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NCT Number: NCT07220252

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

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).

Recruiting

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Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

TG Therapeutics Investigational Trial Site, Gdansk, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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:

  • 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

Treatment and study plan

Ublituximab

Drug

Administered as an intravenous (IV) infusion.

Other names: TG-1101, BRIUMVI

Placebo

Drug

Oral capsule.

Fingolimod

Drug

Oral capsule.

Primary outcomes

  1. 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

  2. Part A: Maximum Observed Concentration (Cmax) of Ublituximab

    Time frame: Day 1 and Day 15

  3. Part A: Participant B Cell Counts

    Time frame: Up to Week 24

  4. Part B: Annualized Relapse Rate (ARR)

    Time frame: Up to 96 weeks

  5. Part C: Annualized Relapse Rate (ARR)

    Time frame: Up to 168 weeks

Secondary outcomes

  1. 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

  2. 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

  3. Part A: Serum Concentrations of Ublituximab

    Time frame: Up to Week 24

  4. 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

  5. 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

  6. 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

  7. Past A: Annualized Relapse Rate

    Time frame: Up to Week 24

  8. 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

  9. Part B: Pharmacokinetics (PK) Serum Concentration of Ublituximab

    Time frame: Up to Week 96

  10. Part B: Percentage of Participants with CD19+ B cell counts ≤10 cells/uL

    Time frame: Up to 96 weeks

  11. Part B: Annualized Relapse Rate ARR

    Time frame: Up to Week 96

  12. Part C: Time to Confirmed Disability Progression (CDP)

    Time frame: Up to Week 24

  13. Part C: Time to Confirmed Disability Improvement (CDI)

    Time frame: Up to Week 24

Study contacts

Contact information is provided by the study sponsor or research team.

TG Therapeutics Clinical Support Team

CONTACT

[email protected]

1-877-575-8489

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Registry information

Official study title

Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)

Important dates

Study start
2026
Primary completion
2030
Study completion
2033
First posted
Oct 23, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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