A Study of Imlifidase in Patients With Guillain-Barré Syndrome (NCT03943589) | Clinical Trial Compass
CompletedPhase 2
A Study of Imlifidase in Patients With Guillain-Barré Syndrome
France, Netherlands, United Kingdom30 participantsStarted 2019-11-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed Informed Consent obtained before any study-related procedures.
. Willingness and ability to comply with the protocol.
. Male or female aged ≥18 years at the time of screening.
. GBS diagnosed according to National Institute of Neurological Disorders and Stroke (NINDS) diagnostic criteria (Asbury et al. 1990).
. Onset of weakness due to GBS is not more than 10 days prior to screening.
. Unable to walk unaided for \>10 meters (grade ≥ 3 on GBS DS).
. IVIg treatment being considered.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 1 Grade
Timeframe: Baseline to Day 360
2
Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 2 Grades
Timeframe: Baseline to Day 360
3
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Timeframe: Baseline to Day 360
4
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
. Women of child-bearing potential willing or able to use at least one highly effective contraceptive method from the day of treatment until at least 6 months after the dose of imlifidase if not abstinent. In the context of this study, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
Exclusion criteria
. Previous treatment with imlifidase.
. Previous IVIg treatment within 28 days prior to imlifidase treatment.
. Subjects who are being considered for, or already on, PE.
. Women of child-bearing potential willing or able to use at least one highly effective contraceptive method from the screening visit until at least 180 days following imlifidase dosing.
. Breastfeeding or pregnancy
. Clinical evidence of a polyneuropathy of another cause e.g. diabetes mellitus (except mild sensory), alcoholism, vitamin deficiency, or porphyria.
. Known selective immunoglobulin A (IgA) deficiency.
. Hypersensitivity to IVIg or to any of the excipients.
Change From Baseline in R-ODS Over Time
Timeframe: Baseline to Day 360
9
Days in Hospital
Timeframe: Baseline to Day 360
10
Time in an ICU
Timeframe: Baseline until Day 360
11
Need for Mechanical Ventilation
Timeframe: Baseline until Day 180
12
Patient's Health State Over Time as Assessed by EQ VAS
Timeframe: Day 8, Day 15, Day 29, Day 57, Day 92, Day 180, and Day 360