New MS drug ofatumumab goes Head-to-Head with standard treatments in major trial

NCT ID NCT04788615

Completed Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 study tested whether ofatumumab, a monthly injection, works better than standard first-line disease-modifying therapies (like glatiramer acetate or interferon) in people newly diagnosed with relapsing multiple sclerosis. The main goal was to see if more patients could achieve 'no evidence of disease activity'—meaning no relapses, no new brain lesions, and no worsening disability. The trial enrolled 185 adults aged 18–55 who had not taken any MS treatment before.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Ofatumumab (a monthly injection) or a standard first-line disease-modifying therapy (such as glatiramer acetate, interferon, teriflunomide, or dimethyl fumarate)
What this could lead to: If ofatumumab works better than standard therapies, it could become a new first-choice treatment to control relapsing MS and prevent disability worsening.
What could go wrong: This is a completed Phase 3 trial, but results are not yet published. Ofatumumab may not prove superior to existing options, and all MS treatments carry risks like infections or injection reactions.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MULTIPLE SCLEROSIS

Contacts and locations

Locations

Novartis Investigative Site

Bayonne, Bayonne Cedex, 64109, France
Novartis Investigative Site

Amiens, 80054, France
Novartis Investigative Site

Bordeaux, 33076, France
Novartis Investigative Site

Clermont-Ferrand, 63003, France
Novartis Investigative Site

Créteil, 94010, France
Novartis Investigative Site

Gonesse, 95500, France
Novartis Investigative Site

Grenoble, 38043, France
Novartis Investigative Site

Montpellier, 34090, France
Novartis Investigative Site

Nice, 06202, France
Novartis Investigative Site

Nîmes, 30029, France
Novartis Investigative Site

Poissy, 78303, France
Novartis Investigative Site

Rennes, 35033, France
Novartis Investigative Site

Strasbourg, 67000, France
Novartis Investigative Site

Frankfurt am Main, Hesse, 60590, Germany
Novartis Investigative Site

Westerstede, Lower Saxony, 26655, Germany
Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany
Novartis Investigative Site

Bayreuth, 95445, Germany
Novartis Investigative Site

Berlin, 12101, Germany
Novartis Investigative Site

Berlin, 13353, Germany
Novartis Investigative Site

Bielefeld, 33647, Germany
Novartis Investigative Site

Dortmund, 44137, Germany
Novartis Investigative Site

Heidelberg, 69120, Germany
Novartis Investigative Site

Siegen, 57076, Germany
Novartis Investigative Site

Ulm, 89073, Germany
Novartis Investigative Site

Montichiari, BS, 25018, Italy
Novartis Investigative Site

Milan, MI, 20132, Italy
Novartis Investigative Site

Roma, RM, 00133, Italy
Novartis Investigative Site

Roma, RM, 00189, Italy
Novartis Investigative Site

Orbassano, TO, 10043, Italy
Novartis Investigative Site

Naples, 80131, Italy
Novartis Investigative Site

Santiago Compostela, A Coruna, 15706, Spain
Novartis Investigative Site

Salt, Girona, 17190, Spain
Novartis Investigative Site

El Palmar, Murcia, 30120, Spain
Novartis Investigative Site

Barakaldo, Vizcaya, 48903, Spain
Novartis Investigative Site

Barcelona, 08035, Spain
Novartis Investigative Site

Madrid, 28009, Spain
Novartis Investigative Site

Madrid, 28034, Spain
Novartis Investigative Site

Madrid, 28040, Spain
Novartis Investigative Site

Málaga, 29010, Spain
Novartis Investigative Site

Seville, 41009, Spain
Novartis Investigative Site

Valencia, 46026, Spain

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