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

Phase 4Active Not RecruitingNCT05090371

Novartis Pharmaceuticals136 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

136

Conditions

Relapsing-Remitting Multiple Sclerosis

Interventions

OfatumumabDRUG

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

Disease modifying treatment (DMT)DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (43)

Outcomes

Primary Outcomes

Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)

A participant is considered as achieved NEDA-3 if the participant has not had a clinical relapse (recurrence of a disease activity after a recovery), has not had an increase in disability and has no new radiological MRI activity (no new occurrences of contrast-enhancing lesions) during study Months 3 to 15.

Time frame: Months 3 to 15

Secondary Outcomes

Percentage of participants with a single baseline NfL≥10pg/ml and NfL<10pg/ml achieving NEDA-3 (No Evidence of Disease Activity-3)

Participants with a single baseline NfL≥10 pg/ml and NfL\<10pg/ml will be considered as achieved NEDA-3 if the participant has not had a clinical relapse (recurrence of a disease activity after a recovery), has not had an increase in disability and has no new radiological MRI activity (no new occurrences of contrast-enhancing lesions)

Time frame: Months 3 to15

Annualized relapse rate in Months 3 to 15

Relapses are recurrences of a disease activity after a recovery. A confirmed MS relapse is one accompanied by a clinically relevant change in the EDSS performed by the EDSS Rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores (FSs) or 2 points on one FS, excluding changes involving bowel/bladder or cerebral FS compared to the previous available rating (the last EDSS rating that did not occur during a relapse). Confirmation of MS relapse based on these definitions will be done centrally.

Time frame: Months 3 to 15

Percentage of participants without a worsening of their disability

No increase or worsening of disability

Time frame: Months 3 to 15

Percentage of participants with NEDA (No Evidence of Disease Activity) - Clinical

A participant is considered as achieved NEDA-clinical is no clinical relapse or disease progression (by EDSS) has occurred.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Alabama Neurology Associates PC

Birmingham, Alabama, United States

North Central Neurology Associates PC

Cullman, Alabama, United States

Radiant Research Chandler

Chandler, Arizona, United States

Arizona Neuroscience Research LLC

Phoenix, Arizona, United States

University of California at Los Angeles

Torrance, California, United States

Neurology of Central FL Res Ctr

Altamonte Springs, Florida, United States

S And D Clinical Research

Cape Coral, Florida, United States

Homestead Assoc In Research Inc

Homestead, Florida, United States

Neurology Associates PA

Maitland, Florida, United States

Orlando Health Clinical Trials

Orlando, Florida, United States

...and 33 more locations

Time frame: Months 3 to 15

Percentage of participants with NEDA (No Evidence of Disease Activity) - Radiological

A participant is considered as achieved NEDA-radiological if the participant has has no new radiological MRI activity (no new occurrences of contrast-enhancing lesions) during study Months 3 to 15.

Time frame: Months 3 to 15

Mean change in The Symbol-Digit Modality Test

This test measures cognition in patients with MS. Patients are asked to substitute a number, either orally or written, for randomized presentations of geometric figures.