CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 180 enrolled
Drug / intervention
Ofatumumabdrug
Likely dose
Ofatumumab 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05084638
NCT05084638Phase 4Completed

AGNOS: An 18-month, Open-label, Multi-Center Phase IV Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naïve, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.

Novartis Pharmaceuticals·interventional·Posted Oct 20, 2021·Updated Feb 27, 2026

In Brief

A Phase 4 clinical trial evaluating Ofatumumab for Relapse Remitting Multiple Sclerosis. Completed, enrolled 180 participants across 36 sites in 2 countries.

Detailed Summary

This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes. The study also assesses changes in disease using monitoring techniques including digital biometric device use, biomarker analysis and non-conventional MRI. Select outcomes in the ofatumumab treated group will be compared to a group of Healthy participants to determine if there are similarities between the groups after the patients with MS undergo treatment with ofatumumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedOct 20, 2021
Enrollment StartJan 25, 2022
Primary CompletionFeb 4, 2025
Study CompletionFeb 11, 2026
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 4.7 years ago

Interventions

Ofatumumabdrug

20mg subcutaneous injection