A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
This study is looking into a new medicine, sibeprenlimab, for adults with Sjögren's disease. It's a 'Phase 2' trial, meaning we're checking its effectiveness and safety. Participants will have the medicine injected under the skin every four weeks, on top of their current treatments. Some will receive the active medicine, while others will get a placebo (a dummy medicine) to compare the effects. The main goal is to see if sibeprenlimab helps reduce the problems caused by Sjögren's disease after 28 weeks. We're also checking how it affects everyday symptoms reported by patients. About 80 people will take part, with half getting the new medicine and half getting the placebo.
At a glance
What is this study about?
This study is a research project aiming to find out if a new medicine called sibeprenlimab can help people with Sjögren's disease. Sjögren's disease is a long-term condition that mainly affects your moisture-producing glands, leading to symptoms like dry eyes and dry mouth, but it can also affect other parts of your body, causing tiredness and joint pain. The main purpose of this study is to see if sibeprenlimab can reduce these symptoms and improve how people feel, compared to a dummy medicine (called a placebo). We also want to make sure the medicine is safe and doesn't cause too many side effects.
To do this, we'll be comparing two groups of people: one group will receive sibeprenlimab, and the other will receive a placebo. Neither you nor your doctor will know which one you are getting, to keep the results fair and unbiased. Both groups will continue with their current treatments for Sjögren's disease. The study will last for about 28 weeks, and after that, there might be an option to continue taking the active medicine in a follow-up part of the study.
We will be looking closely at how the disease changes over time for everyone in the study. This includes checking specific health scores that measure how active your Sjögren's disease is and how your symptoms affect your daily life. Your participation in a study like this helps doctors learn more about new treatments, which can benefit many people with Sjögren's disease in the future.
Key takeaways
- Tests a new medicine (sibeprenlimab) for Sjögren's disease.
- Compares the new medicine to a dummy (placebo) to see if it helps.
- Involves regular injections under the skin every four weeks.
- Study lasts for 28 weeks with potential for longer follow-up.
- Aims to improve Sjögren's symptoms and check safety.
Who may be eligible?
To join this study, you must be between 18 and 75 years old and have been diagnosed with Sjögren's disease by a doctor, specifically based on certain established criteria. Your Sjögren's disease symptoms should also be moderately active, as measured by a special score called the ESSDAI, which needs to be 5 or higher. You also need to meet other specific health requirements, such as certain levels of antibodies in your blood and good communication skills to take part fully.
There are also reasons why you might not be able to join. For instance, if you have other serious autoimmune conditions, have previously received certain types of strong immunosuppressant treatments, or have other significant health problems like uncontrolled diabetes, active cancer, or serious infections, you would not be able to participate. We also check for any signs of suicidal thoughts or behaviours.
You can continue taking some common Sjögren's medications like hydroxychloroquine or methotrexate, as long as your dose has been stable for at least 30 days before joining. If you are taking steroids, your dose must also be stable and no more than 10mg per day for at least 30 days.
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 between 18 and 75 years old?
- Have you been diagnosed with Sjögren's disease?
- Are your Sjögren's disease symptoms moderately active (ESSDAI score 5 or higher)?
- Have you been on stable doses of any current Sjögren's medications for at least 30 days?
- Do you *not* have another active autoimmune condition or serious health problem like cancer or uncontrolled diabetes?
What does participation involve?
If you decide to take part, you'll be assigned by chance to either receive the study medicine (sibeprenlimab) or a dummy medicine (placebo). You'll receive an injection under your skin every four weeks for 28 weeks. This will be done in addition to any existing Sjögren's treatments you are already on, which you will continue to take.
Throughout the study, you'll have regular visits to the clinic for check-ups. These visits will involve blood tests, physical examinations, and questions about your symptoms and how you're feeling. These assessments help the doctors understand if the medicine is working and if it's safe. The main part of the study will last for 28 weeks, which is about 7 months. After this, you might have the option to join an extension part of the study where everyone receives the active medicine, allowing for longer-term follow-up.
Potential risks and benefits
Locations (64)
- Medvin Clinical Research - RiversideVerified postcodeRiverside, United States
- Medvin Clinical Research - TujungaVerified postcodeTujunga, United States
- Bay Area Arthritis and OsteoporosisVerified postcodeBrandon, United States
- Clinical Research of West Florida IncVerified postcodeClearwater, United States
- GNP Research - FloridaVerified postcodeCooper City, United States
- Vantage Clinical Trials - Tampa - ClinEdge - PPDSVerified postcodeTampa, United States
- OrthoIllinois, LTDVerified postcodeRockford, United States
- Arnold Arthritis and RheumatologyVerified postcodeSkokie, United States
- Ochsner Clinic FoundationVerified postcodeBaton Rouge, United States
- Tufts University School of Dental MedicineVerified postcodeBoston, United States
- Albuquerque Center for RheumatologyVerified postcodeAlbuquerque, United States
- Bradenton Research Center IncVerified postcodeThe Bronx, United States
Common questions
What is Sjögren's disease?
Sjögren's disease is a condition that causes your immune system to mistakenly attack your body's moisture-producing glands, leading to dryness in the eyes and mouth, and sometimes affects other organs too.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the real medicine but contains no active drug. It helps researchers fairly compare the new medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, during the main part of the study, neither you nor your doctor will know whether you are receiving the real medicine or the placebo. This is called 'double-blind' and ensures the study results are fair.
How is the study medicine given?
The study medicine, sibeprenlimab, is given as an injection under the skin every four weeks.
What is a Phase 2 study?
A Phase 2 study is a stage of clinical research where a new medicine is tested on a larger group of people to see if it's effective for a specific condition and to further check its safety.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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