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A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation

Study Purpose

This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 50 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Signed informed consent must be obtained prior to participation in the study.

- Age 18-45 years.

- Diagnosis of RRMS per McDonald Criteria (2017) - EDSS 0-5.5 (Inclusive) - Able to obtain MRI and attend study visits at sites.

- Willing to use wearable device as specified in the protocol.

- Able to provide blood sample.

- On a current DMT with approved label use for treatment of RRMS at least 6 months prior to Screening.

- No relapse reported within 6 months prior to Screening.

- Patients may enroll in the trial if they have subclinical disease activity as measured by MRI prior to enrollment.

An absence of MRI activity is not exclusionary.

Exclusion Criteria:

- Primary progressive or secondary progressive phenotype.

- Diseases other than multiple sclerosis responsible for the clinical or MRI presentation.

- Use of experimental or investigational drugs for MS within 2 years from Screening.

- Known sensitivity to gadolinium.

- Central Nervous System (CNS) anomalies that are better accounted for by another disease process.

- Known active malignancies.

- Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS.

- Active infections including systemic bacterial, viral (including COVID-19) or fungal infections, known to have AIDS or tested positive for HIV antibodies.

- Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML.

- IgG or IgM levels below lower limit of normal (LLN) at Screening

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05090371
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsing-Remitting Multiple Sclerosis

Additional Details

This is a multicenter, prospective study of up to 150 relapsing-remitting MS participants/ The study is looking to see if patients who have not had a relapse in the past year would benefit from switching to ofatumumab. After giving consent, participants will have a 1 week screening/qualification period. If they qualify to continue, they will start a a six month run-in period during which lab samples will be collected. Patients that are relapse-free during the run-in period will continue into next period of the study in which they will be randomized to either ofatumumab or continued therapy for the next 15 months. Every 3 out of 5 randomized participants will be selected to wear a digital study watch to collect physical activity, sleep, and vitals during this 15 month period. The study watch will be worn 24 hours a day, 7 days a week but can be removed during showers/bathing. At the end of the 15 month period, a study completion visit will be held. The total study duration is 21 months plus 1 week for screening/qualification.

Arms & Interventions

Arms

Experimental: Ofatumumab

20 mg

Active Comparator: DMT continued therapy

Participants randomized to the continued therapy arm will continue to take their disease modifying treatment (DMT) as prescribed commercially by their physician.

Interventions

Drug: - Ofatumumab

3 loading doses followed by administration every 4 weeks as per label

Drug: - Disease modifying treatment (DMT)

Other DMT with approved label use for treatment which participants were on at least 6 months prior to Screening

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Recruiting

Address

Alabama Neurology Associates PC CFTY720D2403

Birmingham, Alabama, 35209

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