NCT03943589

A Study of Imlifidase in Patients With Guillain-Barré Syndrome

An Open-label, Single Arm, Multi-centre, Phase II Study Investigating Safety, Tolerability, Efficacy, Pharmacodynamics and Pharmacokinetics of Imlifidase in Patients With Guillain-Barré Syndrome, in Comparison With Matched Control Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hansa Biopharma AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study participants are patients which have been diagnosed with Guillain-Barré Syndrome (GBS) and are planned to receive treatment with intravenous immunoglobulin (IVIg). IVIg is a standard of care treatment for GBS patients. The patients in this study will be treated with the study medicine imlifidase on day 1, and with IVIg on days 3-7. The purpose of this study is to investigate the safety and effectiveness of imlifidase in patients diagnosed with GBS.

Detailed description

This is an open-label, single arm, multi-centre, phase II study of imlifidase in combination with standard care IVIg in patients with GBS. The study will recruit approximately 30 patients who are eligible for IVIg treatment based on current practice (i.e. GBS disability score \>3 and within 10 days of onset of weakness). All patients will receive imlifidase (Day 1) prior to standard care IVIg. There is growing body of evidence suggesting that GBS is an antibody-mediated disorder. In addition to supportive care, IVIg and Plasma Exchange (PE) are the two main immunological treatment options aimed at attenuating the autoreactive humoral immune response. Imlifidase is an IgG degrading enzyme with strict specificity. The hypothesis is that reduction of pathological antibodies may result in aborted progression, quicker recovery and less severe disease.

Conditions

• Guillain-Barré Syndrome (GBS)

Interventions

Type	Name	Description
DRUG	Imlifidase	All subjects will receive imlifidase (Day 1) prior to standard care IVIg

Timeline

• Start date: 2019-11-12
• Primary completion: 2024-02-27
• Completion: 2024-02-27
• First posted: 2019-05-09
• Last updated: 2025-04-09
• Results posted: 2025-04-09

Locations

11 sites across 3 countries: France, Netherlands, United Kingdom