A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)

A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07211633

Enrollment

360

Registered

2025-10-08

Start date

2025-07-09

Completion date

2028-12-31

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Multiple Sclerosis

Brief summary

The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.

Detailed description

This is a Phase 3, open label, parallel-group, multicenter study in participants with RMS.

Interventions

BIOLOGICALUblituximab

Administered as an IV infusion.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Diagnosis of RMS (2017 Revised McDonald criteria). 2. Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening. 3. Neurologically stable for \> 30 days prior to Screening and Day 1. 4. Female participants of childbearing potential must consent to use a highly effective method of contraception from consent and for 6 months after the last dose of ublituximab.

Exclusion criteria

1. Primary-progressive Multiple Sclerosis (PPMS) or inactive Secondary Progressive Multiple Sclerosis (SPMS). 2. Active chronic disease of the immune system other than MS or immunodeficiency syndrome. 3. Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia. 4. Participants who previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening. Note: Other Inclusion/

Design outcomes

Primary

Measure	Time frame
Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab	Up to Week 24

Secondary

Measure	Time frame
Minimum Plasma Concentration (Cmin) of Ublituximab	Up to Week 24
Average Concentration at Steady State (Cavg,ss) of Ublituximab	Up to Week 120
Maximum Plasma Concentration (Cmax) of Ublituximab	Up to Week 120
Time to Maximum Plasma Concentration (Tmax) of Ublituximab	Up to Week 120
Last Observed Concentration (Clast) of Ublituximab	Up to Week 120
Area Under the Curve From Week 0 to Week 120 (AUC0-120) of Ublituximab	Up to Week 120
Concentration From Time 0 to Time of Last Concentration (AUClast) of Ublituximab	Up to Week 120
Time of Last Concentration (Tlast) of Ublituximab	Up to Week 120
Participants B Cell Counts	Up to Week 120
Incidence of Treatment Emergent Adverse Events (TEAEs)	Up to Week 120
Total Number of Gadolinium (Gd) enhancing T1 Lesions Per Magnetic Resonance Imaging (MRI) Scan	Up to Week 96
Total Number of New or Enlarging T2 lesions Per MRI Scan	Up to Week 96

Countries

Bosnia and Herzegovina, Bulgaria, Croatia, Czechia, Georgia, Hungary, North Macedonia, Serbia, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026