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

NCT07220252Phase 2/3Recruiting

Lead sponsor
TG Therapeutics, Inc. (Industry)
Enrollment
240 (estimated)
Start date
1 Jul 2026
Primary completion
1 Jan 2030 (estimated)
Study completion
30 Jun 2033
Last update posted
29 Oct 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
6

Interventions

  • Ublituximab Drug
  • Placebo Drug
  • Fingolimod Drug

Conditions and primary outcome

  • Relapsing Multiple Sclerosis

Primary outcome

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)

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT07220252.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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