The FORWARD STUDY is an open-label study in North America and Europe. The study has been reviewed and approved for ethics and safety. All patients will receive Tanruprubart. The purpose of this study is to better understand Tanruprubart’s effects by collecting information such as:
What happens to it in the body
How it affects Guillain-Barré Syndrome
How well it may work and is tolerated
What is Tanruprubart?
Tanruprubart (ANX005) is an investigational drug being studied in patients diagnosed with GBS. Tanruprubart:
is not approved by the FDA or any other healthcare authority
targets a key part of the immune systemthat is involved in GBS to temporarily shut it down and prevent nerve damage
is still being studied for side effects. It may have an effect on the immune system. The study doctor will discuss the potential benefits and risks of the study with you
has been studied in a previous study to test whether it works and is safe in patients diagnosed with GBS
About the FORWARD STUDY
The FORWARD study is an open-label study in North America and Europe
The study has been reviewed and approved for ethics and safety
All patients will receive Tanruprubart
The purpose of this study is to better understand tanruprubart’s effects by collecting information such as:
What happens to it in the body
How it affects GBS
How well it may work and is tolerated
If you are 12 to 85 years of age and have been diagnosed with GBSin about the last week and have not received IVIg or PE, you may qualify for the FORWARD study. Your study doctor will check if you can take part in the study as there are additional eligibility criteria
You will be in the study for about 6 months if you decide to take part
You can change your mind and leave the study at any time
What happens during the study?
If you are eligible for study participation, you will be administered a single intravenous infusion of tanruprubart
You will have follow-up for 6 months to help us better understand tanruprubart and ensure your health is monitored closely
The study includes a screening and treatment period:
Screening (up to 2 days)
If you choose to take part in this study, over the next 1–2 days, the study doctor will check if you are eligible
Study treatment period
If you are eligible, you will be given tanruprubart on the first day
You will be in the hospital for at least 8 days to allow close monitoring
If you stay in the hospital for more than 8 days =, you will continue to be monitored
There are about 2 planned study visits back at the hospital to check on your health. You may also have some virtual follow-up appointments
Tests and assessments will include:
Questions about your past and current health
Questions about how you are feeling
Tests of muscle strength
Physical exams
Heart health tests
Blood and urine tests
If you are eligible, choosing to take part is up to you. You can change your mind and leave the study at any time
