An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
This study is an extension to previous research on a new drug called litifilimab for adults with Systemic Lupus Erythematosus (SLE), often known simply as lupus. The main goal is to understand the long-term safety of litifilimab and whether it can help control lupus symptoms and reduce disease activity over time. Participants will have been part of earlier litifilimab studies. They will continue to receive litifilimab injections, and researchers will monitor their health, lupus symptoms, and quality of life regularly for up to 180 weeks. An optional extra part of the study will also test a new way to give the medication.
At a glance
What is this study about?
This study, called an 'extension study', is designed to learn more about a new drug called litifilimab for people living with Systemic Lupus Erythematosus (SLE), commonly known as lupus. Lupus is a long-term condition that can cause the body's immune system to attack its own tissues and organs. This study is for adults who have already taken part in earlier studies of litifilimab and have ongoing symptoms of lupus despite using their usual medications. The main focus is to check the long-term safety of litifilimab and to see if it helps to improve or manage lupus symptoms over a longer period.
Researchers want to understand how many people experience side effects, both mild and serious, when using litifilimab for an extended time. They will also closely track how the drug affects lupus symptoms and overall disease activity using various health checks and questionnaires. Furthermore, the study will look at how litifilimab might impact a person's quality of life and how their immune system responds to the treatment. This will help doctors understand more about how litifilimab works and its potential benefits for people with lupus.
An optional part of the study will also look at a new way to administer litifilimab. Participants in this optional section will try an automatic injection device, which could make taking the medication easier in the future. This will be compared to the current method of injection to see if it's equally safe and well-received by patients.
Key takeaways
- This study explores the long-term safety of litifilimab for adults with lupus.
- It’s for people who've already taken part in previous litifilimab studies.
- Participants will receive regular litifilimab injections and be closely monitored.
- The study will track lupus symptoms, disease activity, and quality of life.
- An optional part will test a new, easier way to give the injections.
Who may be eligible?
You might be able to join this study if you are an adult who has already completed one of the previous 52-week studies involving litifilimab (studies coded 230LE303 or 230LE304). This means you stayed in the previous study for its full duration and had your final health check-up.
However, you will not be able to join if you left the previous studies early, either because you stopped taking the study medication or withdrew from the study entirely before the 52 weeks were up. You also can't join if your lupus got significantly worse in a way that required major changes to your existing lupus medications, or if you were taking other experimental or unlicensed drugs for your lupus during the earlier studies.
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 an adult (18 years or older)?
- Did you complete one of the previous 52-week litifilimab studies (230LE303 or 230LE304)?
- Did you stay in that previous study for the full 52 weeks?
- Has your lupus not worsened significantly to require major changes in your main lupus medications?
- Have you not used any other experimental drugs for your lupus during the previous study?
What does participation involve?
If you join this study, your participation will begin from what would have been your 52-week visit in the previous study. If you were already receiving litifilimab in the earlier study, you'll continue on the same dose. If you were receiving a dummy treatment (placebo), you'll be randomly assigned to receive either a high or low dose of litifilimab.
The study medication will be given as an injection under your skin once every four weeks. You'll continue to take your regular lupus medications as well. Neither you nor the study team will know which dose of litifilimab you are receiving. The main treatment part of the study will last for 156 weeks (about three years), followed by a safety check-up period of up to 24 weeks.
Overall, you could have up to 47 study visits, and your total time in the study could be up to 180 weeks (around 3.5 years).
There's also an optional extra part of the study for some participants after at least 4 months. This involves testing a new automatic injection device for litifilimab for three months. This optional part will include additional visits related to the device.
Potential risks and benefits
Locations (186)
- Arizona Arthritis & Rheumatology Associates, P.C.Verified postcodePhoenix, United States
- Wallace Rheumatic Study CenterVerified postcodeBeverly Hills, United States
- Care Access Research - Huntington BeachVerified postcodeHuntington Beach, United States
- Providence Facey Medical FoundationVerified postcodeMission Hills, United States
- Inland Rheumatology Clinical Trials, Inc.Verified postcodeUpland, United States
- University of Colorado DenverVerified postcodeAurora, United States
- Georgetown University Hospital-MedstarVerified postcodeWashington D.C., United States
- Arthritis & Rheumatic Disease SpecialtiesVerified postcodeAventura, United States
- Highlands Research InstituteVerified postcodeAvon Park, United States
- Clinical Research of West Florida - CorporateVerified postcodeClearwater, United States
- GNP Research at Mark Jaffe, MDVerified postcodeCooper City, United States
- Omega Research ConsultantsVerified postcodeDeBary, United States
Common questions
What is Systemic Lupus Erythematosus (SLE)?
SLE, or lupus, is a long-term condition where your body's immune system mistakenly attacks its own healthy tissues and organs.
What is litifilimab?
Litifilimab is a new drug being investigated for its potential to treat lupus symptoms and manage the disease.
What does 'extension study' mean?
An extension study means this research is a follow-up to earlier studies, allowing researchers to gather more information over a longer period from people who already participated.
Will I know if I'm getting an active drug or a dummy treatment?
No, you and the study team won't know which dose of litifilimab you're receiving. This is called 'dose-blind' and helps ensure the study results are unbiased.
How long will I be in the study?
Your total time in the study could be up to 180 weeks, which is about 3.5 years.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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