A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
This research study is about a new medicine called Dazodalibep for people living with Sjögren's Syndrome, a condition that affects your body's moisture-producing glands. The main goal is to find out if Dazodalibep can help reduce common Sjögren's symptoms like dry eyes and mouth, and how it affects your overall well-being. Researchers will also be checking to make sure the medicine is safe and if your body can handle it well. Participants will either receive Dazodalibep or a dummy medicine (placebo) to fairly compare its effects. This is a Phase 3 study, meaning it's one of the final stages of testing before a medicine might be approved for wider use.
At a glance
What is this study about?
You've been asked to read about a research study looking into a new medicine called Dazodalibep for people with Sjögren's Syndrome. Sjögren's Syndrome is a long-term condition where your immune system mistakenly attacks healthy parts of your body, especially moisture-producing glands. This can lead to symptoms like very dry eyes and mouth, tiredness, and joint pain. This study is focusing on people whose Sjögren's symptoms are in the moderate to severe range.
The main idea behind this study is to see if Dazodalibep can make a real difference in how people with Sjögren's Syndrome feel. Researchers want to know if it can ease symptoms that patients report themselves. They're also looking at general quality of life, specific symptoms, and even things like how much saliva your body produces. Another very important part of the study is to check if Dazodalibep is safe to use and if people can tolerate it without too many side effects.
To make sure the study gives clear answers, some participants will receive the new medicine, Dazodalibep, while others will receive a 'placebo'. A placebo looks exactly like the real medicine but doesn't contain any active drug. This helps researchers understand if any improvements are truly due to Dazodalibep or if they might be due to other factors. This is a Phase 3 study, which means it's a large-scale study that usually takes place after earlier research has shown some promise for a new treatment.
Key takeaways
- This study is testing a new medicine, Dazodalibep, for Sjögren's Syndrome.
- It aims to see if Dazodalibep helps with symptoms and is safe.
- Some participants will get the new medicine, others a dummy pill (placebo).
- It's for people with moderate to severe Sjögren's symptoms.
- Comprehensive health checks, especially for TB, are required to join.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you would need to have received a diagnosis of Sjögren's Syndrome based on specific medical criteria. Your symptoms would also need to be in the moderate to severe range, based on a special scoring system your doctor would use. You'd also need to have positive results for certain antibodies in your blood that are often seen in Sjögren's Syndrome, and still have some level of saliva production.
There are also some important health checks you'd need to pass. For example, you should not have an active serious illness like cancer (within the last 5 years), or certain other immune conditions like polymyositis or systemic sclerosis. You also shouldn't have had blood clots like DVT or pulmonary embolism recently. You would also need to be up-to-date with your SARS-CoV-2 (COVID-19) vaccinations, unless you have refused the vaccine.
Crucially, you would need to be thoroughly checked for tuberculosis (TB). This includes not having a history of active TB (unless successfully treated), and having a negative TB test result. If there's any suspicion of TB, or if you've been in close contact with someone who has active TB, you might not be able to join.
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 symptoms are moderate to severe.
- I have had, or would be willing to have, specific blood tests linked to Sjögren's.
- I still produce some saliva.
- I don't have active cancer (within the last 5 years) or certain other serious health conditions.
- I do not have active tuberculosis (TB) and have passed/can pass all TB checks.
What does participation involve?
If you decide to take part in this study, you'll be given either the new medicine, Dazodalibep, or a dummy medicine (placebo). You won't know which one you're receiving, and neither will the study team, to keep things fair. You'll have regular visits to the clinic where you'll have various check-ups, blood tests, and answer questions about how you're feeling and your symptoms. This will help the research team keep track of your health and how the medicine might be affecting you. The exact number of visits, tests, and the total length of your participation would be fully explained to you before you agree to join.
Potential risks and benefits
Locations (194)
- 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
- Medvin Clinical Research - CovinaVerified postcodeCovina, United States
- UCSD Altman Clinical and Translational Research Institute BuildingVerified postcodeLa Jolla, United States
- Inland Rheumatology Clinical Trials IncorporatedVerified postcodeUpland, United States
- Medvin Clinical ResearchVerified postcodeWhittier, United States
- Tekton Research, LLC - 2121 E Harmony Rd - PPDSVerified postcodeFort Collins, United States
- Bradenton Research Center IncVerified postcodeBradenton, United States
Common questions
What is Sjögren's Syndrome?
Sjögren's Syndrome is a long-term autoimmune disease where your immune system attacks glands that produce moisture, leading to dryness in eyes, mouth, and other parts of the body.
What is a Phase 3 study?
Phase 3 is one of the later stages of clinical trials. It involves a larger number of people to confirm how well the new medicine works and if it's safe, compared to existing treatments or a placebo.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real treatment but contains no active drug. It helps researchers fairly compare the new medicine's effects.
How long will the study last?
The exact duration would be explained by the study team, but clinical trials often involve follow-up over several months or longer. You'll know all time commitments upfront.
Do I have to pay to be in the study?
No, clinical trials usually cover the cost of the study medicine and any study-related tests or visits. You wouldn't be charged for your participation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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