Ublituximab in Pediatric Relapsing MS: See if a B-cell therapy works in kids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pediatric interventional study evaluating ublituximab in children aged 10 to under 18 with relapsing MS. Part A looks at how the drug behaves in the body and its biological effects, Part B compares ublituximab to fingolimod for non-inferiority, and Part C follows long-term safety and effectiveness after initial treatment. Participants must have stable neurologic status and certain MS-related criteria, with specific contraindications guiding eligibility. Dosing involves active treatment and placebo controls in different parts, with constraints on prior therapies and recent high-dose immunosuppression. The trial is conducted at multiple TG Therapeutics investigational sites in the United States and Europe.

Why it matters

Who can join: the full rules

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 Exclusion Criteria for Part B Only (Relevant to Fingolimod Treatment):

1. Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time.
2. 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

Where it's running

• TG Therapeutics Investigational Trial Site
  Salt Lake City, Utah, United States Recruiting
• TG Therapeutics Investigational Trial Site
  Gdansk, Poland Recruiting
• TG Therapeutics Investigational Trial Site
  Rzeszów, Poland Recruiting
• TG Therapeutics Investigational Trial Site
  Warsaw, Poland Recruiting
• TG Therapeutics Investigational Trial Site
  Bratislava, Slovakia Recruiting
• TG Therapeutics Investigational Trial Site
  Poznan, Poland Not yet recruiting

Study contacts

• Study coordinator: TG Therapeutics Clinical Support Team
• Email: clinicalsupport@tgtxinc.com
• Phone: 1-877-575-8489

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.