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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANX005 | Drug | Solution for intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| GBS Disability Score (GBS-DS) at Week 8 | Week 8 | |
| Number of Participants with Adverse Events | Number participants recently diagnosed with GBS who experience adverse events. | Through Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Medical Research Council (MRC) Sum Score at Week 8 | Week 8 | |
| MRC Sum Score at Day 8 | Day 8 | |
| Duration (Days) of Ventilation Support Over 26 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Annexon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhaka Medical Center | Dhaka | Bangladesh | ||||
| National Institute of Neurosciences and Hospital (NINS) |
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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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| Placebo | Drug | Solution for intravenous infusion |
|
| 26 weeks |
| GBS Disability Score (GBS-DS) | Week 26 |
| Number of Participants Requiring Intensive Care Unit Stay | 26 weeks |
| Duration (Days) of Intensive Care Unit Stays | 26 weeks |
| Patient Global Impression of Change Scores | Week 8 and Week 26 |
| Dhaka |
| Bangladesh |
| Baguio General Hospital Medical Center | Baguio City | Philippines |
| Batangas Medical Center | Batangas | Philippines |
| Mary Mediatrix Medical Center | Batangas | Philippines |
| Perpetual Succour Hospital | Cebu City | Philippines |
| Cotabato Regional Medical Center | Cotabato City | Philippines |
| Southern Philippines Medical Center | Davao City | Philippines |
| Jose R. Reyes Memorial Medical Center | Manila | Philippines |
| West Visayas State University Medical Center | Manila | Philippines |
| Zamboanga City Medical Center | Zamboanga City | Philippines |
| 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 |