A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
This research is a continuation study focusing on a new medicine called dazodalibep, specifically designed for individuals living with Sjögren's Syndrome. The main goal is to understand the long-term safety and how well people tolerate this treatment over time. This phase 3 study will include participants who have already completed an earlier study with dazodalibep or a placebo (a dummy treatment). By continuing to monitor these individuals, researchers hope to gather important information about the medicine's long-term effects, which is crucial for determining its overall safety and usefulness in treating Sjögren's Syndrome. It's about ensuring any new treatment is safe and tolerable for long-term use.
At a glance
What is this study about?
This study is a long-term follow-up for a medicine called dazodalibep, which is being investigated as a treatment for Sjögren's Syndrome. Sjögren's Syndrome is a long-lasting condition where the body's immune system mistakenly attacks healthy cells, particularly those that produce tears and saliva. This can lead to symptoms like dry eyes and a dry mouth, as well as joint pain and tiredness. Researchers are hopeful that dazodalibep could help manage these symptoms and improve the lives of people with Sjögren's.
The main purpose of this particular study is to carefully monitor the safety of dazodalibep over a longer period. While earlier studies focused on its effectiveness and shorter-term safety, it's very important to understand how any new medicine impacts the body when taken for an extended time. This helps to identify any potential side effects that might only appear after long-term use and ensures the medicine is suitable for ongoing treatment.
By inviting participants from previous dazodalibep studies to continue, researchers can build a comprehensive picture of the medicine's safety profile. This kind of long-term data is really valuable for medicines intended for conditions like Sjögren's, which require ongoing management. The information gathered will contribute significantly to understanding whether dazodalibep can become a safe and effective long-term treatment option.
Key takeaways
- This study is for people who've already been in a dazodalibep study for Sjögren's Syndrome.
- The main aim is to check the long-term safety and experience of taking dazodalibep.
- It helps researchers understand how the medicine works over an extended period.
- Regular health checks will be part of participating.
- You can discuss any concerns with the study team.
- Participation is voluntary, and you can withdraw at any point.
Who may be eligible?
To join this study, participants must have already taken part and completed one of two specific previous studies (HZNP-DAZ-301 or HZNP-DAZ-303) that looked at dazodalibep for Sjögren's Syndrome. They must have received either the active medicine or a placebo (a dummy treatment) in that earlier study, and finished it up to the 48-week mark.
There are also some reasons why you might not be able to join. For instance, if you have a serious active infection, or if you're already planning to be involved in another clinical study involving a new medicine or procedure. You also can't participate if you need planned surgery or hospitalisation that would interfere with the study's safety checks, or if you plan to have a 'live' vaccine during the study.
For women who could become pregnant, it's important to agree to use a specific type of contraception during the study and for 12 weeks after the last dose of the study medicine. Women who are pregnant, breastfeeding, or planning to become pregnant during the study will also not be able to take part. The study team will review all your medical information from the previous study to make sure it's safe for you to continue.
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.
- Have I already completed a previous dazodalibep study (HZNP-DAZ-301 or HZNP-DAZ-303) for Sjögren's Syndrome?
- Do I have any significant active infections needing treatment right now?
- Am I planning to participate in another clinical trial with a new medication or procedure soon?
- For women: Am I pregnant, breastfeeding, or planning to become pregnant during the study, or could I use the required contraception?
- Do I have any major planned surgeries or hospitalisations that would clash with study visits?
What does participation involve?
This study is a continuation for people who have already been part of a previous study on dazodalibep for Sjögren's Syndrome. If you join, you will continue to receive the study medicine (dazodalibep). The exact schedule of visits and assessments will be provided by the study team, but throughout the study, you'll have regular checks to monitor your health and how you're responding to the treatment. These checks help the researchers understand the long-term safety and tolerability of the medicine. The total duration of your participation in this long-term extension study will be explained in detail by the study staff.
Potential risks and benefits
Locations (174)
- Arizona Arthritis & Rheumatology Associates - AvondaleVerified postcodeAvondale, United States· Recruiting
- Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais LnVerified postcodeFlagstaff, United States· Recruiting
- Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome StVerified postcodeGilbert, United States· Recruiting
- Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly LnVerified postcodeGlendale, United States· Recruiting
- Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove RdVerified postcodeTucson, United States· Recruiting
- Samy Metyas MD IncVerified postcodeCovina, United States· Recruiting
- UCSD Altman Clinical and Translational Research Institute BuildingVerified postcodeLa Jolla, United States· Recruiting
- Tekton Research, LLC - 2121 E Harmony Rd - PPDSVerified postcodeFort Collins, United States· Recruiting
- Bradenton Research Center IncVerified postcodeBradenton, United States· Recruiting
- Clinical Research of West Florida Inc - ClearwaterVerified postcodeClearwater, United States· Recruiting
- BayCare Medical Group Primary Care and Rheumatology - TampaVerified postcodeTampa, United States· Recruiting
- Tufts University School of Dental MedicineVerified postcodeBoston, United States· Recruiting
Common questions
What is Sjögren's Syndrome?
Sjögren's Syndrome is a long-term condition where your body's immune system mistakenly attacks healthy cells, often causing dryness as it affects glands that produce tears and saliva.
What is dazodalibep?
Dazodalibep is an investigational medicine, meaning it's being researched, for Sjögren's Syndrome. It aims to help manage the symptoms of the condition.
Why is this a 'long-term extension' study?
It's a continuation study for people who were in a previous trial. The goal is to gather more information about the medicine's safety and how well people tolerate it when taken over a longer period.
Will I definitely receive the active medicine?
Since this is an extension study, participants will continue to receive dazodalibep. In the previous studies, some received dazodalibep and some a placebo, but for this extension, everyone receives the active medicine.
Can I leave the study at any time?
Yes, you are always free to leave the study at any time, for any reason. Your decision will not affect your medical care.
How to find out more
Amgen Call Center
Always speak to your GP or specialist before deciding to take part in a study.
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