An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
This study, called FORWARD, is testing a new medicine called Tanruprubart (or ANX005) for people who have Guillain-Barré Syndrome (GBS). GBS is a rare condition that affects your nerves, often causing weakness. The main goals of this study are to understand how safe this new medicine is, how much of it stays in the body, and if it shows early signs of helping people improve. This is an "open-label" study, meaning both the doctors and the patients will know they are receiving the study medicine. It includes both adults and children aged 8 to 85 years and is taking place in the UK, Europe, Canada, and the United States. Researchers want to learn more about how this treatment might help people with GBS.
At a glance
What is this study about?
Guillain-Barré Syndrome (GBS) is a rare but serious condition where your body's immune system mistakenly attacks your nerves. This can lead to muscle weakness, tingling, and sometimes paralysis. Currently, there are treatments that help, but researchers are always looking for new ways to improve recovery and outcomes for people with GBS.
This study is looking at a new investigational medicine called Tanruprubart (you might also see it called ANX005). The main purpose of this research is to see how this medicine acts in the body, how well people tolerate it (its safety), and if there are any early signs that it helps with GBS symptoms. It's a 'Phase 3' study, which means it's one of the final steps before a new medicine might become widely available, if it proves to be safe and effective.
The study is taking place in several countries, including the UK, Canada, the US, and across Europe. It's designed to gather important information from a diverse group of patients, including adults and children as young as 8 years old, to understand how Tanruprubart might help people recover from GBS. By joining studies like this, volunteers play a crucial role in advancing medical knowledge and potentially finding better treatments for conditions like GBS.
Key takeaways
- This study is testing a new medicine (Tanruprubart/ANX005) for Guillain-Barré Syndrome (GBS).
- It aims to check the medicine's safety, how it works in the body, and early signs of its effectiveness.
- The study is for adults and children (8-85 years old) with a recent GBS diagnosis.
- Participation is voluntary, and you can withdraw at any time.
- Your involvement could help researchers find better treatments for GBS in the future.
Who may be eligible?
To be considered for this study, you would first need to have a clear diagnosis of Guillain-Barré Syndrome (GBS) confirmed by doctors, following specific national guidelines. It's important that your GBS-related muscle weakness started no more than 10 days before the study treatment begins. Also, your current level of weakness needs to be a certain severity, meaning you have significant difficulty moving around or are unable to walk without help.
There are also some reasons why you might not be able to join. For example, if you have already received common GBS treatments like plasma exchange or IV immunoglobulin (IVIg) within the last 90 days, or if you are planning to have them, you wouldn't be eligible. The study is specifically for the most common form of GBS that affects your arms and legs, so if your GBS only affects other parts of your body, you wouldn't be able to take part.
Other health conditions or medications might also mean you can't join, but the study team would discuss all of this with you in detail to see if the study is right for your situation.
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 Guillain-Barré Syndrome (GBS).
- My GBS-related weakness started within the last 10 days.
- My GBS has caused significant weakness, making it hard to move or walk.
- I have not had treatments like plasma exchange or IVIg for GBS recently (within 90 days) and don't plan to.
- My GBS affects my arms and legs (not just other parts of my body).
- I am between 8 and 85 years old.
What does participation involve?
If you decide to take part in this study, you would receive the study medicine, Tanruprubart, through an infusion (like a drip into your arm). The study team would closely monitor you, especially during and after the infusions, to check for any side effects and see how you are responding. You would have several visits to the clinic for assessments, which might include physical examinations, blood tests, and tests to check your muscle strength and movement. The study involves regular follow-up visits over a period of time to track your progress. The total duration of your participation would be explained fully by the study team, but it typically involves several months of observation and visits. You'll be given all the details about the schedule and what's involved if you are eligible and interested.
Potential risks and benefits
Locations (28)
- St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (Dignity Health)Verified postcodePhoenix, United States· Recruiting
- HonorHealth Bob Bové Neuroscience InstituteVerified postcodeScottsdale, United States· Recruiting
- Profound Research LLCVerified postcodeCarlsbad, United States· Recruiting
- Loma LindaVerified postcodeLoma Linda, United States· Recruiting
- Children's Hospital of Orange CountyVerified postcodeOrange, United States· Recruiting
- University of California IrvineVerified postcodeOrange, United States· Recruiting
- Stanford UniversityVerified postcodePalo Alto, United States· Recruiting
- University of Colorado HospitalVerified postcodeAurora, United States· Recruiting
- GeorgetownVerified postcodeWashington D.C., United States· Recruiting
- Mayo Clinic FloridaVerified postcodeJacksonville, United States· Recruiting
- University of Kansas Medical CenterVerified postcodeKansas City, United States· Recruiting
- Ochsner LSU HealthVerified postcodeShreveport, United States· Recruiting
Common questions
What is Guillain-Barré Syndrome (GBS)?
GBS is a rare condition where your body's immune system attacks your nerves, often causing weakness in your arms and legs.
What is Tanruprubart (ANX005)?
It's a new medicine being tested in this study to see if it can help people with GBS.
Why is this study called 'open label'?
Open label means that both you and the doctors will know that you are receiving the study medicine, not a dummy treatment.
Who can join this study?
Adults and children aged 8 to 85 who have been recently diagnosed with GBS and meet specific health requirements.
What if I change my mind about taking part?
You can decide to leave the study at any time, and your medical care will not be affected.
How to find out more
Study Coordinator
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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