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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522664-32-00 | EU Trial (CTIS) Number |
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The goal of this open label study is to measure pharmacokinetics, pharmacodynamics, early efficacy, and safety of tanruprubart in adult and pediatric participants, in the United States, Canada, and Europe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tanruprubart | Experimental | Participants will receive a single 30 mg/kg intravenous (IV) infusion of tanruprubart on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tanruprubart | Drug | Solution for IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Tanruprubart Serum Concentration-time Curve to the Last Sample (AUC0-t) | Up to Day 15 | |
| Observed Time to Maximum Observed Serum Concentration (Cmax) (Tmax) of Tanruprubart | Up to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Free Component of Complement Complex (C1q) Protein Concentration in Serum | Baseline up to Day 15 | |
| Change from Baseline in Medical Research Council (MRC) Sumscore at Week 1 | Baseline, Week 1 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 1-650-822-5500 | clinicaltrials@annexonbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Annexon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital & Medical Center - Barrow Neurological Institute | Recruiting | Phoenix | Arizona | 85013 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| HonorHealth Bob Bové Neuroscience Institute | Recruiting | Scottsdale | Arizona | 85251 | United States |
| Profound Research LLC | Recruiting | Carlsbad | California | 92011 | United States |
| Children's Hospital of Orange County | Recruiting | Orange | California | 92868 | United States |
| University of California Irvine | Recruiting | Orange | California | 92868 | United States |
| University of Colorado Hospital | Recruiting | Aurora | Colorado | 80045 | United States |
| Mayo Clinic Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
| Ochsner LSU Health | Recruiting | Shreveport | Louisiana | 71101 | United States |
| University Massachusetts Chan Medical School | Recruiting | Worcester | Massachusetts | 01655 | United States |
| Henry Ford Health | Recruiting | Detroit | Michigan | 48202 | United States |
| Mayo Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
| Aarhus University Hospital | Recruiting | Aarhus | Aarhus N | 8200 | Denmark |
| ID | Term |
|---|---|
| D020275 | Guillain-Barre Syndrome |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| 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 |
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