EligibleTrials
Conditions › Multiple sclerosis › NCT05877963

Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab

Recruiting · NCT05877963 · Interventional (participants receive a specific treatment) · Lead sponsor: TG Therapeutics, Inc.

View the official record on ClinicalTrials.gov →
Multiple sclerosis

Interventions studied

PlaceboUblituximab

What this trial is about

The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.

Who can take part

Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)

Inclusion criteria

Exclusion criteria

Where it is running

51 locations listed across 26 US states.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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