CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Imlifidasedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03943589
NCT03943589Phase 2Completed
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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

Hansa Biopharma AB·interventional·Posted May 9, 2019·Updated Apr 9, 2025

In Brief

A Phase 2 clinical trial evaluating Imlifidase for Guillain-Barré Syndrome (GBS). Completed, enrolled 30 participants across 11 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGuillain-Barré Syndrome (GBS)
CountriesFrance, Netherlands, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 9, 2019
Enrollment StartNov 12, 2019
Primary CompletionFeb 27, 2024
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 7.1 years ago

Interventions

Imlifidasedrug

All subjects will receive imlifidase (Day 1) prior to standard care IVIg