NCT06869785

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Relapsing Multiple Sclerosis (RMS)

Interventions

Type	Name	Description
BIOLOGICAL	Ofatumumab approved dose	Approved dosage
BIOLOGICAL	Ofatumumab new dose	New dosage

Timeline

• Start date: 2025-03-13
• Primary completion: 2026-03-11
• Completion: 2030-03-23
• First posted: 2025-03-11
• Last updated: 2026-03-20

Locations

63 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study