A phase 2 multicenter study of ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis.

ABSTRACT:

Background

Ublituximab, a novel monoclonal antibody (mAb) targeting a unique epitope on the CD20 antigen, is glycoengineered for enhanced B-cell targeting through antibody-dependent cellular cytotoxicity (ADCC). Greater ADCC may allow lower doses and shorter infusion times versus other anti-CD20 mAbs.

Objective

The objective was to determine optimal dose, infusion time, and activity of ublituximab in relapsing multiple sclerosis.

Methods

This is a phase 2, placebo-controlled study. Patients received three ublituximab infusions (150 mg over 1-4 hours on day 1 and 450-600 mg over 1-3 hours on day 15 and week 24) in six dosing cohorts. The primary endpoint was B-cell depletion.

Results

In all cohorts (N = 48), median B-cell depletion was >99% by week 4, mai

SUBMITTER: Fox E 

PROVIDER: S-EPMC7897779 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature