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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523757-33-00 | Other Identifier | EU CT Number |
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The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with an AI device versus syringe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Ublituximab SC | Experimental | Participants will receive ublituximab SC, using a syringe at one of three different sites of administration. |
|
| Part 2: Ublituximab SC | Experimental | Participants will be randomized to receive ublituximab SC using either the AI device or a syringe. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ublituximab | Drug | Administered as an SC injection by a syringe. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Area under the curve (AUC) From Week 0 to Week 12 [AUC(0-W12)] of Ublituximab | Up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Plasma Concentrations of Ublituximab | Up to Week 24 | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to Week 120 | |
| Part 2: Percentage of Participants Reporting Their Level of Satisfaction With the SC Method of Administration of Ublituximab, Assessed by Therapy Administration Satisfaction Questionnaire-Subcutaneous (TASQ-SC) |
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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 | Bihać | 77000 | Bosnia and Herzegovina | ||
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| Ublituximab | Drug | Administered as an SC injection by AI device. |
|
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| AI device | Device | Ublituximab will be administered as an SC injection by AI device. |
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| Up to Week 96 |
| Part 2: Minimum Plasma Concentration (Cmin) of Ublituximab | Up to Week 12 |
| TG Therapeutics Investigational Trial Site |
| Recruiting |
| Sarajevo |
| 71000 |
| Bosnia and Herzegovina |
| TG Therapeutics Investigational Trial Site | Recruiting | Tuzla | 75000 | Bosnia and Herzegovina |
| TG Therapeutics Investigational Trial Site | Recruiting | Zenica | 72000 | Bosnia and Herzegovina |
| TG Therapeutics Investigational Trial Site | Recruiting | Tbilisi | 101 | Georgia |
| TG Therapeutics Investigational Trial Site | Recruiting | Tbilisi | 114 | Georgia |
| TG Therapeutics Investigational Trial Site | Recruiting | Tbilisi | 159 | Georgia |
| TG Therapeutics Investigational Trial Site | Recruiting | Tbilisi | 179 | Georgia |
| TG Therapeutics Investigational Trial Site | Recruiting | Bydgoszcz | 85-796 | Poland |
| TG Therapeutics Investigational Trial Site | Recruiting | Katowice | 40-686 | Poland |
| TG Therapeutics Investigational Trial Site | Recruiting | Kielce | 25-726 | Poland |
| TG Therapeutics Investigational Trial Site | Recruiting | Lodz | 90-324 | Poland |
| TG Therapeutics Investigational Trial Site | Recruiting | Poznan | 61-853 | Poland |
| TG Therapeutics Investigational Trial Site | Recruiting | Warsaw | 04-141 | Poland |
| TG Therapeutics Investigational Trial Site | Recruiting | Belgrade | 11000 | Serbia |
| TG Therapeutics Investigational Trial Site | Recruiting | Kragujevac | 34 000 | Serbia |
| TG Therapeutics Investigational Trial Site | Recruiting | Chernihiv | 14001 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Chernihiv | 14029 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Ivano-Frankivsk | 76008 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Ivano-Frankivsk | 76018 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Ivano-Frankivsk | 76493 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Kyiv | 2000 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Kyiv | 2091 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Kyiv | 3037 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Kyiv | 3110 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Kyiv | 4050 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Kyiv | 4211 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Lviv | 79010 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Lviv | 79029 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Odesa | 65009 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Poltava | 36011 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Tbilisi | 159 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Ternopil | 46014 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Uzhhorod | 88018 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Vinnytsia | 21001 | Ukraine |
| TG Therapeutics Investigational Trial Site | Recruiting | Vinnytsia | 21009 | Ukraine |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000619007 | ublituximab |
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