A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
This research study is investigating a new medication called Dazodalibep for people who have Sjögren's Syndrome. Sjögren's Syndrome is a condition where the body's immune system attacks its own healthy cells, often causing dryness, but can also affect other parts of the body. This study is focusing on those whose Sjögren's is causing moderate to severe issues throughout their body. The main goal is to find out how well Dazodalibep works to improve these body-wide symptoms. The study will also look at how patients feel their symptoms are improving and if the treatment is safe and well-tolerated. Some participants will receive Dazodalibep, while others will receive a placebo (a dummy treatment without active medicine) to compare the effects.
At a glance
What is this study about?
Sjögren's Syndrome is a long-term condition where your body's immune system mistakenly attacks its own healthy tissues. This often causes dryness in the eyes and mouth, but it can also affect other organs and parts of your body, leading to more widespread problems. This study is specifically for people with Sjögren's Syndrome whose condition is causing these more serious, moderate to severe effects throughout their body.
The study is called a Phase 3 trial, which means it's one of the final stages of testing a new medicine before it can be considered for wider use. Researchers want to see if a new treatment called Dazodalibep can help reduce these body-wide symptoms of Sjögren's Syndrome. They will also be very interested in how people feel and if their quality of life improves, alongside checking for any side effects.
To understand if Dazodalibep is truly effective, some participants will receive the active treatment, while others will receive a 'placebo'. A placebo looks exactly like the real medicine but contains no active drug. This comparison helps researchers determine if any improvements are due to the treatment itself or other factors. All participants will be closely monitored by a medical team.
Key takeaways
- This study is testing a new drug, Dazodalibep, for Sjögren's Syndrome.
- It's for people with moderate to severe body-wide symptoms of Sjögren's.
- The study aims to see if Dazodalibep improves symptoms and is safe.
- Participants will receive either the study drug or a placebo.
- Close medical monitoring will be provided throughout the study.
Who may be eligible?
To join this study, you need to have already been diagnosed with Sjögren's Syndrome based on specific medical criteria. Your Sjögren's Syndrome should be causing moderate to severe problems in your body, even if you're already receiving some treatment for your symptoms. You also need to have certain antibodies (special proteins) in your blood, like anti-Ro or rheumatoid factor, which are common in Sjögren's.
There are also some reasons why you might not be able to join. For example, if you've had certain blood clot issues in the last two years, or if you've had cancer in the last five years (with some exceptions like certain skin cancers or fully treated cervical cancer). You also can't take part if you have other serious health problems that might make the study unsafe for you or make it hard to tell if the new medicine is working.
Additionally, if you have certain infections like hepatitis B, hepatitis C, HIV, or active tuberculosis, you wouldn't be able to join. Having a history of frequent infections or certain types of herpes zoster infections in the past year would also prevent participation. These rules are in place to keep everyone safe and ensure the study results are as clear 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.
- I have been diagnosed with Sjögren's Syndrome by my doctor.
- My Sjögren's is causing moderate to severe problems in my body.
- I've had certain specific antibodies found in my blood (like anti-Ro or rheumatoid factor).
- I haven't had any recent serious blood clots or certain types of cancer in the last 5 years.
- I don't have certain serious infections like hepatitis B, C, HIV, or active TB.
- I am aged 18 or older.
What does participation involve?
If you decide to join this study, you will be given either the study medicine, Dazodalibep, or a placebo (a dummy treatment). You won't know which one you are receiving. You will have regular visits to the clinic where the study team will monitor your health, take blood and other samples, and ask you about your symptoms and how you are feeling. These assessments will help the doctors understand how the treatment is affecting you.
Each visit will involve various tests and checks, and it's important to attend all scheduled appointments. The study team will explain the full schedule of visits and procedures. After the main treatment period, there will be follow-up appointments to continue monitoring your health. The total duration of your involvement in the study will be fully explained by the study team.
Potential risks and benefits
Locations (216)
- Arizona Arthritis & Rheumatology Associates - AvondaleVerified postcodeAvondale, United States
- Arizona Research Clinic PLLCVerified postcodeChandler, United States
- Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais LnVerified postcodeFlagstaff, United States
- Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome StVerified postcodeGilbert, United States
- Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly LnVerified postcodeGlendale, United States
- Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove RdVerified postcodeTucson, United States
- UCSD Altman Clinical and Translational Research Institute BuildingVerified postcodeLa Jolla, United States
- Inland Rheumatology Clinical Trials IncorporatedVerified postcodeUpland, United States
- Tekton Research, LLC - 2121 E Harmony Rd - PPDSVerified postcodeFort Collins, United States
- Bradenton Research Center IncVerified postcodeBradenton, United States
- Clinical Research of West Florida Inc - ClearwaterVerified postcodeClearwater, United States
- University of Miami - Leonard M. Miller School of MedicineVerified postcodeMiami, United States
Common questions
What is Sjögren's Syndrome?
Sjögren's Syndrome is an autoimmune disease where your body's immune system attacks healthy cells, often causing dry eyes and mouth, but can also affect other organs.
What is Dazodalibep?
Dazodalibep is a new medicine being tested to see if it can help people with Sjögren's Syndrome that is causing moderate to severe problems in their body.
Will I definitely get the new medicine?
No, participants will either receive Dazodalibep or a placebo (a dummy treatment). You won't know which one you are getting.
What is a Phase 3 study?
A Phase 3 study is one of the final stages of testing a new medicine to see how well it works and if it's safe before it can be considered for wider use.
Can I stop participating if I want to?
Yes, you can leave the study at any time, for any reason, without it affecting your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.