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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522257-19-00 | Other Identifier | EU CT Number |
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The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Ublituximab | Experimental | New Regimen |
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| Part B: Ublituximab | Experimental | New Regimen |
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| Part B: Placebo | Placebo Comparator |
| |
| Part B: Fingolimod | Experimental |
| |
| Part B: IV Placebo | Placebo Comparator |
| |
| Part C: OLE | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ublituximab | Drug | Administered as an intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab | Predose and multiple timepoints up to Week 24 | |
| Part A: Maximum Observed Concentration (Cmax) of Ublituximab | Day 1 and Day 15 | |
| Part A: Participant B Cell Counts | Up to Week 24 | |
| Part B: Annualized Relapse Rate (ARR) | Up to 96 weeks | |
| Part C: Annualized Relapse Rate (ARR) | Up to 168 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part A, B and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks | |
| Part A, B and C: Number of Participants With Change in Columbia-Suicide Severity Rating Scale (C-SSRS ) |
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Inclusion Criteria for Part A and Part B:
Inclusion Criteria for Part C:
1. Participants must have completed Part A (Week 24 visit) or Part B (Week 96 visit) to be eligible for Part C.
Exclusion Criteria for Part A and B:
Known presence or suspicion of other neurologic disorders that may mimic MS.
Prior treatments:
Additional Exclusion Criteria for Part B Only (Relevant to Fingolimod Treatment):
Exclusion Criteria for Part C:
1. If the absolute lymphocyte count (ALC) is outside the specified range the participant will not be eligible to receive ublituximab in Part C.
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 | Poznan | 60-355 | Poland |
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| ID | Term |
|---|---|
| C000619007 | ublituximab |
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Oral capsule. |
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| Placebo | Drug | IV infusion. |
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| Fingolimod | Drug | Oral capsule. |
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| Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks |
| Part A: Serum Concentrations of Ublituximab | Up to Week 24 |
| Part A and B: Percentage of Participants with Treatment-emergent Anti-drug Antibodies (ADAs) to Ublituximab | Part A: Up to Week 24; Part B: Up to 96 weeks |
| Part A and B: Number of Gadolinium Enhancing (Gd-enhancing) T1 Lesions per Magnetic Resonance Imaging (MRI) Scan | Part A: Up to Week 24; Part B: Up to 96 weeks |
| Part A and B: Number of New and/or enlarging T2 Hyperintense Lesions (NELs) per MRI Scan | Part A: Up to Week 24; Part B: Up to 96 weeks |
| Past A: Annualized Relapse Rate | Up to Week 24 |
| Part A and C: Change From Baseline in Expanded Disability Status Scale (EDSS) Score | Part A: Baseline, up to Week 24; Part C: Baseline, up to 168 weeks |
| Part B: Pharmacokinetics (PK) Serum Concentration of Ublituximab | Up to Week 96 |
| Part B: Percentage of Participants with CD19+ B cell counts ≤10 cells/uL | Up to 96 weeks |
| Part B: Annualized Relapse Rate ARR | Up to Week 96 |
| Part C: Time to Confirmed Disability Progression (CDP) | Up to Week 24 |
| Part C: Time to Confirmed Disability Improvement (CDI) | Up to Week 24 |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |