This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS.
The study will enroll approximately 12 subjects into one cohort, with subjects receiving 75 mg/kg of ANX005, a dose shown to be safe and well-tolerated as monotherapy and that provides a meaningful level of exposure to be tested in combination with IVIg. Dosing of IVIg will be administered as is the current standard of care (0.4 g/kg/day x 5 days) and ANX005 will be administered concurrently, beginning on Day 1 or 2 of the treatment period. Subjects will be followed for 6 months after treatment for observation and evaluation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
investigational drug
investigational drug
National Institute of Neurosciences and Hospital
Dhaka, Bangladesh
Aarhus University Hospital
Aarhus, Denmark
Safety and tolerability of ANX005 when administered in combination with IVIg: incidence of TEAEs, SAEs, AE's
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.
Time frame: 6 months
Pharmacokinetics of ANX005 when administered in combination with IVIg
As measured by ANX005 serum concentrations
Time frame: 3 months
Pharmacodynamics of ANX005 when administered in combination with IVIg
As measured by CH50 and C1q serum concentrations
Time frame: 4 months
Values and change from baseline in Guillain-Barré Syndrome Disability Score (GBS-DS) by visit
The 6-point Guillain-Barré Syndrme Disability Score (GBS-DS) is a widely accepted and easily obtainable scoring system used to assess functional status of GBS subjects. The score is as follows: 0 = Healthy, 1 = Minor symptoms and capable of running, 2 = Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4 = Bedridden or chair bound, 5 = Needing mechanical ventilation, 6 = death
Time frame: 6 months
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