A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis

Phase 3 Completed 111 enrolled Novartis Pharmaceuticals

NaSingle-groupOpen-labelTreatment

Summary

A single arm study evaluating the continued efficacy, safety and tolerability of ofatumumab in patients with relapsing multiple sclerosis who are transitioning from aCD20 mAb therapy

Timeline

Start: 2020-10-19
Primary completion: 2023-11-20
Completion: 2024-10-21

Outcome

Met primary endpoint

paper Zero Gd+ T1 lesions were observed at Month 12 in participants with evaluable MRI assessments (n = 84), satisfying the primary endpoint. PMID 41196386 ↗

Publications

Hua LH, Brown B, Camacho E, Chinea AR, Greenberg BM, Henry RG, Houtsma E, Moreo N, Alvarez E. Switch from intravenous anti-CD20 therapy to subcutaneous ofatumumab in patients with relapsing MS: results from the OLIKOS study. J Neurol. 2025 Oct 24;272(11):725. doi: 10.1007/s00415-025-13462-w.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ofatumumab	Monoclonal antibody	20 mg	Subcutaneous