A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

Phase 4 Completed 63 enrolled Novartis Pharmaceuticals

Non-randomizedParallel-groupOpen-labelTreatment

Summary

To assess whether participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once every 4 weeks (q4) can mount an adequate immune response to inactivated influenza vaccine as measured by humoral responses compared to participants on an iDMT.

Timeline

Start: 2021-01-14
Primary completion: 2023-07-06
Completion: 2023-07-06

Publications

Steingo B, Subei A, Riser E, Gitt J, Stankiewicz J, Piccolo R, Wyse K, Weinstock-Guttman B. Immune response to influenza vaccine in patients with relapsing multiple sclerosis treated with ofatumumab: Results from an open-label, multicenter, phase 4 study. Mult Scler Relat Disord. 2025 May;97:106382. doi: 10.1016/j.msard.2025.106382. Epub 2025 Mar 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ofatumumab	Monoclonal antibody	20 mg	Subcutaneous
Subject	Quadrivalent influenza vaccine	Vaccine	—	—

A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

Summary

Timeline

Publications

Drugs

Indications