A Phase 3 interventional study of ANX005 and Placebo in Guillain-Barre Syndrome, sponsored by Annexon, Inc.. Completed at 11 sites in 2 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Annexon, Inc. · Phase 3, Interventional, and Treatment
This study is intended to evaluate the efficacy and safety of ANX005 administered by intravenous (IV) infusion to participants recently diagnosed with Guillain-Barré Syndrome (GBS). The total duration of study participation is approximately 6 months.
96 studies on the registry are indexed under Guillain-Barre Syndrome; 28 are open to participants now.
This study's enrollment of 242 is above the median of 50 across 43 interventional studies indexed under Guillain-Barre Syndrome.
Browse Guillain-Barre Syndrome studies →Annexon, Inc. is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single IV infusion of ANX005 (Dose 1) on Day 1.
Drug: ANX005
Participants will receive a single IV infusion of ANX005 (Dose 2) on Day 1.
Drug: ANX005
Participants will receive a single IV infusion of placebo on Day 1.
Drug: Placebo
Solution for intravenous infusion
Solution for intravenous infusion
GBS Disability Score (GBS-DS) at Week 8
Time frame: Week 8
Number of Participants with Adverse Events
Number participants recently diagnosed with GBS who experience adverse events.
Time frame: Through Month 6
Medical Research Council (MRC) Sum Score at Week 8
Time frame: Week 8
MRC Sum Score at Day 8
Time frame: Day 8
Duration (Days) of Ventilation Support Over 26 Weeks
Time frame: 26 weeks
GBS Disability Score (GBS-DS)
Time frame: Week 26
Number of Participants Requiring Intensive Care Unit Stay
Time frame: 26 weeks
Duration (Days) of Intensive Care Unit Stays
Time frame: 26 weeks
Patient Global Impression of Change Scores
Time frame: Week 8 and Week 26
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tanruprubart
Annexon, Inc.