Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ANX005 · 5 trials · 5 indications
Number participants recently diagnosed with GBS who experience adverse events.
An adverse event (AE) was any untoward medical occurrence in a participant who had been administered a pharmaceutical product. An AE did not necessarily have a causal relationship with the product and therefore could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product. An AE could arise with any use, route of administration, formulation, dose (including an overdose), or when used in combination with another pharmaceutical product. A TEAE was an AE with an onset date/time after the first infusion of ANX005 until the end of the study. A summary of serious and all other non-serious adverse events regardless of causality is located in the Adverse Events module.
Maximum change from Baseline was calculated as the maximum post-Baseline value observed up to Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.
Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.
Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.
Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.
Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.
Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.
As measured by incidence of TEAEs, SAEs, AEs related to ANX005, SAEs related to ANX005, Grade 3 or higher AEs, Grade 3 or higher AEs related to ANX005, AEs leading to study or treatment discontinuation.
As measured by ANX005 serum and cerebrospinal fluid concentrations
As measured by C1q, C4a, and NfL levels in blood and/or cerebrospinal fluid concentrations
As measured by incidence of TEAEs, SAEs, AE's related to ANX005, SAE's related to ANX005, Grade 3 or higher AEs, Grade 3 or higher AEs related to ANX005, AEs leading to study or treatment discontinuation.
| Arm | Type | Description |
|---|---|---|
| ANX005 Treatment Group - Dose 1 | EXPERIMENTAL | Participants will receive a single IV infusion of ANX005 (Dose 1) on Day 1. |
| ANX005 Treatment Group - Dose 2 | EXPERIMENTAL | Participants will receive a single IV infusion of ANX005 (Dose 2) on Day 1. |
| Placebo Group | PLACEBO_COMPARATOR | Participants will receive a single IV infusion of placebo on Day 1. |
| ANX005 | EXPERIMENTAL | Participants will receive two once-weekly doses of ANX005 at specific time points |
| Open Label Treatment Arm | EXPERIMENTAL | One (1) dose of ANX005, 75 mg/kg, will be administered IV. IVIg, 0.4 g/kg, will be administered for 5 consecutive Days. |
| Name | Type | Description |
|---|---|---|
| ANX005 | DRUG | Solution for intravenous infusion |
| Placebo | DRUG | Solution for intravenous infusion |
| Intravenous immunoglobulin | DRUG | investigational drug |
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 infusi...