Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ublituximab, Placebo, Placebo, Fingolimod.
- Who it may be relevant to
- Registry conditions: Relapsing Multiple Sclerosis. Basic parameters: 10 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
Overview
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
- Drug Ublituximab
Administered as an intravenous (IV) infusion. - Drug Placebo
Oral capsule. - Drug Placebo
IV infusion. - Drug Fingolimod
Oral capsule.
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion Criteria for Part A and Part B:
- Diagnosis of RMS.
- EDSS at screening: 0-5.5, inclusive.
- 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:
- Known presence or suspicion of other neurologic disorders that may mimic MS.
- Prior treatments:
- 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).
- High dose intravenous immunoglobulin (IVIG) or subcutaneous IG (SCIG) within 2 months prior to W1D1.
- Treatment with anti-CD20 or other B cell directed treatment at any time.
- Treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone at any time.
Additional Exclusion Criteria for Part B Only (Relevant to Fingolimod Treatment):
- Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time.
- The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics.
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Poland · 2 centers
- TG Therapeutics Investigational Trial Site — Gdansk
- TG Therapeutics Investigational Trial Site — Poznan
Identifiers
NCT: NCT07220252 · TG1101-RMS-PED304 · 2025-522257-19-00