A phase II study investigating imlifidase in Guillain-Barré Syndrome
Research type
Research Study
Full title
An open-label, single arm, multi-centre, phase II study investigating safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS), in comparison with matched control patients
IRAS ID
259622
Contact name
John Aaron Goodfellow
Contact email
Sponsor organisation
Hansa Medical AB
Eudract number
2018-001059-12
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Guillain-Barré Syndrome (GBS) is a rare disorder in which the body's immune system attacks the nerves. Weakness and tingling in the extremities are usually the first symptoms.
Normally antibodies act by helping the immune system to protect the body. In GBS, the antibodies work in a different way by attacking the body causing damage to the nerves.
The purpose of this study is to investigate the safety and effectiveness of a study drug under development named imlifidase in patients diagnosed with GBS.
In previous research studies it has been shown that imlifidase is highly effective in removing antibodies.
The study participants are patients who have been diagnosed with GBS and are planned to receive Intravenous Immunoglobulin (IVIg) which is one of the main standard treatment for GBS.
This phase II study is an open label study (where both the patient and the doctor know which study medicine is being given). The patients will be treated with the study medicine imlifidase on day 1, and with IVIg on days 3-7.
The total duration of the study, including patient’s screening, treatment and follow-up visits, will not exceed 13 months and will consist of 10 visits (9 visits at the hospital and one visit by phone).
The study is sponsored by Hansa Medical AB in Sweden and patients will be recruited in the Glasgow area and treated at Queen Elizabeth University Hospital in Glasgow.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
19/EM/0087
Date of REC Opinion
29 May 2019
REC opinion
Further Information Favourable Opinion