A phase 2 multicenter study of ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis.
TG-1101
Ublituximab
gadolinium-enhancing lesions
magnetic resonance imaging
multiple sclerosis
relapse
Journal
Multiple sclerosis (Houndmills, Basingstoke, England)
ISSN: 1477-0970
Titre abrégé: Mult Scler
Pays: England
ID NLM: 9509185
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
pubmed:
1
5
2020
medline:
25
9
2021
entrez:
1
5
2020
Statut:
ppublish
Résumé
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. The objective was to determine optimal dose, infusion time, and activity of ublituximab in relapsing multiple sclerosis. 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. In all cohorts ( Ublituximab was safely infused as rapid as 1 hour, producing robust B-cell depletion and profound reductions in magnetic resonance imaging (MRI) activity and relapses.
Sections du résumé
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 (
CONCLUSION
Ublituximab was safely infused as rapid as 1 hour, producing robust B-cell depletion and profound reductions in magnetic resonance imaging (MRI) activity and relapses.
Identifiants
pubmed: 32351164
doi: 10.1177/1352458520918375
pmc: PMC7897779
doi:
Substances chimiques
Antibodies, Monoclonal
0
Antigens, CD20
0
ublituximab
U59UGK3IPC
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
420-429Références
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