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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Administered as an intravenous (IV) infusion.
Oral capsule.
IV infusion.
Oral capsule.
Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab
Time frame: Predose and multiple timepoints up to Week 24
Part A: Maximum Observed Concentration (Cmax) of Ublituximab
Time frame: Day 1 and Day 15
Part A: Participant B Cell Counts
Time frame: Up to Week 24
Part B: Annualized Relapse Rate (ARR)
Time frame: Up to 96 weeks
Part C: Annualized Relapse Rate (ARR)
Time frame: Up to 168 weeks
Part A, B and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: 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 )
Time frame: Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks
Part A: Serum Concentrations of Ublituximab
Time frame: Up to Week 24
Part A and B: Percentage of Participants with Treatment-emergent Anti-drug Antibodies (ADAs) to Ublituximab
Time frame: 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
Time frame: 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
Time frame: Part A: Up to Week 24; Part B: Up to 96 weeks
Past A: Annualized Relapse Rate
Time frame: Up to Week 24
Part A and C: Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Time frame: Part A: Baseline, up to Week 24; Part C: Baseline, up to 168 weeks
Part B: Pharmacokinetics (PK) Serum Concentration of Ublituximab
Time frame: Up to Week 96
Part B: Percentage of Participants with CD19+ B cell counts ≤10 cells/uL
Time frame: Up to 96 weeks
Part B: Annualized Relapse Rate ARR
Time frame: Up to Week 96
Part C: Time to Confirmed Disability Progression (CDP)
Time frame: Up to Week 24
Part C: Time to Confirmed Disability Improvement (CDI)
Time frame: Up to Week 24
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