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

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NCT07220252 · readout in 1,231 d

Sponsored by TG Therapeutics, Inc. (industry) · TGTX — their whole pipeline →.

Phase

Phase 2/3

Status

Recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

240estimated

Sites

Country

Poland

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2026-07-01

actual

When the study began enrolling

Primary completion

2030-01-01

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2033-06-30

estimated

The whole study's end, after follow-up

First posted

2025-10-23

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-17

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Relapsing Multiple Sclerosis

Interventions

Drug: Ublituximab — also filed as TG-1101, BRIUMVI
Drug: Placebo
Drug: Placebo
Drug: Fingolimod

Primary outcomes

what the primary-completion date above is the date OF

Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab

measured Predose and multiple timepoints up to Week 24

Part A: Maximum Observed Concentration (Cmax) of Ublituximab

measured Day 1 and Day 15

Part A: Participant B Cell Counts

measured Up to Week 24

Part B: Annualized Relapse Rate (ARR)

measured Up to 96 weeks

Part C: Annualized Relapse Rate (ARR)

measured Up to 168 weeks

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