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Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.

NCT05084638

CompletedPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Relapse Remitting Multiple Sclerosis

Interventions: Ofatumumab

Countries: United States, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 35 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

Participants eligible for inclusion in this study must meet all of the following criteria:

1. Signed informed consent must be obtained prior to participation in the study
2. Age 18-35 years

Patients in the healthy control arm eligible for inclusion must fulfill the following criteria:
3. Able to obtain MRI (HC with abnormal MRI at Screening will be excluded) and use wearable device
4. Able to provide blood sample (no CSF will be collected in HC)

Patients in the ofatumumab-treated arm eligible for inclusion must fulfill the following criteria:
5. Diagnosis of RRMS per McDonald Criteria (2010/2017)
6. Within 6 months of diagnosis of clinically definite MS (CDMS)
7. EDSS 0-3.0 (Inclusive)
8. Treatment-naïve to MS DMT
9. Able to obtain MRI and attend study visits at sites
10. Able to use wearable device
11. Able to provide blood sample (and CSF for sub-group n=15)

Key Exclusion Criteria:

Participants in the healthy control arm meeting any of the following criteria are not eligible for inclusion in this study:

1. Confounding medical condition as determined by the investigator

RRMS patients fulfilling any of the following exclusion criteria are not eligible for inclusion in this study:
2. Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
3. Patients with neuromyelitis optica, Radiologic/ Clinically Isolated Syndrome, Secondary Progressive or Primary Progressive MS diagnosis
4. Use of experimental or investigational drugs for MS
5. Previous use of Disease Modifying Therapy (DMT) or chemotherapeutic medications for MS
6. Relapse between screening and Baseline visits
7. Known sensitivity to gadolinium; patients with chronic, severe kidney disease
8. Known history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
9. CNS anomalies that are better accounted for by another disease process or MRI anomalies causing clinically apparent impairments
10. Known active malignancies
11. Pregnant or nursing (lactating) women
12. Females of childbearing potential (all women physiologically capable of becoming pregnant) should use effective contraception while receiving ofatumumab and for 6 months after the last treatment of ofatumumab
13. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS or with immunodeficiency syndrome
14. Patients with active infections including systemic bacterial, viral (including SARS-CoV-2/COVID-19) or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening
15. Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
16. Patients with IgG or IgM levels below LLN at Screening
17. Patients that have received any live or live-attenuated vaccines within 4 weeks prior to first dose of study drug administration
18. Patients at risk of developing or having reactivation of hepatitis

Locations (36)

Chandler, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
Torrance, California, United States
West Hollywood, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Altamonte Springs, Florida, United States
Boca Raton, Florida, United States
Gainesville, Florida, United States
Maitland, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
New Orleans, Louisiana, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Reno, Nevada, United States
Hackensack, New Jersey, United States
Albuquerque, New Mexico, United States
Raleigh, North Carolina, United States
Dayton, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
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