Active Not Recruiting INTERVENTIONAL NCT06869785

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab (FILIOS)

An Open-label, Randomized, Parallel Group, Non-inferiority Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab, Followed by Extended Treatment in Participants With Relapsing Multiple Sclerosis

Sponsor: Novartis Pharmaceuticals

Conditions Relapsing Multiple Sclerosis (RMS)

Interventions Ofatumumab approved dose Ofatumumab new dose

Updated 10 times since 2025 Last updated: Apr 20, 2026 Started: Mar 13, 2025 Primary completion: Jan 28, 2026 Completion: Mar 23, 2030

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Relapsing Multiple Sclerosis (RMS), this trial is ongoing. The trial is conducted by Novartis Pharmaceuticals and has accumulated 10 data snapshots since 2025. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

This is a Phase 3, open label, parallel-group, multicenter study in participants with relapsing multiple sclerosis

Status Flow

Change History

10 versions recorded

Apr 21, 2026 — Present [daily]

Active Not Recruiting

Phase: PHASE3 → None
Feb 2026 — Apr 2026 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Jan 2026 — Feb 2026 [monthly]

Recruiting PHASE3
Dec 2025 — Jan 2026 [monthly]

Recruiting PHASE3
Nov 2025 — Dec 2025 [monthly]

Recruiting PHASE3

▶ Show 5 earlier versions

Sep 2025 — Nov 2025 [monthly]

Recruiting PHASE3
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE3
Jul 2025 — Aug 2025 [monthly]

Recruiting PHASE3
May 2025 — Jul 2025 [monthly]

Recruiting PHASE3
Apr 2025 — May 2025 [monthly]

Recruiting PHASE3

First recorded

Mar 2025

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.

Contact Information

Sponsor contact:

Novartis Pharmaceuticals

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Alexandria, United States , Altamonte Springs, United States , Arlington, United States , Atlanta, United States , Aurora, United States , Berkeley, United States , Bethesda, United States , Birmingham, United States , Boca Raton, United States , Boca Raton, United States and 53 more locations