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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age10-17
SponsorTG Therapeutics, Inc.

About this trial

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).

Eligibility criteria

Qualifiers

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).

Disqualifiers

Known presence or suspicion of other neurologic disorders that may mimic MS.

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.

Trial design

Treatments tested in this trial

  • Ublituximab
  • Placebo
  • Placebo
  • Fingolimod

Treatment groups

240 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators