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This study is a multi-center, open-label study of intravenous (IV) ANX005 in participants with ALS.
In this Phase 2a, multi-center, open label, proof-of-biology study, ANX005 will be administered to participants with ALS.
The study consists of approximately 22 weeks of treatment and approximately 14 weeks of follow-up. All participants will be contacted by phone 6 months after study completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANX005 | Experimental | Participants will receive induction dosing of ANX005 on Days 1 and 5 or 6, followed by maintenance doses of ANX005 every 2 weeks up to Week 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANX005 | Drug | IV Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Treatment-Emergent Adverse Events | Up to Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentrations of ANX005 | Up to Week 36 | |
| Maximum Observed Serum Concentration (Cmax) of ANX005 | Up to Week 36 | |
| Area Under the ANX005 Serum Concentration-Time Curve |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Hoehn, MD, PhD | Annexon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Annexon Investigational Site 04 | Phoenix | Arizona | 85013 | United States | ||
| Annexon Investigational Site 01 |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| Day 1 and Week 22 |
| Change from Baseline in Free Complement (C) 1q Serum Concentrations | Baseline, up to Week 36 |
| Orange |
| California |
| 9492868 |
| United States |
| Annexon Investigational Site 02 | Gainesville | Florida | 32608 | United States |
| Annexon Investigational Site 03 | Tampa | Florida | 33612 | United States |
| Annexon Investigational Site 10 | Edmonton | Alberta | T6G 2R7 | Canada |
| Annexon Investigational Site 09 | Toronto | Ontario | M4N 3M5 | Canada |
| Annexon Investigational Site 07 | Montreal | Quebec | H2X 0A9 | Canada |
| Annexon Investigational Site 08 | Montreal | Quebec | H3A 2B4 | Canada |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |