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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523950-15-01 | Other Identifier | EU Trial (CTIS) Number |
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The purpose of this study is to evaluate the pharmacodynamic (PD) effect, safety, and tolerability of Povetacicept in participants with generalized myasthenia gravis (gMG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povetacicept | Experimental | Participants will be randomized to receive one of the two doses of povetacicept for the initial 12 weeks. Eligible participants can receive povetacicept for an additional 96 weeks. |
|
| Placebo | Placebo Comparator | Participants will be randomized to receive placebo matched to povetacicept for the initial 12 weeks. Eligible participants can receive povetacicept for an additional 96 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povetacicept | Drug | Solution for Subcutaneous Injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in Total Immunoglobulin G (IgG) | Baseline and At Week 12 | |
| Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Baseline Up to Week 116 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria will apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Contact | 617-341-6777 | medicalinfo@vrtx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Offices | Recruiting | Boca Raton | Florida | 33428 | United States | |
| SFM Clinical Reseach, LLC |
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
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| Placebo |
| Drug |
Solution for Subcutaneous Injection. |
|
| Recruiting |
| Boca Raton |
| Florida |
| 33487 |
| United States |
| Homestead Associates in Research | Recruiting | Homestead | Florida | 33033 | United States |
| UF Health Jacksonville Respiratory Therapy (PFT and DLCO) | Recruiting | Jacksonville | Florida | 32209 | United States |
| Y & L Advance Health Care, Inc D/B/A Elite Clinical Research - Neurology | Recruiting | Miami | Florida | 33144 | United States |
| Quantix Research | Recruiting | Miami | Florida | 33173 | United States |
| Hawaii Pacific Neuroscience | Recruiting | Honolulu | Hawaii | 96817 | United States |
| HSHS Medical Group - St. Elizabeth's Hospital | Recruiting | O'Fallon | Illinois | 62269 | United States |
| Las Vegas Neurology Center | Recruiting | Las Vegas | Nevada | 89106 | United States |
| Clinical Trials of South Carolina - Neurology | Recruiting | Charleston | South Carolina | 29406 | United States |
| Nerve and Muscle Center of Texas - Neurology | Recruiting | Houston | Texas | 77030 | United States |
| Texas Institute for Neurological Disorders | Recruiting | Sherman | Texas | 75093 | United States |
| Neurology Care Clinic | Recruiting | Waxahachie | Texas | 75165 | United States |
| Eastern Health - Box Hill Hospital | Recruiting | Box Hill | Australia |
| Neurologia Slaska Centrum Medyczne | Recruiting | Katowice | Poland |
| Centrum Medyczne Neuroprotect | Recruiting | Warsaw | Poland |
| ETG Neuroscience | Recruiting | Warsaw | Poland |
| 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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