A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Abiprubart in Participants with Sjögren’s Disease
This research is investigating a new medication called Abiprubart for people with Sjögren’s disease. It's a 'Phase 2' study, which means it’s still in the earlier stages, focusing on finding the right dose and checking how safe and effective the medicine is. Participants will receive either the active medicine or a 'placebo' (a dummy medicine that looks the same but contains no active ingredients). This helps researchers understand the true effects of Abiprubart. The main goal is to see if the medicine can reduce symptoms and improve measures of disease activity over 24 weeks. This step is crucial for developing better treatments for Sjögren’s disease.
At a glance
What is this study about?
This study is looking into a new treatment called Abiprubart for a condition called Sjögren’s disease. Sjögren’s disease is a long-term illness that affects certain glands in your body, often leading to dry eyes and a dry mouth, and can also cause tiredness and joint pain. The main purpose of this study is to find out if Abiprubart can help reduce these symptoms and improve how people with Sjögren’s disease feel.
This is a 'Phase 2' trial, which is an important stage in developing new medicines. In this phase, researchers are trying to learn more about the medicine's effects, including finding the most suitable dose and making sure it's safe to use. To do this, some participants will receive the actual medicine, Abiprubart, while others will receive a 'placebo'. A placebo is a substance that looks exactly like the medicine but doesn't contain any active ingredients. This helps scientists compare the effects of the real medicine against not taking it, so they can be sure any improvements are due to Abiprubart itself.
The study will follow participants for 24 weeks, carefully monitoring any changes in their Sjögren’s disease symptoms and overall health. Researchers will use special scores and tests to measure how the disease is affecting people and how it responds to the treatment. This information will help them decide if Abiprubart should move forward to larger studies, bringing us closer to potentially better treatments for Sjögren’s disease.
Key takeaways
- The study is testing a new medicine called Abiprubart for Sjögren’s disease.
- It's a Phase 2 trial, focusing on safety and finding the right dose.
- Participants will receive either the active medicine or a placebo (dummy medicine).
- The study will last for 24 weeks, plus follow-up visits.
- Open to adults aged 18 and over with Sjögren’s disease.
- Aiming to improve understanding and treatment for Sjögren’s disease.
Who may be eligible?
To join this study, you must be at least 18 years old. There's no upper age limit, so adults of any age are welcome to take part.
This study is open to both men and women who have been diagnosed with Sjögren’s disease. The research team will also check specific health details and your medical history to make sure the study is a good fit for you and safe for your participation. This is standard procedure to protect your health and ensure the study results are as accurate as possible.
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?
- Have you been diagnosed with Sjögren’s disease?
- Are you able to attend regular clinic appointments for 24 weeks?
- Are you comfortable with receiving intravenous medication (via a drip)?
- Are you willing to potentially receive a placebo instead of the active drug?
What does participation involve?
If you join this study, you will have regular visits to the clinic over a period of 24 weeks. Each visit will involve various assessments, such as physical examinations, blood tests, and questionnaires to track your symptoms and how you're feeling. You will also receive either the study medicine, Abiprubart, or a placebo (a dummy medicine), which will be given as injections. The study is 'double-blind', meaning neither you nor the study doctors will know whether you are receiving the active medicine or the placebo until the study is over. After the 24-week treatment period, there will be follow-up visits to continue monitoring your health and any effects of the treatment.
Potential risks and benefits
Locations (6)
- —UnverifiedGermany
- —UnverifiedHungary
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedPoland
Common questions
What is Sjögren’s disease?
It's a long-term condition that causes your body's immune system to attack glands that produce moisture, leading to very dry eyes and mouth, and sometimes affects other parts of the body.
What does a 'Phase 2' study mean?
It means this is an early stage of testing a new medicine in a small group of people to see if it's safe, how well it works, and to find the best dose, before it can be studied more widely.
What is a 'placebo'?
A placebo is a dummy medicine that looks exactly like the real medicine but contains no active ingredients. It helps researchers understand if the new medicine is truly effective or if improvements are due to other factors.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know whether you are receiving the real medicine or the placebo until after the study has finished. This is standard practice in these types of trials.
How long will the study last?
The main part of the study where you receive treatment will last for 24 weeks, followed by some additional monitoring visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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