Table of contents
Trial overview
The listed study is titled “An open label clinical study to evaluate ANX005 (also known as tanruprubart) in participants with Guillain-Barré syndrome (FORWARD Study).”[1] The trial is investigating HUMANISED IGG4 MONOCLONAL ANTIBODY AGAINST C1Q in people with Guillain-Barré syndrome, a nerve condition that can cause weakness.[1]
The study status is Authorised, and the planned enrollment is 30 participants.[1] It is an interventional study, which means researchers give the study treatment and then measure the results.[1]
Study design and phase
This is a Phase 3 trial.[1] Phase 3 studies usually involve more participants than early studies and are used to learn more about a treatment in a larger patient group.
The study is open label, which means the researchers and participants know what treatment is being given.[1] The brief summary says the study is designed to characterize the pharmacokinetic profile of a single dose of ANX005 30 mg/kg in participants recently diagnosed with GBS from North America and Europe.[1]
Pharmacokinetic profile means how the body handles the treatment after it is given, including how it is absorbed, moved around, and removed.[1]
Who can join the study
The trial is for participants recently diagnosed with Guillain-Barré syndrome.[1] The source also states that participants are from North America and Europe.[1]
No other eligibility details are given in the trial record provided, so the main known target group is people with a recent diagnosis of GBS in those regions.[1]
What the study measures
The main study goal listed in the source is to characterize the pharmacokinetic profile after a single dose.[1] In simple words, the trial wants to see what happens to the treatment in the body after one dose is given.
The source does not list additional endpoints, such as symptom improvement or long-term recovery measures, so the main reported focus is on pharmacokinetics.[1]
Trial summary
Only one trial is provided in the source data for HUMANISED IGG4 MONOCLONAL ANTIBODY AGAINST C1Q.[1] It is a Phase 3, authorised, open-label interventional study in 30 people with Guillain-Barré syndrome.[1]
The study focuses on recently diagnosed participants from North America and Europe and measures the pharmacokinetic profile after a single dose.[1] No other trials, conditions, or endpoints are listed in the provided data.[1]