Relapsing Multiple Sclerosis
Conditions
Brief summary
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).
Interventions
DRUGUblituximab
Administered as an intravenous (IV) infusion.
DRUGPlacebo
Oral capsule.
DRUGFingolimod
Oral capsule.
Sponsors
TG Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
for Part A and Part B: 1. Diagnosis of RMS. 2. EDSS at screening: 0-5.5, inclusive. 3. Neurologic stability for ≥ 30 days prior to screening, and between screening and Week 1 Day 1 (W1D1). 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: 1. Known presence or suspicion of other neurologic disorders that may mimic MS. 2. Prior treatments: 1. Systemic corticosteroids (\>0.1 milligrams/kilogram/day \[mg/kg/day\], or \>5 milligrams/day \[mg/day\] of prednisone equivalent) or adrenocorticotropic hormone (ACTH) within 30 days prior to the screening MRI scan (note: Topical, ophthalmic, or inhaled corticosteroids are permitted). 2. High dose intravenous immunoglobulin (IVIG) or subcutaneous IG (SCIG) within 2 months prior to W1D1. 3. Treatment with anti-CD20 or other B cell directed treatment at any time. 4. Treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone at any time. Additional
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 ) | 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 |
Countries
Poland
Contacts
CONTACTTG Therapeutics Clinical Support Team
Outcome results
None listed