Ofatumumab for Multiple Sclerosis

(ARTIOS Trial)

Recruiting at 149 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must be taking: Fumarates, Fingolimod

Must not be taking: Corticosteroids, Ofatumumab

Disqualifiers: Primary progressive MS, AIDS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

562 Participants Needed

Trial Summary

What is the purpose of this trial?

Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.

Eligibility Criteria

This trial is for people with relapsing forms of Multiple Sclerosis (RMS), including secondary progressive MS, who have tried up to three Disease Modifying Therapies. Participants should have an EDSS score from 0 to 4 and must be transitioning from fumarate-based therapies or fingolimod due to disease activity despite treatment.

Inclusion Criteria

Diagnosis of MS according to the 2017 Revised McDonald criteria

My disability level is low to moderate.

My neurological condition has been stable for the last month.

Exclusion Criteria

Pregnant or nursing women

I have been diagnosed with neuromyelitis optica.

My MS is either primary progressive or secondary progressive without recent activity.

Treatment Details

Interventions

• Ofatumumab

Trial Overview The study tests the effectiveness of Ofatumumab in patients switching from fumarate-based RMS therapies or fingolimod because their MS was active even while on these treatments. It's an open-label trial, meaning both researchers and participants know what treatment is being given.

Participant Groups

Group I: Ofatumumab Experimental Treatment 1 Intervention

Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days

Ofatumumab is already approved in European Union, United States for the following indications:

Approved in European Union as Kesimpta for:

• Relapsing forms of multiple sclerosis (MS)
• Clinically isolated syndrome
• Relapsing-remitting multiple sclerosis
• Active secondary progressive multiple sclerosis

Approved in United States as Kesimpta for:

• Relapsing forms of multiple sclerosis (MS)
• Clinically isolated syndrome
• Relapsing-remitting multiple sclerosis
• Active secondary progressive multiple sclerosis

Approved in United States as Arzerra for:

• Certain types of chronic lymphocytic leukemia (CLL)

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD