CompletedPhase 1

A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)

Bangladesh, Denmark14 participantsStarted 2020-01-29

Plain-language summary

This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects 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: * Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for Guillain Barré Syndrome * Onset of GBS-related weakness ≤14 days prior to infusion * GBS-DS score of 3, 4, or 5 Exclusion Criteria: * Clinically significant findings that may interfere with the conduct of the study or the interpretation of the data * Be at risk of suicide or self-harm * Received previous treatment with plasma exchange for GBS * Any diagnosis of a variant of GBS * Have a history of anaphylaxis or severe systemic response to immunoglobulin * Documented, clinically significant, pre-existing polyneuropathy from another cause * Clinically significant intercurrent illness, medical condition, or medical history * History of chronic use of steroid or immunosuppressant medication * Active alcohol, drug, or substance abuse * Females who are pregnant, breast feeding, or unable or unwilling to use highly effective methods of contraception throughout the study

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

Safety and tolerability of ANX005 when administered in combination with IVIg: incidence of TEAEs, SAEs, AE's

Timeframe: 6 months

Trial details

NCT IDNCT04035135

SponsorAnnexon, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-19

View on ClinicalTrials.gov More Guillain-Barré Syndrome trials

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.