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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515157-17-00 | Other Identifier | EUCT | |
| ALXN1720-MG-302 | Other Identifier | Alexion | |
| U1111-1327-6615 | Other Identifier | WHO |
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The primary objective of this study is to assess the pharmacokinetics and pharmacodynamics of gefurulimab in pediatric participants with AChR+ gMG for the duration of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefurulimab | Experimental | On Day 1, participants will receive a weight based loading dose followed by a weekly maintenance dose for up to 122 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefurulimab | Combination Product | Combination product consisting of syringe prefilled with gefurulimab will be administered weekly via subcutaneous (SC) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Gefurulimab | Day 1 predose through Week 18 predose | |
| Serum Free Complement Component 5 (C5) Concentration | Day 1 predose through Week 18 predose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Day 1 through Week 134 | |
| Change in Quantitative Myasthenia Gravis Score for Disease Severity (QMG) Total Score From Baseline Through Week 18 |
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Inclusion Criteria:
United States of America (USA) specific inclusion criterion:
Rest of World (ROW) specific inclusion criteria:
Global inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. (Sponsor) | Contact | 1-855-752-2356 | clinicaltrials@alexion.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Washington D.C. | District of Columbia | 20010 | United States | |
Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
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| Baseline through Week 18 |
| Number of Participants With ≥ 5-point Reduction From Baseline in the QMG Total Score Through Week 18 | Baseline through Week 18 |
| Change in Myasthenia Gravis Activities of Daily Living Profile (MG-ADL) Total Score From Baseline Through Week 18 | Baseline through Week 18 |
| Number of Participants With ≥ 3-point Reduction From Baseline in the MG-ADL Total Score Through Week 18 | Baseline through Week 18 |
| Number of Participants With Anti-drug Antibodies (ADAs) | Baseline through Week 134 |
| Number of ADA Positive Participants With Pre-existing Immunoreactivity,Treatment-emergent or Treatment-boosted ADA Responses | Baseline through Week 134 |
| Number of ADA Positive Participants With Neutralizing Antibody (NAb) Positive or Negative Status | Baseline through Week 134 |
| Research Site |
| Recruiting |
| Norfolk |
| Virginia |
| 23507 |
| United States |
| Research Site | Recruiting | Joinville | 89202-451 | Brazil |
| Research Site | Recruiting | Salvador | 41253-190 | Brazil |
| Research Site | Recruiting | São José do Rio Preto | 15090-000 | Brazil |
| Research Site | Recruiting | São Paulo | 0438-002 | Brazil |
| Research Site | Recruiting | São Paulo | 05403-000 | Brazil |
| Research Site | Recruiting | Saitama-Shi | 330-8777 | Japan |
| Research Site | Withdrawn | Bydgoszcz | 85-065 | Poland |
| Research Site | Withdrawn | Lodz | 93-338 | Poland |
| Research Site | Recruiting | Warsaw | 02-097 | Poland |
| Research Site | Recruiting | New Taipei City | 23561 | Taiwan |
| Research Site | Recruiting | Taipei | 11101 | Taiwan |
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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