancreas, kidneys, or tear glands. It's a long-term condition that can cause swelling, pain, and damage if not managed.
This study aims to find out if a new medication, rilzabrutinib, can help manage IgG4-RD. We want to see if it can reduce disease flare-ups and improve overall control of the condition. Many people with IgG4-RD currently take steroid medications (glucocorticoids) to help, but these can have side effects. This study investigates if rilzabrutinib can be a safer and more effective option, potentially allowing people to reduce their steroid use.
To make sure the study results are fair and accurate, some participants will receive the new medication, while others will receive a dummy pill (placebo). Neither you nor your study doctor will know which one you are getting. This helps us truly understand if rilzabrutinib is making a difference.
Key takeaways
- Tests a new drug (rilzabrutinib) for adults with IgG4-related disease.
- Compares the new drug to a dummy pill (placebo) for 52 weeks.
- Aims to see if the drug reduces flare-ups and controls the disease.
- Requires regular clinic visits and health checks.
- You might need to adjust your current steroid medication.
- Your health will be closely monitored throughout.
Who may be eligible?
To join this study, you must be an adult (18 years or older) and have a clear diagnosis of IgG4-related disease. Your disease needs to be active at the time you start the study in at least one part of your body (not just your lymph nodes). You also need to be willing to gradually reduce any steroid medication you might be taking once you start the study drug, and comfortable having scans like CT or MRI to check on your disease.
There are some reasons why you wouldn't be able to join. For example, if you have a specific type of fibrosis (scar tissue buildup) as your only symptom, or if you've had certain types of cancer in the last five years. People with known problems with their immune system are also not able to participate. The study team will review all your medical information carefully to see if this study is right for you.
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?
- Is your IgG4-related disease currently active in at least one organ?
- Are you willing to gradually reduce your steroid medication if you are taking it?
- Are you comfortable with having regular medical scans (e.g., CT, MRI)?
What does participation involve?
If you join this study, you'll be involved for about 60 weeks in total. This includes a short screening period (4-6 weeks) to make sure you're a good fit. After that, you'll be in the main treatment part for 52 weeks, where you'll be taking either the study medication or the dummy pill. During this time, you'll attend about 16 visits to the clinic so the doctors can check on you and your condition. After the 52 weeks, there will be a 2-week follow-up period. There's also an option to continue in an 'Open-Label Extension' part of the study for an additional 108 weeks, which would involve about 9 more visits, if that's suitable for you.
Potential risks and benefits
Locations (76)
- Kaiser Permanente - Fontana Medical Center- Site Number : 8400015Verified postcodeFontana, United States· Recruiting
- San Jose Clinical Trials- Site Number : 8400016Verified postcodeSan Jose, United States· Recruiting
- Solace Clinical Research - Tustin- Site Number : 8400020Verified postcodeTustin, United States· Recruiting
- Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400002Verified postcodeMargate, United States· Recruiting
- Schiff Center for Liver Diseases- Site Number : 8400010Verified postcodeMiami, United States· Recruiting
- Vitalia Medical Research - Margate- Site Number : 8400025Verified postcodePalm Beach Gardens, United States· Recruiting
- Emory University School of Medicine - Atlanta- Site Number : 8400013Verified postcodeAtlanta, United States· Recruiting
- Primeway Clinical Research- Site Number : 8400019Verified postcodeFayetteville, United States· Recruiting
- Massachusetts General Hospital- Site Number : 8400008Verified postcodeBoston, United States· Recruiting
- Mayo Clinic in Rochester - Minnesota- Site Number : 8400017Verified postcodeRochester, United States· Recruiting
- Cleveland Clinic - Cleveland- Site Number : 8400001Verified postcodeCleveland, United States· Recruiting
- Ohio State University Wexner Medical Center- Site Number : 8400024Verified postcodeColumbus, United States· Recruiting
Common questions
What is IgG4-related disease?
It's a condition where your immune system causes inflammation and can affect different organs in your body, leading to swelling and pain.
What is a 'placebo'?
A placebo is a dummy pill that looks just like the study medication but contains no active drug. It helps researchers fairly compare the new treatment.
Will I know if I'm getting the study drug or the placebo?
No, neither you nor your doctor will know during the main 52-week treatment period. This is called 'double-blind' and makes the study results more reliable.
How often will I need to visit the clinic?
You'll have about 16 visits over the 52-week main treatment period, plus initial screening and a follow-up visit.
Can I stop participating in the study if I want to?
Yes, absolutely. You have the right to withdraw from the study at any time without giving a reason, and it won't affect your medical care.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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