A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease
This research study is testing a new medicine called CLN-978 for adults who have Sjögren's disease. Sjögren's disease is a long-term condition that can cause dry eyes, dry mouth, and other issues. In this study, CLN-978 is given as an injection just under the skin. It's a 'Phase 1b' study, which means it's an early stage of testing new treatments. The main goals are to find out if the medicine is safe, how well people tolerate it, and if it helps with the symptoms of moderate to severe Sjögren's disease. All participants will receive the study medicine, and doctors will carefully monitor their health throughout.
At a glance
What is this study about?
Many people in the UK live with Sjögren's disease, a condition where the body's immune system mistakenly attacks its own healthy cells, often in the glands that produce tears and saliva. This can lead to very dry eyes and mouth, as well as problems in other parts of the body like joints, skin, or organs. Finding new and effective ways to manage Sjögren's symptoms and improve quality of life is really important.
This particular study is focusing on a new medicine called CLN-978. It's designed to target specific cells in the body that are thought to play a role in Sjögren's disease. The medicine is given as an injection under the skin rather than into a vein, which can sometimes be more convenient for patients.
Because this is an early-stage study, called 'Phase 1b,' the main goal is to check how safe CLN-978 is and how well people tolerate it, especially when given in different doses. Researchers will also be looking to see if there are any signs that it might help improve the symptoms of Sjögren's disease. This type of research is a crucial step in developing new treatments that could one day benefit many people.
Key takeaways
- This study is for adults with moderate to severe Sjögren's disease.
- It's testing a new medicine called CLN-978 given by injection under the skin.
- The main aim is to check the medicine's safety and how well it's tolerated.
- All participants will receive the active study medicine.
- Regular clinic visits are needed to monitor your health.
Who may be eligible?
To join this study, you must be an adult aged 18 or older and have a confirmed diagnosis of Sjögren's disease for at least six months. Your Sjögren's disease needs to be active and considered moderate to severe by the doctors. You'll also need to have certain blood test results within a healthy range, as these tests help ensure it's safe for you to take part and that your body is likely to respond well to the medicine.
There are also some reasons why you might not be able to join. For example, if you have another autoimmune disease like rheumatoid arthritis or lupus, or if you've recently had certain serious infections like Hepatitis B, C, HIV, or active tuberculosis. People who have had a stroke, seizures, or certain other brain or nerve conditions, or those with very severe kidney disease, would also not be able to take part. This is because these conditions could either make the study medicine unsafe for you or make it harder for the researchers to understand the study results accurately.
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 Sjögren's disease?
- Do your doctors consider your Sjögren's disease to be active and moderate to severe?
- Are you generally in good health apart from your Sjögren's, based on recent blood tests?
- Have you not had a recent serious infection or a history of certain other serious health problems?
What does participation involve?
If you decide to take part in this study, you will receive the study medicine, CLN-978, as an injection under your skin. This isn't a 'blinded' study, which means you and your doctors will know you are receiving the active medicine. You'll have regular visits to the clinic so the medical team can monitor your health carefully, perform physical exams, and take blood and urine samples. They will also ask you questions about your symptoms and how you're feeling. The study team will explain how long you'll be involved and what each visit will include. All these assessments help the researchers understand how safe the medicine is and if it's having any effect on your Sjögren's disease.
Potential risks and benefits
Locations (11)
- Cullinan Investigative SiteVerified postcodeOrlando, United States· Recruiting
- Cullinan Investigative SiteVerified postcodeMemphis, United States· Recruiting
- Cullinan Investigative SiteVerified postcodePlano, United States· Recruiting
- Cullinan Investigative SiteVerified postcodeWebster, United States· Recruiting
- Cullinan Investigative SiteVerified postcodeSalt Lake City, United States· Recruiting
- Cullinan Investigative SiteVerified postcodeBrest, France· Recruiting
- Cullinan Investigative SiteVerified postcodeLe Kremlin-Bicêtre, France· Recruiting
- Cullinan Investigative SiteVerified postcodeStrasbourg, France· Recruiting
- Cullinan Investigative SiteVerified postcodeErlangen, Germany· Recruiting
- Cullinan Investigative SiteVerified postcodeHanover, Germany· Recruiting
- Cullinan Investigative SiteVerified postcodeRoma, Italy· Recruiting
Common questions
What is Sjögren's disease?
It's a long-term condition where your body's immune system attacks its own healthy cells, often leading to dry eyes and mouth, and sometimes affecting other organs.
What is CLN-978?
CLN-978 is a new medicine being tested. It's designed to target specific cells in your body that are thought to be involved in Sjögren's disease.
How is the medicine given?
The medicine is given as an injection just under your skin, similar to some routine injections.
What does 'Phase 1b' mean?
It's an early stage of testing for a new medicine. The main goals are to check if it's safe, how well people tolerate it, and to look for any early signs it might help.
Will I get a placebo (dummy medicine)?
No, in this particular study, everyone who takes part will receive the active study medicine, CLN-978.
How to find out more
Amy Gubits, MPH
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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