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| Name | Class |
|---|---|
| ResearchPoint Global | OTHER |
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANX005 | Drug | investigational drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of ANX005 when administered in combination with IVIg | As measured by ANX005 serum concentrations | 3 months |
| Pharmacodynamics of ANX005 when administered in combination with IVIg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henk-André Kroon, MD, MBA | Annexon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Neurosciences and Hospital | Dhaka | Bangladesh | ||||
| Aarhus University Hospital |
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| ID | Term |
|---|---|
| D020275 | Guillain-Barre Syndrome |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Open label combination treatment
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| Intravenous immunoglobulin | Drug | investigational drug |
|
|
As measured by CH50 and C1q serum concentrations
| 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 | 6 months |
| Aarhus |
| Denmark |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |