Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis

NCT07220252 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: TG1101-RMS-PED3042025-522257-19-00
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (13)

• 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

Study Arms (6)

Part A: Ublituximab

EXPERIMENTAL

New Regimen

Drug: Ublituximab

Part B: Ublituximab

EXPERIMENTAL

New Regimen

Drug: Ublituximab

Part B: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Part B: Fingolimod

EXPERIMENTAL

Drug: Fingolimod

Part B: IV Placebo

PLACEBO COMPARATOR

Drug: Placebo

Part C: OLE

EXPERIMENTAL

Drug: Ublituximab

Interventions

Ublituximab DRUG

Administered as an intravenous (IV) infusion.

Also known as: TG-1101, BRIUMVI

Part A: Ublituximab; Part B: Ublituximab; Part C: OLE

Placebo DRUG

Oral capsule.

Part B: Placebo

Fingolimod DRUG

Oral capsule.

Part B: Fingolimod

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• \. Participants must have completed Part A (Week 24 visit) or Part B (Week 96 visit) to be eligible for Part C.

You may not qualify if:

• 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.
• Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time.
• The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics.
• \. If the absolute lymphocyte count (ALC) is outside the specified range the participant will not be eligible to receive ublituximab in Part C.

Sponsors & Collaborators

• TG Therapeutics, Inc.: lead

MeSH Terms

Interventions

ublituximab; Fingolimod Hydrochloride

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Central Study Contacts

TG Therapeutics Clinical Support Team

CONTACT

1-877-575-8489; clinicalsupport@tgtxinc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: October 23, 2025
• Study Start: March 31, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): June 30, 2033
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share