Guillain-Barre Syndrome
Conditions
Brief summary
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.
Interventions
DRUGANX005
Solution for intravenous infusion
DRUGPlacebo
Solution for intravenous infusion
Sponsors
Annexon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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 ≤10 days prior to start of infusion. * GBS-DS score of 3,4, or 5 at screening and at Day 1 prior to infusion.
Exclusion criteria
* Clinically significant findings on the screening electrocardiogram (ECG), laboratory test results, or physical examination that are not specific to GBS that may interfere with the conduct of the study, the interpretation of the data, or increase the participant's risk. * Body weight \<30 kilograms (kg) or \>150 kg at screening. * Unresponsive (inexcitable) nerve conduction study results in all nerves tested during screening. * Previous or intended treatment with either plasma exchange or intravenous immunoglobulin for GBS. * Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff's encephalitis, and overlap syndromes. * History of prior episode of GBS. * GBS-related weakness that improved since symptom onset, including an improvement between screening and Day 1 (baseline).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GBS Disability Score (GBS-DS) at Week 8 | Week 8 | — |
| Number of Participants with Adverse Events | Through Month 6 | Number participants recently diagnosed with GBS who experience adverse events. |
Secondary
| Measure | Time frame |
|---|---|
| Duration (Days) of Ventilation Support Over 26 Weeks | 26 weeks |
| GBS Disability Score (GBS-DS) | Week 26 |
| Medical Research Council (MRC) Sum Score at Week 8 | Week 8 |
| Duration (Days) of Intensive Care Unit Stays | 26 weeks |
| Patient Global Impression of Change Scores | Week 8 and Week 26 |
| Number of Participants Requiring Intensive Care Unit Stay | 26 weeks |
| MRC Sum Score at Day 8 | Day 8 |
Countries
Bangladesh, Philippines
Outcome results
None listed