How many clinical trials are studying Ublituximab?

9 recruiting trials in our tracked data involve Ublituximab.

What conditions is Ublituximab being studied for?

In our tracked recruiting trials, Ublituximab is being studied in trials for Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Relapsing Multiple Sclerosis.

Ublituximab: clinical trials recruiting now

Q: Is Ublituximab FDA-approved?

Yes. According to the FDA drug label available through openFDA, Ublituximab is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Ublituximab appears in the FDA drug-label database. Marketed as BRIUMVI.
Drug class: CD20-directed Cytolytic Antibody (FDA established pharmacologic class)
Mechanism of action: CD20-directed Antibody Interactions (as stated on the FDA label)

FDA-approved use

BRIUMVI is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BRIUMVI is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 , 14 ).

FDA label via openFDA

Phase breakdown

Early Phase 1 1 Phase 2 3 Phase 3 2 Phase 4 2 Not applicable 2

Conditions being studied

Condition	Trials
Multiple Sclerosis · Ublituximab for Multiple Sclerosis	8
Multiple Sclerosis (MS) - Relapsing-remitting · Ublituximab for Multiple Sclerosis (MS) - Relapsing-remitting	3
Relapsing Multiple Sclerosis	2
Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis	1
Schizophrenia	1

Recruiting trials involving Ublituximab

A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
NCT06681623 · Phase: Not specified · Ages: 55 Years to 80 Years · Sex: All (male and female) · 1 location
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
NCT07503873 · Phase: Phase 2 · Ages: 18 Years to 65 Years · Sex: All (male and female) · 39 locations
Effects of Ublituximab on Motor Functions in Multiple Sclerosis
NCT06629428 · Phase: Early Phase 1 · Ages: 18 Years to 55 Years · Sex: All (male and female) · 2 locations
Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis
NCT06864936 · Phase: Not applicable (e.g. observational or device study) · Ages: 18 Years to 65 Years · Sex: All (male and female) · 1 location
Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis
NCT07389590 · Phase: Phase 4 · Ages: 18 Years to 65 Years · Sex: All (male and female) · 1 location
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
NCT07220252 · Phase: Phase 2, Phase 3 · Ages: 10 Years to 17 Years · Sex: All (male and female) · 2 locations
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
NCT05877963 · Phase: Phase 3 · Ages: 18 Years to 65 Years · Sex: All (male and female) · 51 locations
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
NCT07680946 · Phase: Phase 2 · Ages: 18 Years to 60 Years · Sex: All (male and female) · 2 locations
Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
NCT07225361 · Phase: Phase 4 · Ages: 18 Years to 70 Years · Sex: All (male and female) · 1 location

Common questions

Is Ublituximab FDA-approved?

Yes, marketed as BRIUMVI.

How many recruiting trials involve Ublituximab?

9 recruiting trials across 5 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.