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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524630-26-00 | Other Identifier | EU CT Number |
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The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized controlled period (RCP) | Experimental | Responder participants from efgartigimod induction period will be randomised 1:1 ratio to receive either ublituximab or ublituximab matching-placebo intravenous (IV) infusion. |
|
| Open-label period (OLP): Ublituximab | Experimental | Non-responder participants from efgartigimod induction period will receive ublituximab IV infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ublituximab | Drug | Administered as an IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of a Clinical Worsening Event | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Up to Week 72 | |
| Maximum Plasma Concentration (Cmax) of Ublituximab | Up to Week 72 | |
| Proportion of Participants with Cluster of Differentiation 19 + (CD19+) B-cell Counts |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TG Therapeutics Clinical Support Team | Contact | 1-877-575-8489 | clinicalsupport@tgtxinc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TG Therapeutics Investigational Trial Site | Recruiting | Colorado Springs | Colorado | 80919 | United States | |
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| Placebo | Drug | Administered as an IV infusion. |
|
| Up to Week 72 |
| Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score in RCP | The MG-ADL scale focuses on relevant symptoms and functional performance of activities of daily living in participants with MG. The total score varies between 0-24, with higher score indicating more severe disease. | Baseline, Week 24 |
| TG Therapeutics Investigational Trial Site |
| Recruiting |
| Clearwater |
| Florida |
| 33761 |
| United States |
| 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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| ID | Term |
|---|---|
| C000619007 | ublituximab |
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